StemCell Therapy

LASIK in Norfolk Virginia Beach Chesapeake VA Highly Skilled in Laser Vision Correction

At Virginia Eye Consultants, we offer only the safest, most effective eye treatments available. Our team is composed of extensively trained eye care professionals who have particular expertise in laser vision correction. With procedures like LASIK and PRK becoming such well-known solutions for refractive errors, we take pride in educating our patients on these advanced laser options. Both LASIK and PRK are revolutionary procedures that have proven to significantly impact our patients lives, often eliminating their need to wear glasses or contact lenses.

Our highly skilled ophthalmologists are more than happy to discuss laser vision correction with you, answering any questions or concerns you may have.

Eliminate cloudy vision with laser surgery

Many of us will develop cataracts as we age, and if left untreated, this prevalent condition can lead to progressive vision loss. With laser cataract surgery, we can restore your eye health.

Say goodbye to glasses and contacts

If youre ready to eliminate the need for corrective eyewear, LASIK might be the perfect solution for you! Utilizing state-of-the-art laser technology, our team can help you see clearly again.

Restore age-related vision loss

Once you hit a certain age, your eyes lose their ability to focus on nearby objects. Reduce your need for reading glasses.

Retain your natural tears

Dry eyes are one of the most common reasons people visit their eye doctor. Our team offers effective treatment for this syndrome to help resolve your discomfort and prevent future issues.

The seeing tissue of the eye

Your retina transforms filtered light into images to be sent to your brain. When this tissue is damaged, objects may appear blurry, which is why a healthy retina is so crucial for your vision.

Early detection for long-term control

Those who suffer from glaucoma have an elevated eye pressure, which can gradually take a toll on their eyesight. When detected early and treated properly, you can slow the diseases.

Rejuvenate your facial appearance

From BOTOX injections to skin care products, our team offers various cosmetic solutions to enhance your appearance and ultimately help you feel more confident about the face you see in the mirror.

Eliminate cloudy vision with laser surgery

Many of us will develop cataracts as we age, and if left untreated, this prevalent condition can lead to progressive vision loss. With laser cataract surgery, we can restore your eye health.

Say goodbye to glasses and contacts

If youre ready to eliminate the need for corrective eyewear, LASIK might be the perfect solution for you! Utilizing state-of-the-art laser technology, our team can help you see clearly again.

Restore age-related vision loss

Once you hit a certain age, your eyes lose their ability to focus on nearby objects. Reduce your need for reading glasses.

Retain your natural tears

Dry eyes are one of the most common reasons people visit their eye doctor. Our team offers effective treatment for this syndrome to help resolve your discomfort and prevent future issues.

The seeing tissue of the eye

Your retina transforms filtered light into images to be sent to your brain. When this tissue is damaged, objects may appear blurry, which is why a healthy retina is so crucial for your vision.

Early detection for long-term control

Those who suffer from glaucoma have an elevated eye pressure, which can gradually take a toll on their eyesight. When detected early and treated properly, you can slow the diseases.

Rejuvenate your facial appearance

From BOTOX injections to skin care products, our team offers various cosmetic solutions to enhance your appearance and ultimately help you feel more confident about the face you see in the mirror.

The quiz below is a great start to finding out if youre a candidate for LASIK vision.

The quiz below is a great start to finding out your Ocular Surface Disease Index (OSDI).

Our team of ophthalmologists and optometrists are highly experienced in providing the latest eye care solutions. We are committed to helping you achieveand maintainclear vision and good eye health through state-of-the-art treatment options.

I was very impressed with both Dr. Scoper and the staff and the results of my procedure are amazing (LASIK). It has been 3 months since my correction in both eyes, the results are amazing. The facility is pretty impressive, and they obviously move a lot of patients through here, but I found the staff to be friendly and caring.

The staff at the Military Highway location are wonderful. They quickly greet you and offer you coffee, tea and yummy shortbread cookies. VA Eye consultants always works to coordinate care with my sister's primary care physician and eye doctor without making us carry records all around town. They also work with our pharmacist to make sure the prescription they provide is covered by her medical plan. We have seen Dr. Whitley, Dr. Salib and Dr. Joly. Wonderful professionals!

From the moment, I made my appointment for a consultation to the very end of the surgery, it was amazing! At my consultation, the entire staff was super friendly and made me feel comfortable. They walked me through all the different test they were going to do on my eyes, answered any question I had and even got to know a little about me. (Which made me feel like a person whether than a potential patient) . I recommend Virginia Eye Consultants for LASIK eye surgery over any other place. You don't just get better vision... You get trusted doctors and staff members who love what they do and do it amazingly well.

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Virginia Eye Consultants - LASIK in Norfolk Virginia Beach ...

The stem cells in cord blood are currently approved by the FDA for the treatment of nearly 80 diseases, but they are still showing a lot of promise in a number of other conditions from multiple sclerosis to autism. There is a lot of excitement around the possible future uses of cord tissue, which has stem cells that can become new neural, bone, fat and cartilage tissue and could be utilized in things like sports injuries and severe burns.

Unfortunately, the years between the initial promise shown in these stem cells (especially as they are quick to make headlines) and full FDA approval as a safe and effective therapy has led some people to seek treatments outside current FDA-approved channels. This can involve going to another country to receive a treatment that has yet to be approved in the U.S. or taking part in a treatment that is not a part of an FDA-approved clinical trial.

Drew Pomeranz has made a bit of a comeback after receiving a stem cell infusion for an injury to his elbow

From Peyton Manning reportedly flying to Germany in 2011 for a bulging disk in his neck to Drew Pomeranz receiving an injection in his elbow earlier this year, many have been taking leaps of faith with stem cells treatments outside approved channels. And controversy has followed.

Traveling abroad to receive stem cell treatments outside of those currently approved by the FDA has been getting media attention ever since the promise of stem cell therapies first started making headlines, and these stories are not limited to all-star players either. Earlier this year, a BBC news correspondent said a stem cell therapy in Mexico helped significantly improve the symptoms of her multiple sclerosis, and the Shetland Times has been following one woman who feels a million times better after going to the same country to treat the same condition.

What began with so-called destination healthcare or medical tourism has turned into the recent proliferation of centers in the U.S. practicing what some would consider to be experimental treatments. With them has come an inundation of direct-to-consumer marketing proclaiming benefits that go beyond current research. Let's look at why people have been going outside the scope of FDA-approved treatments and what risks they are taking.

Peyton Manning may be one of the bigger names, and despite the exact outcome being unknown, it definitely added to the exposure the practice was getting earlier this decade. Soter Healthcare, a U.S. facility that specializes in destination healthcare services, says this is because the United States has lagged behind other countries in this field:

For more than 15 years, China has been actively involved in stem cell research, and its scientists and physicians today produce more scholarly papers on the subject than any other nation. In the U.S., stem cell treatment is still years away from approval.

David Mair is the founder of Soter Healthcare and has long advocated the advancements in other countries.

The Chinese, the Germans and the Israelis are among the leaders in the world in stem cell care right now, Mair said in 2011. Today, Mair says the gap has decreased, but we're still lagging behind other nations.

Mair has seen the benefits of going abroad for experimental treatments firsthand. His niece was the subject of a story in the Washington Post in 2010 about her treatment in China for cerebral palsy. The father called the developments unbelievable, and Mair later summed up many of her advancements:

Today, she walks with a single crutch, he said in 2012. She now can use her left-hand independently for major motor skill range of motions. She walks extended distances, her stamina and walking gait are far better, her vision and voice modulate is much better, and she is reading at her grade-level.

Family Guy put the blame on funding although much of its portrayal on the subject, in a typical manner, was over-exaggerated

If this lag in stem cell research in the U.S. is real, it could be because embryonic stem cellsa particular kind of stem cell found in the early stages of gestationand various ethical considerations raised in their use have imbued a bad name on all stem cells. The way Americans feel about embryonic stem cell research went all the way to the White House, with President George Bush, in 2001, limiting research in that category and President Obama later overturning the former presidents order. Regulations, however, still may be hampering progress despite cord bloodderived stem cells, stem cells that form just a little bit later down the road from embryonic stem cells and can be procured with no harm to the baby or child, not having the same ethical considerations or roadblocks.

Dr. Adam Anz of the Andrews Institute for Orthopaedics and Sports Medicine, is one U.S. scientist investigating the benefits of stem cells and is looking into how they could repair cartilage in knee injuries. He is just awaiting FDA approval.

Regulation is good, but that regulation needs to be tailored toward these emerging technologies, said Dr. Anz, who believes the REGROW act in Congress could help create more clinical trials by allowing small clinics and university labs to charge for participation.

The REGROW act would provide parents with better access to trial therapies and lead to accelerated adoption of stem cell treatments.

While people may think they are simply taking advantage of a treatment that has yet to be approved in their country or their situation is so dire that they have nothing to lose, experts warn against procedures that have yet to fully vetted in countries without the proper medical controls. Short- and long-term complications are possible, and there is always the possibility it will make the condition worse or even cause death.

The X-Cell Center is Germany is one institution that seemed to have all the opulent trappings of a well-to-do stem cell treatment center. That was until it was shut down in 2011 by the German government for deaths that occurred in 2010. Since, the X-Cell Center has re-opened in Lebanon under a new name but practicing the same types of treatments.

"Regulatory agencies such as the FDA can ensure that cell therapy that reaches patients is safe (and) effective and that quality control is established for isolating the cells, manipulating them outside of the body, and delivering them," said Jeffrey Karp, director of the Laboratory for Advanced Biomaterials and Stem-Cell-Based Therapeutics at Brigham and Women's Hospital in Cambridge, Massachusetts.

Obtaining adipose-derived stem cells requires a liposuction-like procedure that could feel like a side benefit to some patients

Like Peyton Manning, Chris Johnson, who is a three-time NFL Pro Bowler and once raced a cheetah for a National Geographic segment, also had a stem cell injection. But this one took place in Gulf Breeze, Fla. It is one of many new stem cell clinics in the United States that sidestep FDA regulations by using unadulterated stem cells mainly acquired through the patients adipose fat cells. This is in contrast to similar services in other countries that also use adipose stem cells but multiply their number by some 200 times before re-introducing them back into the body. The FDA warns against treatment using fat-derived stem cells, saying they are being used on the basis of minimal clinical evidence of safety or efficacy, sometimes with the claims that they constitute revolutionary treatments for various conditions.

A study of some of these types of clinics recently made headlines because of their direct-to-consumer advertising practices, which seemed to proclaim stem cells as the cure-all for nearly everything. The FDA now says it is going to crack down on unscrupulous stem cell clinics while easing the path to approval for legitimate treatments.

Mair agrees that these unauthorized clinics need to be shutdown but the FDA needs to be careful to not put restrictions on all clinics for a few bad actors. Mair spoke specifically about a case in Florida where three women were left nearly or totally blind after mesenchymal stem cells from their adipose fat tissue were injected into their eyes.

"We can't allow stuff like what happened to those women in Florida," said Mair. "I'm O.K. with mesenchymal stem cells used in osteoarthritis where global evidence suggests that it is a very strong alternative for people in their 40s and 50s who need a knee replacement," he added.

International Society for Stem Cell Research (ISSCR), a company that, as the name implies, promotes stem cell research proffers these safety tips:

As we see it, stem cell research is still 27 years young and has much further to go. As the FDA process ensures that treatments are safe and effective, we must put faith in its methods even if it causes some delays. The FDA's oversight and tracking of outcomes in stem cell transplantations has led to safer treatment options for everyone, and participation in multiple clinical trials is an important step in proving the safety and efficacy of therapies for the general public. We do realize the some people may feel as though they are in a situation where they cannot wait for full FDA approval. For the rest, we will look for the day when these cord blood and cord tissue transplantations will have gone through the required protocal and be included in the arsenal of standard stem cell treatment options currently available.

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A new treatment for macular degeneration is close to the next stage of human testinga noteworthy event not just for the millions of patients it could help, but for its potential to become the first therapy based on embryonic stem cells.

This year, the Boston-area company Advanced Cell Technology plans to move its stem-cell treatment for two forms of vision loss into advanced human trials. The company has already reported that the treatment is safe (see Eye Study Is a Small but Crucial Advance for Stem-Cell Therapy), although a full report of the results from the early, safety-focused testing has yet to be published. The planned trials will test whether it is effective. The treatment will be tested both on patients with Stargardts disease (an inherited form of progressive vision loss that can affect children) and on those with age-related macular degeneration, the leading cause of vision loss among people 65 and older.

The treatment is based on retinal pigment epithelium (RPE) cells that have been grown from embryonic stem cells. A surgeon injects 150 microliters of RPE cellsroughly the amount of liquid in three raindropsunder a patients retina, which is temporarily detached for the procedure. RPE cells support the retinas photoreceptors, which are the cells that detect incoming light and pass the information on to the brain.

Although complete data from the trials of ACTs treatments have yet to be published, the company has reported impressive results with one patient, who recovered vision after being deemed legally blind. Now the company plans to publish the data from two clinical trials taking place in the U.S. and the E.U. in a peer-reviewed academic journal. Each of these early-stage trials includes 12 patients affected by either macular degeneration or Stargardts disease.

The more advanced trials will have dozens of participants, says ACTs head of clinical development, Eddy Anglade. If proved safe and effective, the cellular therapy could preserve the vision of millions affected by age-related macular degeneration. By 2020, as the population ages, nearly 200 million people worldwide will have the disease, estimate researchers. Currently, there are no treatments available for the most common form, dry age-related macular degeneration.

ACTs experimental treatment has its origins in a chance discovery that Irina Klimanskaya, the companys director of stem-cell biology, made while working with embryonic stem cells at Harvard University. These cells have the power to develop into any cell type, and in culture they often change on their own. A neuron here, a fat cell thereindividual cells in a dish tend to take random walks down various developmental paths. By supplying the cultures with fresh nutrients but otherwise leaving them to their own devices for several weeks, Klimanskaya discovered that the stem cells often developed into darkly pigmented cells that grew in a cobblestone-like pattern. She suspected that they were developing into RPE cells, and molecular tests backed her up.

Now that her discovery has advanced into an experimental treatment, Klimanskaya says she is excited by the hints that it may be able to preserve, and perhaps restore, sight. She recalls a voice mail she received during her second year at ACT: a person blinded by an inherited condition thanked her for her work, whether or not there was a treatment available for him. When you get a message like this, you feel like you are not doing it in vain, she says.

See the article here:
Stem-Cell Treatment for Blindness Moving Through Patient ...

2 Corinthians 4:4ESV / 4,056 helpful votesHelpfulNot Helpful

In their case the god of this world has blinded the minds of the unbelievers, to keep them from seeing the light of the gospel of the glory of Christ, who is the image of God.

Let them alone; they are blind guides. And if the blind lead the blind, both will fall into a pit.

And even if our gospel is veiled, it is veiled only to those who are perishing. In their case the god of this world has blinded the minds of the unbelievers, to keep them from seeing the light of the gospel of the glory of Christ, who is the image of God.

For God, who said, Let light shine out of darkness, has shone in our hearts to give the light of the knowledge of the glory of God in the face of Jesus Christ.

Jesus said, For judgment I came into this world, that those who do not see may see, and those who see may become blind.

The natural person does not accept the things of the Spirit of God, for they are folly to him, and he is not able to understand them because they are spiritually discerned.

Again Jesus spoke to them, saying, I am the light of the world. Whoever follows me will not walk in darkness, but will have the light of life.

The Spirit of the Lord is upon me, because he has anointed me to proclaim good news to the poor. He has sent me to proclaim liberty to the captives and recovering of sight to the blind, to set at liberty those who are oppressed,

For you say, I am rich, I have prospered, and I need nothing, not realizing that you are wretched, pitiable, poor, blind, and naked.

But whoever hates his brother is in the darkness and walks in the darkness, and does not know where he is going, because the darkness has blinded his eyes.

He has blinded their eyes and hardened their heart, lest they see with their eyes, and understand with their heart, and turn, and I would heal them.

The Lord opens the eyes of the blind. The Lord lifts up those who are bowed down; the Lord loves the righteous.

Jesus said, For judgment I came into this world, that those who do not see may see, and those who see may become blind. Some of the Pharisees near him heard these things, and said to him, Are we also blind? Jesus said to them, If you were blind, you would have no guilt; but now that you say, We see, your guilt remains.

But you are a chosen race, a royal priesthood, a holy nation, a people for his own possession, that you may proclaim the excellencies of him who called you out of darkness into his marvelous light.

I will bring distress on mankind, so that they shall walk like the blind, because they have sinned against the Lord; their blood shall be poured out like dust, and their flesh like dung.

For at one time you were darkness, but now you are light in the Lord. Walk as children of light

Lest you be wise in your own sight, I want you to understand this mystery, brothers: a partial hardening has come upon Israel, until the fullness of the Gentiles has come in.

Woe to you, blind guides, who say, If anyone swears by the temple, it is nothing, but if anyone swears by the gold of the temple, he is bound by his oath.

The light shines in the darkness, and the darkness has not overcome it.

Open my eyes, that I may behold wondrous things out of your law.

Then the eyes of the blind shall be opened, and the ears of the deaf unstopped;

To open their eyes, so that they may turn from darkness to light and from the power of Satan to God, that they may receive forgiveness of sins and a place among those who are sanctified by faith in me.

For the mind that is set on the flesh is hostile to God, for it does not submit to God's law; indeed, it cannot.

He answered, Whether he is a sinner I do not know. One thing I do know, that though I was blind, now I see.

But seek first the kingdom of God and his righteousness, and all these things will be added to you.

As he passed by, he saw a man blind from birth. And his disciples asked him, Rabbi, who sinned, this man or his parents, that he was born blind? Jesus answered, It was not that this man sinned, or his parents, but that the works of God might be displayed in him. We must work the works of him who sent me while it is day; night is coming, when no one can work. As long as I am in the world, I am the light of the world. ...

Whoever says he is in the light and hates his brother is still in darkness.

For since, in the wisdom of God, the world did not know God through wisdom, it pleased God through the folly of what we preach to save those who believe.

But to this day the Lord has not given you a heart to understand or eyes to see or ears to hear.

Knowing this first of all, that scoffers will come in the last days with scoffing, following their own sinful desires.

But for those who are self-seeking and do not obey the truth, but obey unrighteousness, there will be wrath and fury.

Whom have you mocked and reviled? Against whom have you raised your voice and lifted your eyes to the heights? Against the Holy One of Israel!

And no wonder, for even Satan disguises himself as an angel of light.

To the choirmaster. Of David. The fool says in his heart, There is no God. They are corrupt, they do abominable deeds, there is none who does good.

They said to you, In the last time there will be scoffers, following their own ungodly passions.

The one who rejects me and does not receive my words has a judge; the word that I have spoken will judge him on the last day.

This is why I speak to them in parables, because seeing they do not see, and hearing they do not hear, nor do they understand.

And I will lead the blind in a way that they do not know, in paths that they have not known I will guide them. I will turn the darkness before them into light, the rough places into level ground. These are the things I do, and I do not forsake them.

For this people's heart has grown dull, and with their ears they can barely hear, and their eyes they have closed, lest they should see with their eyes and hear with their ears and understand with their heart and turn, and I would heal them.

And you shall grope at noonday, as the blind grope in darkness, and you shall not prosper in your ways. And you shall be only oppressed and robbed continually, and there shall be no one to help you.

But Jesus went to the Mount of Olives. Early in the morning he came again to the temple. All the people came to him, and he sat down and taught them. The scribes and the Pharisees brought a woman who had been caught in adultery, and placing her in the midst they said to him, Teacher, this woman has been caught in the act of adultery. Now in the Law Moses commanded us to stone such women. So what do you say? ...

And the Word became flesh and dwelt among us, and we have seen his glory, glory as of the only Son from the Father, full of grace and truth.

And as Jesus passed on from there, two blind men followed him, crying aloud, Have mercy on us, Son of David. When he entered the house, the blind men came to him, and Jesus said to them, Do you believe that I am able to do this? They said to him, Yes, Lord. Then he touched their eyes, saying, According to your faith be it done to you. And their eyes were opened. And Jesus sternly warned them, See that no one knows about it.

You are of your father the devil, and your will is to do your father's desires. He was a murderer from the beginning, and has nothing to do with the truth, because there is no truth in him. When he lies, he speaks out of his own character, for he is a liar and the father of lies.

Yes, to this day whenever Moses is read a veil lies over their hearts.

They have neither knowledge nor understanding, they walk about in darkness; all the foundations of the earth are shaken.

As it is written, God gave them a spirit of stupor, eyes that would not see and ears that would not hear, down to this very day.

To open the eyes that are blind, to bring out the prisoners from the dungeon, from the prison those who sit in darkness.

He has delivered us from the domain of darkness and transferred us to the kingdom of his beloved Son,

Hear, you deaf, and look, you blind, that you may see!

Jesus heard that they had cast him out, and having found him he said, Do you believe in the Son of Man? He answered, And who is he, sir, that I may believe in him? Jesus said to him, You have seen him, and it is he who is speaking to you. He said, Lord, I believe, and he worshiped him. Jesus said, For judgment I came into this world, that those who do not see may see, and those who see may become blind. ...

No one can come to me unless the Father who sent me draws him. And I will raise him up on the last day.

And the great dragon was thrown down, that ancient serpent, who is called the devil and Satan, the deceiver of the whole worldhe was thrown down to the earth, and his angels were thrown down with him.

Paul, a servant of Christ Jesus, called to be an apostle, set apart for the gospel of God, which he promised beforehand through his prophets in the holy Scriptures, concerning his Son, who was descended from David according to the flesh and was declared to be the Son of God in power according to the Spirit of holiness by his resurrection from the dead, Jesus Christ our Lord, through whom we have received grace and apostleship to bring about the obedience of faith for the sake of his name among all the nations, ...

In order that all may be condemned who did not believe the truth but had pleasure in unrighteousness.

But to all who did receive him, who believed in his name, he gave the right to become children of God, who were born, not of blood nor of the will of the flesh nor of the will of man, but of God.

He answered, The man called Jesus made mud and anointed my eyes and said to me, Go to Siloam and wash. So I went and washed and received my sight.

Bring out the people who are blind, yet have eyes, who are deaf, yet have ears!

Jesus heard that they had cast him out, and having found him he said, Do you believe in the Son of Man?

But when one turns to the Lord, the veil is removed.

And this is the judgment: the light has come into the world, and people loved the darkness rather than the light because their works were evil.

And this is the judgment: the light has come into the world, and people loved the darkness rather than the light because their works were evil. For everyone who does wicked things hates the light and does not come to the light, lest his works should be exposed.

So that we would not be outwitted by Satan; for we are not ignorant of his designs.

In the beginning was the Word, and the Word was with God, and the Word was God.

Now this I say and testify in the Lord, that you must no longer walk as the Gentiles do, in the futility of their minds. They are darkened in their understanding, alienated from the life of God because of the ignorance that is in them, due to their hardness of heart. They have become callous and have given themselves up to sensuality, greedy to practice every kind of impurity.

That is why many of you are weak and ill, and some have died.

Put on the whole armor of God, that you may be able to stand against the schemes of the devil.

For the mind that is set on the flesh is hostile to God, for it does not submit to God's law; indeed, it cannot. Those who are in the flesh cannot please God.

For whoever lacks these qualities is so nearsighted that he is blind, having forgotten that he was cleansed from his former sins.

And as Jesus passed on from there, two blind men followed him, crying aloud, Have mercy on us, Son of David. When he entered the house, the blind men came to him, and Jesus said to them, Do you believe that I am able to do this? They said to him, Yes, Lord. Then he touched their eyes, saying, According to your faith be it done to you. And their eyes were opened. And Jesus sternly warned them, See that no one knows about it. But they went away and spread his fame through all that district.

Then Jesus said to the crowds and to his disciples, The scribes and the Pharisees sit on Moses' seat, so practice and observe whatever they tell youbut not what they do. For they preach, but do not practice. They tie up heavy burdens, hard to bear, and lay them on people's shoulders, but they themselves are not willing to move them with their finger. They do all their deeds to be seen by others. For they make their phylacteries broad and their fringes long, ...

The brothers immediately sent Paul and Silas away by night to Berea, and when they arrived they went into the Jewish synagogue. Now these Jews were more noble than those in Thessalonica; they received the word with all eagerness, examining the Scriptures daily to see if these things were so.

In that day you will know that I am in my Father, and you in me, and I in you. Whoever has my commandments and keeps them, he it is who loves me. And he who loves me will be loved by my Father, and I will love him and manifest myself to him. Judas (not Iscariot) said to him, Lord, how is it that you will manifest yourself to us, and not to the world? Jesus answered him, If anyone loves me, he will keep my word, and my Father will love him, and we will come to him and make our home with him.

For the Lord has poured out upon you a spirit of deep sleep, and has closed your eyes (the prophets), and covered your heads (the seers).

For the word of the cross is folly to those who are perishing, but to us who are being saved it is the power of God.

Saul rose from the ground, and although his eyes were opened, he saw nothing. So they led him by the hand and brought him into Damascus.

But if your eye is bad, your whole body will be full of darkness. If then the light in you is darkness, how great is the darkness!

For we do not have a high priest who is unable to sympathize with our weaknesses, but one who in every respect has been tempted as we are, yet without sin.

Whoever loves his brother abides in the light, and in him there is no cause for stumbling.

But blessed are your eyes, for they see, and your ears, for they hear.

And he said, Who are you, Lord? And he said, I am Jesus, whom you are persecuting.

He is the image of the invisible God, the firstborn of all creation. For by him all things were created, in heaven and on earth, visible and invisible, whether thrones or dominions or rulers or authoritiesall things were created through him and for him.

Again he appoints a certain day, Today, saying through David so long afterward, in the words already quoted, Today, if you hear his voice, do not harden your hearts.

And they may come to their senses and escape from the snare of the devil, after being captured by him to do his will.

Finally, be strong in the Lord and in the strength of his might. Put on the whole armor of God, that you may be able to stand against the schemes of the devil. For we do not wrestle against flesh and blood, but against the rulers, against the authorities, against the cosmic powers over this present darkness, against the spiritual forces of evil in the heavenly places. Therefore take up the whole armor of God, that you may be able to withstand in the evil day, and having done all, to stand firm. Stand therefore, having fastened on the belt of truth, and having put on the breastplate of righteousness, ...

For since the message declared by angels proved to be reliable, and every transgression or disobedience received a just retribution, how shall we escape if we neglect such a great salvation? It was declared at first by the Lord, and it was attested to us by those who heard, while God also bore witness by signs and wonders and various miracles and by gifts of the Holy Spirit distributed according to his will.

Be sober-minded; be watchful. Your adversary the devil prowls around like a roaring lion, seeking someone to devour. Resist him, firm in your faith, knowing that the same kinds of suffering are being experienced by your brotherhood throughout the world.

Whoever confesses that Jesus is the Son of God, God abides in him, and he in God.

By this we know that we abide in him and he in us, because he has given us of his Spirit.

Do not love the world or the things in the world. If anyone loves the world, the love of the Father is not in him. For all that is in the worldthe desires of the flesh and the desires of the eyes and pride in possessionsis not from the Father but is from the world.

Those who are in the flesh cannot please God. You, however, are not in the flesh but in the Spirit, if in fact the Spirit of God dwells in you. Anyone who does not have the Spirit of Christ does not belong to him.

So that we may no longer be children, tossed to and fro by the waves and carried about by every wind of doctrine, by human cunning, by craftiness in deceitful schemes.

You are to deliver this man to Satan for the destruction of the flesh, so that his spirit may be saved in the day of the Lord.

Do not deprive one another, except perhaps by agreement for a limited time, that you may devote yourselves to prayer; but then come together again, so that Satan may not tempt you because of your lack of self-control.

Therefore God gave them up in the lusts of their hearts to impurity, to the dishonoring of their bodies among themselves, because they exchanged the truth about God for a lie and worshiped and served the creature rather than the Creator, who is blessed forever! Amen. For this reason God gave them up to dishonorable passions. For their women exchanged natural relations for those that are contrary to nature; and the men likewise gave up natural relations with women and were consumed with passion for one another, men committing shameless acts with men and receiving in themselves the due penalty for their error. And since they did not see fit to acknowledge God, God gave them up to a debased mind to do what ought not to be done. ...

Go to this people, and say, You will indeed hear but never understand, and you will indeed see but never perceive. For this people's heart has grown dull, and with their ears they can barely hear, and their eyes they have closed; lest they should see with their eyes and hear with their ears and understand with their heart and turn, and I would heal them.

Simon Peter answered him, Lord, to whom shall we go? You have the words of eternal life, and we have believed, and have come to know, that you are the Holy One of God.

If you love me, you will keep my commandments. And I will ask the Father, and he will give you another Helper, to be with you forever, even the Spirit of truth, whom the world cannot receive, because it neither sees him nor knows him. You know him, for he dwells with you and will be in you.

And since they did not see fit to acknowledge God, God gave them up to a debased mind to do what ought not to be done. They were filled with all manner of unrighteousness, evil, covetousness, malice. They are full of envy, murder, strife, deceit, maliciousness. They are gossips, slanderers, haters of God, insolent, haughty, boastful, inventors of evil, disobedient to parents, foolish, faithless, heartless, ruthless. Though they know God's decree that those who practice such things deserve to die, they not only do them but give approval to those who practice them.

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What Does the Bible Say About Spiritual Blindness?

For the last decade now we have been promised the advent of dental stem cell therapy to help regrow our missing teeth. With the growth and expansion of newer technologies like dental implants, and advances in root canal therapy, the talk of stem cells has subtly taken a back seat. The question remains: how far away are we from stem cells actually impacting the dental market?

Sungtao Shi, professor and chairman at the University of Pennsylvania department of Anatomy and Cell Biology, is at the forefront of this research and he is showing how close we may actually be to this new form of treatment.

Professor Shi has been working for the past ten years testing the possibilities of dental stem cells after discovering them in his own childs baby tooth. His team has learned more about how these dental stem cells work, and how they could be safely be used to regrow dental tissue, known as pulp (this is the tissue that we see within our teeth).

Dental Stem Cell Therapy

Shi along with David Mooney (Professor of Bioengineering at Harvard University) are making claims that these stem cells can be directly placed within our dental pulp to help regrow parts of a tooth that have been damaged by decay.

Several other researchers have also chimed in getting similar results in their own laboratories. Paul Sharpe, a leading bioengineer at Kings County London, has noted that his lab findings indicate mobilizing dental stem cells into our own pulp helps regrow lost dentin. He claims that the new dentin that is formed completely fuses with our own healthy dentin.

Sharpe has also add that this form of tissue engineering could be the first real advance in dental pharmaceuticals, and that we could see this on the market very soon.

The question that this form of therapy poses is this: how much of these stem cells need to be synthesized and given to each individual? The amount will be critical as too much may lead to serious side effects in people. Clinical trials will need to be conducted to see what amount of the agent is safe.

Sharpe is now investigating larger groups of potential agents to determine which stem cell therapy works best for decaying teeth and also working on the optimal dose.

Sharpes team is also working on a new delivery system, which is more practical to modern dental clinics: The chosen agent of stem cells will be dissolved in gel-form, and is injected directly into a cavity and bathed with ultraviolet light until it has solidified. This is a quick and easy procedure for any trained dentist.

Dental Stem Cells

The hope is to properly introduce newer stem cell treatments into modern dentistry, although, researchers still need to perform clinical trials with human patients for efficacy and safety standards.

Some of the dental stem cell treatments are currently being considered to be approved for other uses in humans, which he hopes will expedite the process for eventual FDA approval. A lot of dental treatments are still in the dark ages, Sharpe says. Its time to move forward.

We find ourselves in a revolutionary time in the field of dentistry. Over the next decade we will hopefully see newer agents like these enter the market and make a significant impact on our communities. This new stem cell technology will hopefully also reduce the sky-rocketing prices of certain other dental procedures.

Ultimately, we will have to wait and see how quickly clinical trials move forward, and how efficacious these agents are on a mass scale.

Best Dental with Dr. Jasmine Naderi

Excerpt from:
Dental Stem Cell Therapy with Dr. Jasmine Naderi, DDS

The latest Part of the Journal of Law and Medicine includes the following sections: Editorial: Doctors Suing Patients: Wrestling with Doing No Harm Ian Freckelton QC; Legal Issues: Supporting People with Decision-Making Impairments: Choice, Control and Consumer Transactions Yvette Maker, Bernadette McSherry, Lisa Brophy, Jeannie Marie Paterson and Anna Arstein-Kerslake; Medical Issues: Novel Psychoactive Substances: The Challenges for Health Care, Analytical Science and the Law Victoria Bicknell, Dimitri Gerostamoulos and David Ranson; Bioethical Issues: Taking the Moral Measure of Mental Capacity: Interpretation and Implementation Grant Gillett; and Medical Law Reporter: Public Health Legislation Prohibiting Sports-Embedded Gambling Advertisting Madeleine Farrar and Thomas Faunce.Also in this Part are the following articles: Complementary Health Practitioners Disciplined for Misconduct in Australia 2010-2016 Jenni Millbank, Miranda Kaye, Anita Stuhmcke, David Sibbritt, Isabel Karpin and Jon Wardle; Professional Discipline of the New Zealand Nursing Residential Care Workforce: A Mixed Methods Analysis of HPDT Decisions 2004-2014 Kate Kersey, Kate Diesfeld, Lois J Surgenor and Michael Ip; The Legal System and the Legitimacy of Clinical Guidelines Fiona McDonald; Wastewater Analysis of Substance Use: Implications for Law, Policy and Research Jeremy Prichard, Foon Yin Lai, Emma van Dyken, Phong Thai, Raimondo Bruno, Wayne Hall, Paul Kirkbride, Coral Gartner, Jake OBrien and Jochen F Mueller; Abortion Law in New South Wales: Shifting from Criminalisation to the Recognition of the Reproductive Rights of Women and Girls Christine Forster and Vedna Jivan; Proprietary Rights in Stored Semen: Roblin v Public Trustee and the Commonsense Approach to Stored Human Tissue of Significance Madeline Baker; Treatment of Intersex Children as a Special Medical Procedure Skye ODwyer; Life on the Liminal Bridge Spanning Fertility and Infertility: A Time to Dream and a Time to Decide Pamela M White; Coercive Community Treatment in Mental Health: An Idea Whose Time Has Passed? Sascha Callaghan and Giles Newton-Howes; Blood Libel: An Analysis of Blood Donation Policy As It Affects Gay Men in Australia Edward Davis; Stigma, Homosexuality and the Homosexual Advance Defence Anthony Gray and Kerstin Braun; and The Role of Legal Proxies in End-of-Life Decisions in Italy: A Comparison with Other Western European Countries Denard Veshi and Gerald Neitzke. There are also reviews of the books Patients with Passports: Medical Tourism, Law and Ethics by I Glenn Cohen reviewed by Ian Freckelton QC; and Stem Cell Tourism and the Political Economy of Hope by Alan Petersen, Megan Munsie, Claire Tanner, Casimir MacGregor and Jane Brophy reviewed by Ian Freckelton QC.

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Stem Cell Tourism and the Political Economy of Hope

By Gene Bruno, MS, MHS Dean of Academics, Huntington College of Health Sciences. Colostrum, known as an immune modulator and also for its growth factors, is beneficial in the treatment of autoimmune diseases, viruses, allergies, leaky gut syndrome, and wound healing.Colostrum Informed Opinion Colostrum is the first milk

Hannu Korhonen1 *, P. Marnila1 and H. S. Gill Agricultural Research Centre of Finland, Food Research, FIN-31600 Jokioinen, Finland Milk and Health Research Centre, Massey University and New Zealand Dairy Research Institute, Private Bag 11 222, Palmerston North, New Zealand The immunoglobulins of bovine colostrum provide the major antimicrobial protection

There has been a lot of press recently about gastric bleeding from numerous prescription drugs, especially the anti-inflammatory group including Aspirin, Celebrex, Motrin, etc. Our delicate intestinal lining actually develops tears or lesions and then undigested food particles enter the bloodstream. These substances are recognized as offenders and so the

Abstract: Immune Function after exercise Strenuous and/or prolonged exercise causes transient perturbations in immune function. It is well accepted that this is one mechanism contributing to the higher occurrence of infection (e.g. upper respiratory tract infection (URTI)) in athletes, especially endurance athletes. URTI or upper respiratory tract (URT) symptoms can

Bovine Colostrum Supplementation:Secretory IgA in saliva (s-IgA) is a potential mucosal immune correlate of upper respiratory tract infection (URTI) status. Nutritional supplements may improve mucosal immunity, and could be beneficial to athletes who are at increased risk of URTI. In this study, 35 distance runners (15 female, 20 male, age

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immune system Archives - Colostrum Science

The topic may be fraught with questions and misconceptions, but its important to discuss the pros and cons ofstem cell therapy. Why are some people against stem cell research? What are the possible benefits of stem cell therapy in the field of regenerative treatment? When balancing an ethical debate, its important to weigh facts.

There have been some controversies surrounding the procedures involved in stem cell therapy. However, most of the criticism surrounding this research is related to human embryonic stem cells: the ethical questionability of acquisition, and the surrounding issues about donation consent.

Embryonic stem cells (ES) have important qualities for a successful stem cell therapy: pluripotency, unlimited capability for self-renewal, and a huge potential when it comes to the field of transplantation and tissue engineering. However, embryonic cells are acquired from the inner mass of cells of a blastocyst: an early-stage, pre-implantation human embryo. The controversy then is the isolation of the ES and how it results in the destruction of human embryos. Some people see the destruction of the blastocysts as equal to the destruction of an unborn human life, while others argue that the embryo is not exactly a human being yet.

Stem cell research is a relatively new field: the first occurrence of the term stem cell in scientific literature was in 1868, when Ernst Haeckel, a German biologist used it to describe the fertilized egg that eventually becomes an organism. In 2001, President George W. Bush signed an order authorizing the use of federal funding for a limited number of cell lines. Additionally, as with any new technology or research field, the long-term effects of stem cell therapy has not yet been examined.

Multipotency is one of the most important characteristics of stem cells to be effective in treatment. On the other hand, adult stem cells, which are non-embryonic stem cells, carry the risk of unipotency. Therefore the adult cells could be pre-specialized, and create only particular progeny. Neural stem cells run the risk of producing only brain cells, greatly limiting the regenerative potential for patients with Alzheimers and Parkinsons disease.

In spite of the cons, stem cell research is a more than a promising field of medical research. Its being eyed as a possible solution for diseases that are currently incurable. This is due to the fact that stem cell transplants and research explores one foundational human interest: the human bodys amazing capability to repair and heal itself.

Stem cell research is a powerhouse in the fields of therapeutic cloning, regenerative medicine, drug development/testing, and organ development and transplant. It will also shed light on previously unexamined aspects of early human development. All of which can potentially help in the prevention of birth defects, infertility, and miscarriages. Stem cell research will bring forth an era of enlightenment in terms of human growth.

Stem cell research will usher in a brand new understanding of human physiological functions, resulting in a surge of medical advancements. It could also introduce prevention and/or cure for degenerative diseases. Some of the diseases which may be reversible through advancements in the field of stem cell research include:

Adult stem cells hold the key to the bodys self-repair mechanism. Adult cells are mesenchymal stem cells and pluripotent stem cells which have advanced the use of stem cell therapy to reverse aging. Additionally, through the repair or replacement of worn organs, the length and quality of human life have the chance to improve.

Here are some of the advancements by scientists in the field of stem cell research, delivered by Wall Street Journal!

Stem cell research has been through a number of debates and assessments based on the pros and cons of stem cell therapy. However, this hasnt stopped scientists to research its potential. Whatever your stance may be when it comes to stem cell research, its important to consider the possibilities this research holds. Find the nearest research center or laboratory and ask around for more information!

Do you have questions about stem cell research? Whats your stance on embryonic stem cell research? Share your thoughts in the comments box below!

Up Next:Umbilical Cord Blood Stem Cells Pros and Cons

Editors Note This post was originally published on November 2, 2017 and has been updated for quality and relevancy.

Pros And Cons of Stem Cell Therapy

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Pros And Cons of Stem Cell Therapy | Stem Cell Researchers

Stem Cell Therapy in Florida, Stem Cell Treatment Florida | Stemedix

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I just want to say thanks to everyone who was involved, the nurses, the doctors It was an amazing treatment.

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Bottom line, we are very well pleased. If someone were to ask me I would tell them, "go for it".

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It is difficult to find any issue with the organization, the set up, or the procedure itself...very pleased.

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Thank you so much for being so amazing to work with. I am already noticing some results from my first treatment and am looking forward to my next procedure!

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"I was totally satisfied with the experience! After the procedure my tremors subsided and could stand much better."

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Aging is a complex process that our bodies experience as we grow older. The process of aging involves every cell and organ to undergo a steady rate of deterioration.

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ALS is one of the muscle conditions in the muscular dystrophy spectrum.It stands for Amyotrophic Lateral Sclerosis, but it is more commonly known as Lou Gehrigs Disease.

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Alzheimers Disease (AD) is a form of dementia which causes memory loss and can inhibit intellectual abilities severely enough to interfere with a persons daily activities.

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CFS also known as chronic fatigue immune dysfunction syndrome (CFIDS) and myalgic encephalomyelitis (ME) is a complicated disorder that is not relieved by sleeping or resting and is progressive.

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One of the most common lung diseases COPD refers to a group of lung conditions that make it difficult tobreathe by blocking the airflow in and out of the lungs; emphysema, chronic bronchitis, and chronic asthma.

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Lupus is an autoimmune disease in which ones immune system becomes hyperactive and attacks healthy, normal living tissue. There are many kinds of lupus with varying symptoms.

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MS is a degenerative disease in which the central nervous system (CNS) is attacked by an abnormal immune response causing inflammation and exposure of nerve fibers.

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The chronic disease Osteoarthritis (OA) is characterized by the breakdown of cartilage. As the cartilage in jointsof the body deteriorate, bones begin to rub against one another.

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Parkinson's is known as a progressive disease in which brain cell damage worsens and/or spreads over periods of time. The rate of progression is unique to each patient with symptoms varying...

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Rheumatoid Arthritis (RA) is an inflammatory autoimmune disease of which an individuals musculoskeletal system is compromised by and abnormal immune response.

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Sports and Regenerative Medicine is a catch all term for a variety of different conditions. Sports medicine started with the treatment of the musculoskeletal injuries that occurred while engaging in athletics...

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MESSAGE FROM CONFERENCE CHAIRS

WELCOME to Sydney Australia for the 10th International Nanomedicine Conference.

The annual International Nanomedicine Conference is regarded as the most significant nanomedicine meeting in the Southern Hemisphere.This event attracts approx. 250 registrants with representation from academia, medical research institutes and biotech companies. More than half of the delegates are from interstate and international organisations.

2019 marks the 10th Anniversary of this very successful conference. The Conference will be held from 24-26 June 2019 at Pier One Sydney Harbour Hotel for a special 10th Anniversary celebration. This event is again brought to you by the Australian Centre for NanoMedicine (ACN) and the ARC Centre of Excellence in Convergent Bio-Nano Science and Technology (CBNS). The main objective of the conference is to share novel research that may lead to prevention, diagnosis and/or treatment of some of the most challenging diseases,in an environment conducive to networking with colleagues from around the world.

We are fortunate to have five prominent scholars as our Plenary Speakers Professors Joe Wang, Milica Radisic, Chunying Chen, Ranjeny Thomas and Alan Rowan who will lead us through an exploration of our conference themes.

We will also showcase 15 Keynote speakers and 20 Invited speakers who will head discussions in the conference theme areasof Sensors and Imaging, Drug Delivery, Bioactive Materials, Social Aspects & Regulatory, Bio-Nano Interactions & Nanotoxicology, Industry Session and Microfluidic & Bioengineered Models. The unique Clinical Challenges session brings medical doctors into the conference to discuss opportunities for improving the treatment of patients in the clinic.

On behalf of the Conference Organising Committee, we look forward to welcoming you to the Conference!

Scientia Professor Justin Gooding

Professor Maria Kavallaris

Professor Tom Davis

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10th International Nanomedicine Conference 24-26 June ...

Profile

Welcome to New Medicine Stem Cell Clinic

New Medicine Stem Cell Clinic, located in Moscow, Russia, has been among the first centers in this country to use the innovative stem cell therapy for prevention, and rehabilitation, as well as for organism revitalization and rejuvenation.

The mesenchymal stem cells (MSCs) are stem cells that have been harvested from mesenchymal tissues, such as cartilage, bones, derma and connective tissue. These cells have the ability to differentiate into various cell types.

MSCs fulfill three groups of tasks:

Stem cells (SCs) are able to divide asymmetrically, leading to self-renewal and their ability to turn into specialized cells of any organ and tissue.

The New Medicine clinic uses the following stem cells for therapy:

Range of diseases that may be treated successfully with stem cells

Cardiological diseases

Vascular diseases

Endocrine system diseases

Nervous System Diseases

Hereditary diseases

Ophthalmic diseases

Hepatic diseases

Gastrointestinal diseases

Respiratory diseases

Diseases of genitourinary system

Musculoskeletal System Diseases

Skin diseases

Revitalization

Why choose us?

If you want to find out more about the treatments and procedures offered by New Medicine Stem Cell Clinic, please contact us!

Originally posted here:
New Medicine Stem Cell Clinic in Moscow, Russia

This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

PRIMARY OBJECTIVES:

I. To compare overall survival in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative first remission who undergo autologous hematopoietic stem cell transplantation (auto-HCT) followed by maintenance rituximab versus (vs.) maintenance rituximab alone (without auto-HCT).

SECONDARY OBJECTIVES:

I. To compare progression-free survival in MCL patients in MRD-negative first remission who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone.

II. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive (or MRD-indeterminate) patients who undergo auto-HCT followed by 2 years of maintenance rituximab.

III. To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT.

IV. To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive prior to auto-HCT.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab intravenously (IV) once every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I.

After completion of study treatment, patients are followed up every 3 and 6 months for 10 years.

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Rituximab With or Without Stem Cell Transplant in Treating ...

LONDON (Reuters) - Stem-cell tourism involving patients who travel to developing countries for treatment with unproven and potentially risky therapies should be more tightly regulated, international health experts said on Wednesday.

With hundreds of medical centers around the world claiming to be able to repair damaged tissue in conditions such as multiple sclerosis and Parkinson's disease, tackling unscrupulous advertising of such procedures is crucial.

These therapies are advertised directly to patients with the promise of a cure, but there is often little or no evidence to show they will help, or that they will not cause harm, the 15 experts wrote in the journal Science Translational Medicine.

Some types of stem cell transplant mainly using blood and skin stem cells have been approved by regulators after full clinical trials found they could treat certain types of cancer and grow skin grafts for burns patients.

But many other potential therapies are only in the earliest stages of development and have not been approved by international regulators.

"Stem cell therapies hold a lot of promise, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments," said one of the 15, Sarah Chan of Britain's University of Edinburgh.

The experts called for global action, led by the World Health Organization, to introduce controls on advertising and agree international standards for the manufacture and testing of cell and tissue-based therapies.

"The globalization of health markets and the specific tensions surrounding stem cell research and its applications

have made this a difficult challenge," they wrote. "However, the stakes are too high not to take a united stance."

(Reporting by Kate Kelland, editing by John Stonestreet)

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'Stem-cell tourism' needs tighter controls, say medical ...

Consumer awareness of personalized medicine is up 4% from 2018, according to a new report from Dosis, an AI-powered personalized dosing platform. The 2019 Dosis Personalized and Digital Medicine Consumer Report surveyed more than 1,000 consumers, weighted for the U.S. population, to gain a better understanding of how big the disconnect is between the advances in personalized medicine approaches and general consumer awareness of its benefits.

Consumer Awareness of Personalized Medicine Continues to be Slow

While the report found consumer awareness of personalized medicine has risen to 33% in 2019 from 29% in 2018, the progress with educating patients on the improvements in care that it can bring, along with the treatments associated with its practice, continues to be slow. In fact, consumer awareness has only grown by around 1% year-over-year since 2013.

Somewhat surprisingly, those 65+ were the most likely (37%) to be familiar with personalized medicine. Its often believed that elderly patients are reluctant to try new technologies or innovative alternatives to traditional medicine, but its also true that they are the age group most likely to be dealing with some type of healthcare issue.

Additionally, the earliest uses of personalized medicine have been in oncology, and one-quarter of new cancer cases are diagnosed in people aged 65 to 74. As these older patients are spending more time within care facilities and with their primary care provider than younger adults, its likely that theyve become more familiar with the potential for medicine personalized to address unique health ailments.

Familiarity with Personalized Medicine Increases Patient Interest in It

To find out if unfamiliarity with personalized medicine leads to less interest in using it as a treatment option, we provided respondents with this definition of personalized medicine after their initial familiarity responses: A medical treatment determined to be best for you based on your unique predicted response or risk of disease.

Respondents were asked if they would be interested in personalized medicine options defined in this way. Of the subset of consumers that previously noted they had familiarity with personalized medicine, nearly half (49%) said they were interested in personalized medicine under this definition. Comparatively, of those that said they were previously unaware of personalized medicine only 22% noted they would be interested in personalized medicine with this definition.

Patients Need to Be Educated on Personalized Medicine

Clearly, simply defining personalized medicine is not enough to get consumers to jump on the idea of using it for their future treatments. This is just further proof that patients need to be educated on personalized medicine, as well as the broader notion that they are different in their own way from any other patient over a period of time. Many consumers will still need to be walked through how their unique complement of genes, lifestyle and environmental factors should be considered when creating the best treatment plan for them.

Other key findings from the report include:

60% of those tracking data willing to share it with their healthcare provider to improve their health; however, only 14% said they would be willing to share their data with a provider to specifically influence personalized treatment.

Generation Z (18-24-year-olds) were the most likely (17%) to say they would be willing to share their tracked data with their providers to gain access to more personalized treatments.

Respondents wereasked consumers if they have taken a direct-to-consumer DNA or Gene Test with the specific goal of sharing with their provider to inform their treatment plan. Nearly 6% of consumers indicated that they took a test with that direct aim in mind, meaning that may be a top driver of interest in taking these at-home test.

Only 24% of consumers said they would be willing to take a diagnostic test for access to personalized medicine treatments.

So would consumers opt for a personalized treatment outside their insurance coverage if they were confronted with a serious condition? 32% of consumers said they would seek personalized medicine alternatives for a serious condition, but there are financial limits. Nearly two-thirds of that 32% said they would stop pursuing personalized medicine alternatives for a serious condition if treatments were priced more than their annual deductible.

Impact of Findings

As more consumers are educated on how their genetic makeup, lifestyle and environmental factors uniquely affect their medical treatments, I believe both awareness of and interest in personalized medicine will continue to grow, said Shivrat Chhabra, Founder & CEO of Dosis. Younger patients have expressed growing dissatisfaction with traditional care, and the findings of our report indicate that their interest in technology may be a major opportunity to further their awareness in personalized medicine alternatives.

See the article here:
Consumer Awareness of Personalized Medicine Has Only Grown by ...

Abstract

Polygenic Risk Scores (PRS) combine genotype information across many single-nucleotide polymorphisms (SNPs) to give a score reflecting the genetic risk of developing a disease. PRS might have a major impact on public health, possibly allowing for screening campaigns to identify high-genetic risk individuals for a given disease. The Clumping+Thresholding (C+T) approach is the most common method to derive PRS. C+T uses only univariate genome-wide association studies (GWAS) summary statistics, which makes it fast and easy to use. However, previous work showed that jointly estimating SNP effects for computing PRS has the potential to significantly improve the predictive performance of PRS as compared to C+T. In this paper, we present an efficient method for the joint estimation of SNP effects using individual-level data, allowing for practical application of penalized logistic regression (PLR) on modern datasets including hundreds of thousands of individuals. Moreover, our implementation of PLR directly includes automatic choices for hyper-parameters. We also provide an implementation of penalized linear regression for quantitative traits. We compare the performance of PLR, C+T and a derivation of random forests using both real and simulated data. Overall, we find that PLR achieves equal or higher predictive performance than C+T in most scenarios considered, while being scalable to biobank data. In particular, we find that improvement in predictive performance is more pronounced when there are few effects located in nearby genomic regions with correlated SNPs; for instance, in simulations, AUC values increase from 83% with the best prediction of C+T to 92.5% with PLR. We confirm these results in a data analysis of a case-control study for celiac disease where PLR and the standard C+T method achieve AUC values of 89% and of 82.5%. Applying penalized linear regression to 350,000 individuals of the UK Biobank, we predict height with a larger correlation than with the best prediction of C+T (65% instead of 55%), further demonstrating its scalability and strong predictive power, even for highly polygenic traits. Moreover, using 150,000 individuals of the UK Biobank, we are able to predict breast cancer better than C+T, fitting PLR in a few minutes only. In conclusion, this paper demonstrates the feasibility and relevance of using penalized regression for PRS computation when large individual-level datasets are available, thanks to the efficient implementation available in our R package bigstatsr.

POLYGENIC risk scores (PRS) combine genotype information across many single-nucleotide polymorphisms (SNPs) to give a score reflecting the genetic risk of developing a disease. PRS are useful for genetic epidemiology when testing polygenicity of diseases and finding a common genetic contribution between two diseases (Purcell et al. 2009). Personalized medicine is another major application of PRS. Personalized medicine envisions to use PRS in screening campaigns in order to identify high-risk individuals for a given disease (Chatterjee et al. 2016). As an example of practical application, targeting screening of men at higher polygenic risk could reduce the problem of overdiagnosis and lead to a better benefit-to-harm balance in screening for prostate cancer (Pashayan et al. 2015). However, in order to be used in clinical settings, PRS should discriminate well enough between cases and controls. For screening high-risk individuals and for presymptomatic diagnosis of the general population, it is suggested that, for a 10% disease prevalence, the AUC must be >75% and 99%, respectively (Janssens et al. 2007).

Several methods have been developed to predict disease status, or any phenotype, based on SNP information. A commonly used method often called P+T or C+T (which stands for Clumping and Thresholding) is used to derive PRS from results of Genome-Wide Association Studies (GWAS) (Wray et al. 2007; Evans et al. 2009; Purcell et al. 2009; Chatterjee et al. 2013; Dudbridge 2013). This technique uses GWAS summary statistics, allowing for a fast implementation of C+T. However, C+T also has several limitations; for instance, previous studies have shown that predictive performance of C+T is very sensitive to the threshold of inclusion of SNPs, depending on the disease architecture (Ware et al. 2017). In parallel, statistical learning methods have also been used to derive PRS for complex human diseases by jointly estimating SNP effects. Such methods include joint logistic regression, Support Vector Machine (SVM) and random forests (Wei et al. 2009; Abraham et al. 2012, 2014; Botta et al. 2014; Okser et al. 2014; Lello et al. 2018; Mavaddat et al. 2019). Finally, Linear Mixed-Models (LMMs) are another widely used method in fields such as plant and animal breeding, or for predicting highly polygenic quantitative human phenotypes such as height (Yang et al. 2010). Yet, predictions resulting from LMM, known e.g., as gBLUP, have not proven as efficient as other methods for predicting several complex diseases based on genotypes [see table 2 of Abraham et al. (2013)].

We recently developed two R packages, bigstatsr and bigsnpr, for efficiently analyzing large-scale genome-wide data (Priv et al. 2018). Package bigstatsr now includes an efficient algorithm with a new implementation for computing sparse linear and logistic regressions on huge datasets as large as the UK Biobank (Bycroft et al. 2018). In this paper, we present a comprehensive comparative study of our implementation of penalized logistic regression (PLR), which we compare to the C+T method and the T-Trees algorithm, a derivation of random forests that has shown high predictive performance (Botta et al. 2014). In this comparison, we do not include any LMM method, yet, L2-PLR should be very similar to LMM methods. Moreover, we do not include any SVM method because it is expected to give similar results to logistic regression (Abraham et al. 2012). For C+T, we report results for a large grid of hyper-parameters. For PLR, the choice of hyper-parameters is included in the algorithm so that we report only one model for each simulation. We also use a modified version of PLR in order to capture not only linear effects, but also recessive and dominant effects.

To perform simulations, we use real genotype data and simulate new phenotypes. In order to make our comparison as comprehensive as possible, we compare different disease architectures by varying the number, size and location of causal effects as well as disease heritability. We also compare two different models for simulating phenotypes, one with additive effects only, and one that combines additive, dominant and interaction-type effects. Overall, we find that PLR achieves higher predictive performance than C+T except in highly underpowered cases (AUC values lower than 0.6), while being scalable to biobank data.

We use real genotypes of European individuals from a case-control study for celiac disease (Dubois et al. 2010). This dataset is presented in Supplemental Material, Table S1. Details of quality control and imputation for this dataset are available in Priv et al. (2018). For simulations presented later, we first restrict this dataset to controls from UK in order to remove the genetic structure induced by the celiac disease status and population structure. This filtering process results in a sample of 7100 individuals (see supplemental notebook preprocessing). We also use this dataset for real data application, in this case keeping all 15,155 individuals (4496 cases and 10,659 controls). Both datasets contain 281,122 SNPs.

We simulate binary phenotypes using a Liability Threshold Model (LTM) with a prevalence of 30% (Falconer 1965). We vary simulation parameters in order to match a range of genetic architectures from low to high polygenicity. This is achieved by varying the number of causal variants and their location (30, 300, or 3000 anywhere in all 22 autosomal chromosomes or 30 in the HLA region of chromosome 6), and the disease heritability (50 or 80%). Liability scores are computed either from a model with additive effects only (ADD) or a more complex model that combines additive, dominant and interaction-type effects (COMP). For model ADD, we compute the liability score of the i-th individual aswhere is the set of causal SNPs, are weights generated from a Gaussian distribution or a Laplace distribution , is the allele count of individual i for SNP j, corresponds to its standardized version (zero mean and unit variance for all SNPs), and follows a Gaussian distribution . For model COMP, we simulate liability scores using additive, dominant and interaction-type effects (see Supplemental Materials).

We implement three different simulation scenarios, summarized in Table 1. Scenario N1 uses the whole dataset (all 22 autosomal chromosomes 281,122 SNPs) and a training set of size 6000. For each combination of the remaining parameters, results are based on 100 simulations except when comparing PLR with T-Trees, which relies on five simulations only because of a much higher computational burden of T-Trees as compared to other methods. Scenario N2 consists of 100 simulations per combination of parameters on a dataset composed of chromosome six only (18,941 SNPs). Reducing the number of SNPs increases the polygenicity (the proportion of causal SNPs) of the simulated models. Reducing the number of SNPs (p) is also equivalent to increasing the sample size (n) as predictive power increases as a function of (Dudbridge 2013; Vilhjlmsson et al. 2015). For this scenario, we use the additive model only, but continue to vary all other simulation parameters. Finally, scenario N3 uses the whole dataset as in scenario N1 while varying the size of the training set in order to assess how the sample size affects predictive performance of methods. A total of 100 simulations per combination of parameters are run using 300 causal SNPs randomly chosen on the genome.

In this study, we use two different measures of predictive accuracy. First, we use the Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) (Lusted 1971; Fawcett 2006). In the case of our study, the AUC is the probability that the PRS of a case is greater than the PRS of a control. This measure indicates the extent to which we can distinguish between cases and controls using PRS. As a second measure, we also report the partial AUC for specificities between 90 and 100% (McClish 1989; Dodd and Pepe 2003). This measure is similar to the AUC, but focuses on high specificities, which is the most useful part of the ROC curve in clinical settings. When reporting AUC results of simulations, we also report maximum achievable AUC values of 84% and 94% for heritabilities of 50% and 80%, respectively. These estimates are based on three different yet consistent estimations (see Supplemental Materials).

In this paper, we compare three different types of methods: the C+T method, T-Trees and PLR.

The C+T method directly derives PRS from the results of Genome-Wide Associations Studies (GWAS). In GWAS, a coefficient of regression (i.e., the estimated effect size ) is learned independently for each SNP j along with a corresponding P-value . The SNPs are first clumped (C) so that there remain only loci that are weakly correlated with one another (this set of SNPs is denoted ). Then, thresholding (T) consists in removing SNPs with P-values larger than a user-defined threshold . Finally, the PRS for individual i is defined as the sum of allele counts of the remaining SNPs weighted by the corresponding effect coefficientswhere are the effect sizes (P-values) learned from the GWAS. In this study, we mostly report scores for a clumping threshold at within regions of 500kb, but we also investigate thresholds of 0.05 and 0.8. We report three different scores of prediction: one including all the SNPs remaining after clumping (denoted C+T-all), one including only the SNPs remaining after clumping and that have a P-value under the GWAS threshold of significance (, C+T-stringent), and one that maximizes the AUC (C+T-max) for 102 P-value thresholds between 1 and (Table S2). As we report the optimal threshold based on the test set, the AUC for C+T-max is an upper bound of the AUC for the C+T method. Here, the GWAS part uses the training set while clumping uses the test set (all individuals not included in the training set).

T-Trees (Trees inside Trees) is an algorithm derived from random forests (Breiman 2001) that takes into account the correlation structure among the genetic markers implied by linkage disequilibrium (Botta et al. 2014). We use the same parameters as reported in table 4 of Botta et al. (2014), except that we use 100 trees instead of 1000. Using 1000 trees provides a minimal increase of AUC while requiring a disproportionately long processing time (e.g., AUC of 81.5% instead of 81%, data not shown).

Finally, for PLR, we find regression coefficients and that minimize the following regularized loss function(1)where , x denotes the genotypes and covariables (e.g., principal components), y is the disease status to predict, and are two regularization hyper-parameters that need to be chosen. Different regularizations can be used to prevent overfitting, among other benefits: the L2-regularization (ridge, Hoerl and Kennard (1970)) shrinks coefficients and is ideal if there are many predictors drawn from a Gaussian distribution (corresponds to in the previous equation); the L1-regularization (lasso, Tibshirani 1996) forces some of the coefficients to be equal to zero and can be used as a means of variable selection, leading to sparse models (corresponds to ); the L1- and L2-regularization (elastic-net, Zou and Hastie 2005) is a compromise between the two previous penalties and is particularly useful in the situation (p is the number of SNPs), or any situation involving many correlated predictors (corresponds to ) (Friedman et al. 2010). In this study, we use a grid search over . This grid-search is directly embedded in our PLR implementation for simplicity. Using should result in a model very similar to gBLUP.

To fit PLR, we use an efficient algorithm (Friedman et al. 2010; Tibshirani et al. 2012; Zeng and Breheny 2017) from which we derived our own implementation in R package bigstatsr. This algorithm builds predictions for many values of , which is called a regularization path. To obtain an algorithm that does not require to choose this hyper-parameter , we developed a procedure that we call Cross-Model Selection and Averaging (CMSA, Figure S1). Because of L1-regularization, the resulting vector of estimated effect sizes is sparse. We refer to this method as PLR in the results section.

To capture recessive and dominant effects on top of additive effects in PLR, we use simple feature engineering: we construct a separate dataset with three times as many variables as the initial one. For each SNP variable, we add two more variables coding for recessive and dominant effects: one variable is coded 1 if homozygous variant and 0 otherwise, and the other is coded 0 for homozygous referent and 1 otherwise. We then apply our PLR implementation to this dataset with three times as many variables as the initial one; we refer to this method as PLR3 in the rest of the paper.

We use Monte Carlo cross-validation to compute AUC, partial AUC, the number of predictors, and execution time for the original Celiac dataset with the observed case-control status: we randomly split 100 times the dataset in a training set of 12,000 individuals and a test set composed of the remaining 3155 individuals.

We compared PLR with the C+T method using simulations of scenario N1 (Table 1). When simulating a model with 30 causal SNPs and a heritability of 80%, PLR provides AUC of 93%, nearly reaching the maximum achievable AUC of 94% for this setting (Figure 1). Moreover, PLR consistently provides higher predictive performance than C+T across all scenarios considered, except in some cases of high polygenicity and small sample size, where all methods perform poorly (AUC values below 60% Figure 1 and Figure 3). PLR provides particularly higher predictive performance than C+T when there are correlations between predictors, i.e., when we choose causal SNPs to be in the HLA region. In this situation, the mean AUC reaches 92.5% for PLR and 84% for C+T-max (Figure 1). For the simulations, we do not report results in terms of partial AUC because partial AUC values have a Spearman correlation of 98% with the AUC results for all methods (Figure S3).

In practice, a particular value of the threshold of inclusion of SNPs should be chosen for the C+T method, and this choice can dramatically impact the predictive performance of C+T. For example, in a model with 30 causal SNPs, AUC ranges from <60% when using all SNPs passing clumping to 90% if choosing the optimal P-value threshold (Figure S4).

Concerning the threshold of the clumping step in C+T, we mostly used the common value of 0.2. Yet, using a more stringent value of 0.05 provides equal or higher predictive performance than using 0.2 in most of the cases we considered (Figure 2 and Figure 3).

Our implementation of PLR that automatically chooses hyper-parameter provides similar predictive performance than the best predictive performance of 100 models corresponding to different values of (Figure S8).

We tested the T-Trees method in scenario N1. As compared to PLR, T-Trees perform worse in terms of predictive ability, while taking much longer to run (Figure S5). Even for simulations with model COMP in which there are dominant and interaction-type effects that T-Trees should be able to handle, AUC is still lower when using T-Trees than when using PLR (Figure S5).

We also compared the two PLRs in scenario N1: PLR vs. PLR3 that uses additional features (variables) coding for recessive and dominant effects. Predictive performance of PLR3 are nearly as good as PLR when there are additive effects only (differences of AUC are always <2%) and can lead to significantly greater results when there are also dominant and interactions effects (Figures S6 and S7). For model COMP, PLR3 provides AUC values at least 3.5% higher than PLR, except when there are 3000 causal SNPs. Yet, PLR3 takes two to three times as much time to run and requires three times as much disk storage as PLR.

First, when reproducing simulations of scenario N1 using chromosome six only (scenario N2), the predictive performance of PLR always increase (Figure 2). There is a particularly large increase when simulating 3000 causal SNPs: AUC from PLR increases from 60% to nearly 80% for Gaussian effects and a disease heritability of 80%. On the contrary, when simulating only 30 or 300 causal SNPs with the corresponding dataset, AUC of C+T-max does not increase, and even decreases for a heritability of 80% (Figure 2). Second, when varying the training size (scenario N3), we report an increase of AUC with a larger training size, with a faster increase of AUC for PLR as compared to C+T-max (Figure 3).

Joint PLRs also provide higher AUC values for the Celiac data: 88.7% with PLR and 89.1% with PLR3 as compared to 82.5% with C+T-max (Figure S2 and Table 2). The relative increase in partial AUC, for specificities larger than 90%, is even larger (42 and 47%) with partial AUC values of 0.0411, 0.0426, and 0.0289 obtained with PLR, PLR3, and C+T-max, respectively. Moreover, logistic regressions use less predictors, respectively, at 1570, 2260, and 8360. In terms of computation time, we show that PLR, while learning jointly on all SNPs at once and testing four different values for hyper-parameter , is almost as fast as the C+T method (190 vs. 130 sec), and PLR3 takes less than twice as long as PLR (296 vs. 190 sec).

We tested our implementation on 656K genotyped SNPs of the UK Biobank, keeping only Caucasian individuals and removing related individuals (excluding the second individual in each pair with a kinship coefficient >0.08). Results are presented in Table 3.

Our implementation of L1-penalized linear regression runs in <1 day for 350K individuals (training set), achieving a correlation of >65.5% with true height for each sex in the remaining 24K individuals (test set). By comparison, the best C+T model achieves a correlation of 55% for women and 56% for men (in the test set), and the GWAS part takes 1 hr (for the training set). If using only the top 100,000 SNPs from a GWAS on the training set to fit our L1-PLR, correlation between predicted and true heights drops at 63.4% for women and 64.3% for men. Our L1-PLR on breast cancer runs in 13 min for 150K women, achieving an AUC of 0.598 in the remaining 39K women, while the best C+T model achieves an AUC of 0.589, and the GWAS part takes 15hr.

In this comparative study, we present a computationally efficient implementation of PLR. This model can be used to build PRS based on very large individual-level SNP datasets such as the UK biobank (Bycroft et al. 2018). In agreement with previous work (Abraham et al. 2013), we show that jointly estimating SNP effects has the potential to substantially improve predictive performance as compared to the standard C+T approach in which SNP effects are learned independently. PLR always outperforms the C+T method, except in some highly underpowered cases (AUC values always <0.6), and the benefits of using PLR are more pronounced with an increasing sample size or when causal SNPs are correlated with one another.

When there are many small effects and a small sample size, PLR performs worse than (the best result for) C+T. For example, this situation occurs when there are many causal variants (3K) to distinguish among many typed variants (280K) while using a small sample size (6K). In such underpowered scenarios, it is difficult to detect true causal variants, which makes PLR too conservative, whereas the best strategy is to include nearly all SNPs (Purcell et al. 2009).

When increasing sample size (scenario N3), PLR achieves higher predictive performance than C+T and the benefits of using PLR over C+T increase with an increasing sample size (Figure 3). Moreover, when decreasing the search space (total number of candidate SNPs) in scenario N2, we increase the proportion of causal variants and we virtually increase the sample size (Dudbridge 2013). In this scenario N2, even when there are small effects and a high polygenicity (3000 causal variants out of 18,941), PLR gets a large increase in predictive performance, now consistently higher than C+T (Figure 2).

The choice of hyper-parameter values is very important since it can greatly impact the performance of methods. In the C+T method, there are two main hyper-parameters: the and the thresholds that control how stringent are the C+T steps. For the clumping step, appropriately choosing the threshold is important. Indeed, on the one hand, choosing a low value for this threshold may discard informative SNPs that are correlated. On the other hand, when choosing a high value for this threshold, too much redundant information is included in the model, which adds noise to the PRS. Based on the simulations, we find that using a stringent threshold leads to higher predictive performance, even when causal SNPs are correlated. It means that, in most cases tested in this paper, avoiding redundant information in C+T is more important than including all causal SNPs. The choice of the threshold is also very important as it can greatly impact the predictive performance of the C+T method, which we confirm in this study (Ware et al. 2017). In this paper, we reported the maximum AUC of 102 different P-value thresholds, a threshold that should normally be learned on the training set only. To our knowledge, there is no clear standard on how to choose these two critical hyper-parameters for C+T. So, for C+T, we report the best AUC value on the test set, even if it leads to overoptimistic results for C+T as compared to PLR.

In contrast, for PLR, we developed an automatic procedure called CMSA that releases investigators from the burden of choosing hyper-parameter . Not only this procedure provides near-optimal results, but it also accelerates the model training thanks to the development of an early stopping criterion. Usually, cross-validation is used to choose hyper-parameter values and then the model is trained again with these particular hyper-parameter values (Hastie et al. 2008; Wei et al. 2013). Yet, performing cross-validation and retraining the model is computationally demanding; CMSA offers a less burdensome alternative. Concerning hyper-parameter that accounts for the relative importance of the L1 and L2 regularizations, we use a grid search directly embedded in the CMSA procedure.

We also explored how to capture nonlinear effects. For this, we introduced a simple feature engineering technique that enables PLR to detect and learn not only additive effects, but also dominant and recessive effects. This technique improves the predictive performance of PLR when there are nonlinear effects in the simulations, while providing nearly the same predictive performance when there are additive effects only. Moreover, it also improves predictive performance for the celiac disease.

Yet, this approach is not able to detect interaction-type effects. In order to capture interaction-type effects, we tested T-Trees, a method that is able to exploit SNP correlations and interactions thanks to special decision trees (Botta et al. 2014). However, predictive performance of T-Trees are consistently lower than with PLR, even when simulating a model with dominant and interaction-type effects that T-Trees should be able to handle.

The computation time of our PLR implementation mainly depends on the sample size and the number of candidate variables (variables that are included in the gradient descent). Indeed, the algorithm is composed of two steps: first, for each variable, the algorithm computes an univariate statistic that is used to decide if the variable is included in the model (for each value of ). This first step is very fast. Then, the algorithm iterates over a regularization path of decreasing values of , which progressively enables variables to enter the model (Figure S1). In the second step, the number of variables increases and computations stop when an early stopping criterion is reached (when prediction is getting worse on the corresponding validation set, see Figure S1).

For highly polygenic traits such as height and when using huge datasets such as the UK Biobank, the algorithm might iterate over >100,000 variables, which is computationally demanding. On the contrary, for traits like celiac disease or breast cancer that are less polygenic, the number of variables included in the model is much smaller so that fitting is very fast (only 13min for 150K women of the UK Biobank for breast cancer).

Memory requirements are tightly linked to computation time. Indeed, variables are accessed in memory thanks to memory-mapping when they are used (Priv et al. 2018). When there is not enough memory left, the operating system (OS) frees some memory for new incoming variables. Yet, if too many variables are used in the gradient descent, the OS would regularly swap memory between disk and RAM, severely slowing down computations. A possible approach to reduce computational burden is to apply penalized regression on a subset of SNPs by prioritizing SNPs using univariate tests (GWAS computed from the same dataset). Yet, this strategy was shown to reduce predictive power (Abraham et al. 2013; Lello et al. 2018), which we also confirm in this paper. Indeed, when using only the 100K most significantly associated SNPs, correlation between predicted and true heights is reduced from 0.656/0.657 to 0.634/0.643 within women/men. A key advantage of our implementation of PLR is that prior filtering of variables is no more required for computational feasibility, thanks to the use of sequential strong rules and early stopping criteria.

Our approach has one major limitation: the main advantage of the C+T method is its direct applicability to summary statistics, allowing to leverage the largest GWAS results to date, even when individual cohort data cannot be merged because of practical or legal reasons. Our implementation of PLR does not allow yet for the analysis of summary data, but this represents an important future direction. The current version is of particular interest for the analysis of modern individual-level datasets including hundreds of thousands of individuals.

Finally, in this comparative study, we did not consider the problem of population structure (Vilhjlmsson et al. 2015; Mrquez-Luna et al. 2017; Martin et al. 2017), and also did not consider nongenetic data such as environmental and clinical data (Van Vliet et al. 2012; Dey et al. 2013).

In this comparative study, we have presented a computationally efficient implementation of PLR that can be used to predict disease status based on genotypes. A similar penalized linear regression for quantitative traits is also available in R package bigstatsr. Our approach solves the dramatic memory and computational burdens faced by standard implementations, thus allowing for the analysis of large-scale datasets such as the UK biobank (Bycroft et al. 2018).

We also demonstrated in simulations and real datasets that our implementation of penalized regressions is highly effective over a broad range of disease architectures. It can be appropriate for predicting autoimmune diseases with a few strong effects (e.g., celiac disease), as well as highly polygenic traits (e.g., standing height) provided that sample size is not too small. Finally, PLR as implemented in bigstatsr can also be used to predict phenotypes based on other omics data, since our implementation is not specific to genotype data.

We are grateful to Flix Balazard for useful discussions about T-Trees, and to Yaohui Zeng for useful discussions about R package biglasso. We are grateful to the two anonymous reviewers who contributed to improving this paper. The authors acknowledge LabEx Pervasive Systems and Algorithms (PERSYVAL)-Lab [Agence Nationale de Recherche (ANR)-11-LABX-0025-01] and ANR project French Regional Origins in Genetics for Health (FROGH) (ANR-16-CE12-0033). The authors also acknowledge the Grenoble Alpes Data Institute, which is supported by the French National Research Agency under the Investissements davenir program (ANR-15-IDEX-02). This research was conducted using the UK Biobank Resource under Application Number 25589.

Available freely online through the author-supported open access option.

This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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April 30, 2019

Children born with a rare genetic disorder called X-linked severe combined immunodeficiency (X-SCID) dont have a functioning immune system. As a result, they cant fight off infections. Without treatment, an infant with X-SCID will usually die within the first year or two of life.

The best option for treatment of newly diagnosed infants with X-SCID has been stem-cell transplantation from a genetically matched sibling. But less than a quarter of children with X-SCID have a matched donor available. For those without a matched donor, standard treatment has been a half-matched bone marrow transplant from a parent. But most infants receiving this type of transplant only have part of their immune system, called T lymphocytes, restored. These infants will need lifelong injections of protective antibodies. In addition, as they grow into young adulthood, they may have chronic medical problems that affect growth, nutrition, and quality of life.

To develop a better approach to fix the immune systems of children with X-SCID, researchers have used gene therapy to alter patients own blood stem cells. An engineered virus brings a healthy copy of the gene into the stem cells to replace the mutated gene that causes the disease.

Early results from trials of gene therapy for X-SCID resulted in life-saving correction of T lymphocytes. But similar to bone marrow transplant from a parent, the immune restoration was incomplete. In addition, in those first gene therapy studies, almosta third of the children developed leukemia. The approach accidentally stimulated cells to grow uncontrollably. In later studies, improved design of the engineered virus didnt cause cancer, but also didnt fully restore a healthy immune system.

In 2010, Dr. Harry Malech of NIHs National Institute of Allergy and Infectious Diseases (NIAID) and Dr. Brian Sorrentino of St. Jude Childrens Research Hospital reported a new and safer version of gene therapy for X-SCID. They designed a harmless engineered virus (called a lentivector) that could deliver genes into cells without activating other genes that can cause cancer. Before the altered stem cells were returned to their bodies, patients were given low doses of the chemotherapy drug busulfan. This made it easier for the new stem cells to grow in the bone marrow. In young adults and children treated at the NIH Clinical Center, the new therapy proved to be both safe and effective at restoring the full range of immune functions.

Based on this work, a team led by Dr. Ewelina Mamcarz of St. Jude Childrens Research Hospital began treatment in 2015 of newly diagnosed infants with X-SCID using the lentivector and busulfan. The work was funded in part by NHLBI. The team described the treatment of eight infants with the disorder on April 18, 2019, in the New England Journal of Medicine.

By 3 to 4 months after infusion of the repaired stem cells, 7 of the 8 infants had normal levels of multiple types of immune cells in their blood. The last infant required a second stem-cell infusion, after which his immune-cell levels rose to a normal range.

The infants new immune systems were able to fight off infections that the researchers had detected before the gene therapy. Four of the eight discontinued immune-system boosting medications that theyd previously needed. Of those four, three developed antibodies in response to vaccination, indicating a fully functional immune system.

A year and a half after gene therapy, all children were healthy and growing normally.

The broad scope of immune function that our gene therapy approach has restored to infants with X-SCID as well as to older children and young adults in our continuing study at NIH is unprecedented, Malech says.

The researchers will continue to follow the participants over time. They plan to track how the childrens immune systems develop and look for any late side effects.

References:Lentiviral Gene Therapy Combined with Low-Dose Busulfan in Infants with SCID-X1. Mamcarz E, Zhou S, Lockey T, Abdelsamed H, Cross SJ, Kang G, Ma Z, Condori J, Dowdy J, Triplett B, Li C, Maron G, Aldave Becerra JC, Church JA, Dokmeci E, Love JT, da Matta Ain AC, van der Watt H, Tang X, Janssen W, Ryu BY, De Ravin SS, Weiss MJ, Youngblood B, Long-Boyle JR, Gottschalk S, Meagher MM, Malech HL, Puck JM, Cowan MJ, Sorrentino BP. N Engl J Med. 2019 Apr 18;380(16):1525-1534. doi: 10.1056/NEJMoa1815408. PMID: 30995372.

Funding:NIHs National Institute of Allergy and Infectious Diseases (NIAID); National Heart, Lung, and Blood Institute (NHLBI); and National Cancer Institute (NCI); American Lebanese Syrian Associated Charities; California Institute of Regenerative Medicine; and Assisi Foundation of Memphis.

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Gene Therapy Research: Then and Now

The idea of gene therapy is not new. In fact, scientist have been investigating and evolving it for more than 50 years, and, to date, more than 2300 gene therapy clinical trials are planned, ongoing, or have been completed.

Gene therapy research, some in very early stages, is focusing on many diseases that are partly or fully caused by genetic mutations, such as blood clotting disorders, for example hemophilia, cardiovascular disease, neurodegenerative disorders, such as Parkinsons disease, vision disorders, and musculoskeletal disorders.

The potential of gene therapy research brings hope to millions of people living with currently untreatable diseases.

Understanding Genetic Disease

Before you can understand what gene therapy research is, its important to know what a gene is. The human body is composed of trillions of cells. Within a cell, theres a nucleus, which contains chromosomes. Chromosomes are made up of DNA, which is the bodys hereditary material. Genes are segments of DNA. Genes contain instructions for making proteins, which are molecules that build, regulate, and maintain the body.

Sometimes theres a change in a genes DNA sequence. This is called a mutation and can cause a necessary protein to not work properly or to be missing. A mutation can be a substitution, deletion, or duplication. Some mutations are harmless, but others can result in a genetic disease.

Simply put, gene therapy is an investigational approach with the goal of treating or possibly preventing a genetic disease.

Exploring the Potential of Gene Therapy

One goal of gene therapy research is to determine whether a new or functional gene can be used to restore the function of or inactivate a mutated gene. One way for this to happen is to deliver a gene into a cell. To do so, a transporter, known as a vector, is typically used. A vector can be made from an altered virus. Which means that before the virus is used, its viral genes are removed. Vectors can be given intravenously, which means they are administered into a vein, or injected into a specific tissue in the body.

There are three commonly used vectors. One of them, adeno-associated virus, or AAV is not known to cause disease, which is why it may be used as a viral vector to transport a gene into the cell.

In this example, the gene delivered into the cell does not integrate into its DNA and cannot be passed down to new cells.

Once the cell has received the functional gene, it should address the mutation by producing the necessary protein or stopping production of the harmful protein. At Spark Therapeutics, we are using AAV vectors to advance research programs against strategically selected target tissues for example, the retina, liver, and central nervous system. Which is all part of our mission to challenge the inevitability of genetic disease.

Read more here:
About Gene Therapy: A Potential Treatment for Genetic Diseases

Be in the know about leading stem cell centers you can trust in this article.

In this article:

Stem cell clinics have received a great deal of negativepress,with prominent media outlets announcing that the Food and Drug Administration (FDA) had mailed Warning Letters to stem cell centers across the United States.According to a paper published in the journalCell Stem Cell in June 2016,at least 351 businesses offer unproven stem cell interventions fromclinics spread across the U.S.

Shortly after publication, the MIT Technology Reviewand Washington Postpicked up the story, spreading the fear far and wide.Journalists then got enthralled with the story, calling it the Wild West of stem cells.

But, is this the whole story?

What this hype does not cover isthe promising medical potentialof stem celltherapies, nor had it properly credited the legitimate stem cell clinics that comply with FDA regulations to offer effective medical treatments to populations of patients who otherwise have limited options.

Today, the majority of medical clinics that offer stem cell treatments administer mesenchymal stem cells (MSCs), which they source from human fat (adipose tissue) orbone marrow.

Mesenchymal stem cells are a type of multipotent stem cell that is administered for a range of medical applications, including orthopedic repair, pain management, arthritis, and asthma.

When properly administered, multipotent self-derived stem cells (such as MSCs) can be safe for patient use.

It is important that the cells be multipotent (limited in their differentiation capacity), rather than totipotent (can become any cell) or pluripotent (can become most cells). There is also an additional level of safety that comes from having stem cells be self-derived, which doctors and scientists call autologous.

Stem cell differentiation capacity is explained below:

While it is true that many stem cell centers are not properly regulated, the therapeutic promise of stem cells is also clear.

Today, nearly 30,000 scientific publicationshighlight research and therapeutic advanceswith mesenchymal stem cells (MSCs), and approximately850+ clinical trials are investigating therapeutic uses of MSCs. Additionally, 300,000+ scientific publications about stem cells have been released.

This momentum is not surprising, because We are not made of drugs, we are made of cells.

However, the biggest issue with the hype surrounding stem cell centers is that it does not give proper credit to the companies that cooperate with regulatory bodiesto ensure a safe and efficacious patient experience. Many of these companies also collaborate withoffshore regulatory bodies to offer stem cell procedures approved by local regulatory agencies.

The FDAsCenter for Biologics Evaluation and Research (CBER)regulates human cell and tissue-based products in the U.S., known as HCT/Ps. The FDA has two different paths for cell therapies based on relative risk.

These pathways are commonly called 361 and 351 products.

The 361 products that meet all the criteria in 21 CFR 1271.10(a)are regulated as HCT/Ps and are not required to be licensed or approved by the FDA. These products are called 361 products because they are regulated under Section 361 of the Public Health Service (PHS) Act.

In contrast, if a cell therapy product doesnot meet all the criteria outlined in 21 CFR 1271.10(a), then it is regulated as a drug, device, or a biological product under the Federal Food, Drug, and Cosmetic Act (FDCA) and Section 351 of the PHS Act.[1]

These 351 products requireclinical trials to demonstrate safety and efficacy in a process that is nearly identical to that what is required for pharmaceutical products to enter the marketplace.

Stem cell centers must ensure that their treatments meet the FDAs criteria to be classified as 351 products.

Below, we cover five leading stem cell centers. Each one has treated large populations of patients with adult stem cells. At least one (Regenexx) is maintaining a Patient Registry to document long-term patient outcomes.

We are not advising patients to seek treatments from these companies.We are identifying them to allow readers to seek out more information.

Founded by Dr. Neil Riordan, a globally recognized stem cell expert and visionary, the Stem Cell Institute in Panama is among the worlds leaders in stem cell research and therapy. Their treatments focus on well-targeted combinations of allogeneic umbilical cord stem cells, as well as autologous bone marrow stem cells.

The stem cells clinic uses stem cell therapies to treat various ailments, including the following:

One of their most recent studies exhibited the clinical feasibility of stem cell transplant process as a safe and effective treatment approach for patients with multiple sclerosis (MS).

Published in the Journal of Translational Medicine, the study showed that umbilical cord stem cells can slow down MS disease progression and decrease the frequency of flare-ups.

However, these stem cells did not exhibit the ability to repair damaged nerve cells or myelin sheaths.

After the completion of this clinical study, there was an improvement in MS patient disability. The 1-month mark of the study documented improvements in mobility, hand, bladder, bowel, and sexual functions. Importantly, the study demonstrated that a sustained one-year umbilical cord stem cell therapy has more durable benefits than current MS drug therapies.

Headquartered in Denver, CO, Regenexx offers self-derived (autologous transplant) same-day stem cell treatments to patients with orthopedic injuries and conditions. Regenexx clinicsincorporate a variety of regenerative approaches, drawing patients from all over the U.S. who are seeking innovative, non-surgical treatments.

TheRegenexx technologyinvolvesa procedure in whicha small bone marrow sample is extracted through a needle and blood is drawn from a vein in the arm. These samples are then processed in a laboratory and the cells they contain are injected into the area needing repair, with the goal of delivering large numbers of stem cells to the site of injury.

Regenexx is also a licensedoffshore clinic in the Cayman Islands where patients can undergo treatments that utilize laboratory-expanded (ex vivo) stem cell populations. This approach allows for a much larger number of stem cells to be administered to the patient than is supported by U.S. law, which currently prohibits laboratory procedures that the FDA considers to exceed minimal manipulation.

Dr. Christopher Centenois the Founder and CEO of Regenexx. He is a global authority in the culture expansion and clinical use of adult stem cells to treat orthopedic injuries and thevisionary behind the Regenexx technology.

I am also a Regenexx patient.Click here to read my experience.

Founded in 2011,Okyanosis a stem cell therapy provider that specializes in treating patients with congestive heart failure (CHF) and other chronic degenerative conditions. Okyanos Cell Therapy uses internationally-approved technology to deliver a mixed population of fat (adipose) derived stem and regenerative cells (ADRCs) to patients with conditions such as the following:

Okyanos maintains both a North American Office in Clearwater, FL, and a purpose-built Cell Therapy Surgical Center inFreeport, GrandBahama. Okyanos stem cell treatments are performed in their state-of-the-art surgical centers under the care of board-certified doctors.

Okyanos is also fully licensed and regulated under the Bahamas Stem Cell Therapy and Research Actand adheres to U.S. surgical center standards. Click here to access our recent interview withMatthew Feshbach, Co-Founder and CEO of Okyanos.

The Global Institute of Stem Cell Therapy and Research (GIOSTAR) provides adult stem cells for autologous and allogeneic stem cell therapy to patients around the world, based on research byDr. Anand Srivastava. The stem cell clinic offers adult stem cells for rejuvenation treatment, muscular injuries, and degenerative diseases.

Each of GIOSTARs clinics is licensed for the application of stem cell therapy.Since 2000, its team of scientists and clinicians have been developing and utilizing stem cell-based clinical protocols for the purpose of stem cell treatment.

Although the company is headquartered in San Diego, California, GIOSTAR Mexico has provided stem cell therapy to patients from all over the world. Mexicos regulation of stem cell therapeutics differs from the regulations imposed by the U.S. FDA, making it a growing site for medical tourism.

Celltex specializes in cryopreserving mesenchymal stem cells (MSCs) for therapeutic use. Celltex acquires stem cells by collecting a small fat sample from a patient, from which MSCs are extracted,isolated, multiplied, and stored for future use (known as cell banking).

Patients can then use their stored stem cells for regenerative purposesthrough infusions or injections performed by a licensed physician.

Because the FDA considers an individuals stem cells a drug if they have been expanded in large quantities, Celltex has begun the process of undertaking clinical trials on stem cells as a treatment for a range of medical conditions, seeking approval from the FDA to allow physicians to utilize these cells.

Nonetheless, to meet the immediate needs of its clients, the company also has taken steps to meet the requirements of the FDA and COFEPRIS, a Mexican institution equivalent to FDA in MSCs import and export.

Celltex also works with Mexican hospitals that are established and certified that allowed the companys cell-banking clients to receive their stem cells for medical purposes.

Although these leading stem cell centers have built a good reputation in regenerative medicine, it is still important to probe these clinics before the proper procedure. These questions should cover what to expect from the treatment, safety and emergencies, cost, and the patients rights.

Treatment

Safety and Emergencies

Costs

Patients Rights

Understanding how these leading stem cell centers operate and what they do allows the patient to assess which of them is the right investment. While the information above is important to understand from a scientific and regulatory perspective, patient experiences are valuable too.

If you found this blog valuable, subscribe to BioInformants stem cell industry updates.

As the first and only market research firm to specialize in the stem cell industry, BioInformant research is cited by The Wall Street Journal, Xconomy, AABB, and Vogue Magazine. Bringing you breaking news on an ongoing basis, we encourage you to join more than half a million loyal readers, including physicians, scientists, executives, and investors.

Have you had a stem cell transplant?What stem cell clinic did you use? What treatment did you get and for what condition? Share your answers in the comments below.

Footnotes [1] Aabb.org. (2017). Cellular Therapies. [online] Available at: http://www.aabb.org/advocacy/regulatorygovernment/ct/Pages/default.aspx [Accessed 1 Aug. 2017].

What Stem Cell Clinics Do You Trust?

Here is the original post:
What Stem Cell Clinics Do You Trust? | BioInformant

PROCEDURE

What is anAutologousAdipose Stem Cell Procedure?

A small sample of Adipose tissue (fat) is removed from above the Superior Iliac spine (love handles) or abdomen under a local anesthetic.

How do I know if stem cell therapy is right for me?

Discussing treatment options with your physician is an important first step in making a decision regarding stem cell therapy. Potential outcomes, an integrative and comprehensive treatment plan, and financial costs are all factors to consider.

A small sample of Adipose tissue (fat) is removed from above the Superior Iliac spine (love handles) or abdomen under a local anesthetic.

Obtaining Adipose-Derived Stem Cells (ADSCs) is much easier and less invasive than performing a bone marrow extraction. In addition, adipose tissue contains much larger volumes of mesenchymal stem cells than does bone marrow. We use the patient's own adipose tissue to extract the stem cells. Autologous means that the donor and the recipient are the same person.

Benefits of ADSCs: Stem cells play an integral part in wound healing and regeneration of tissue at the cellular level.

What is anAutologousAdipose Stem Cell Procedure?

Is this procedure a significant improvement on other treatments currently available?

The Major Advantages of Adipose Stem Cell Therapy:

Our technology allows us to complete the entire procedure on the same day, using less than minimally manipulated methods.

*High Yield: A high-dose of stem cells can be obtained in just a couple of hours.

*Mesenchymal stem cell yields from peripheral fat are much higher than from bone marrow.

*Patients receive their own autologous cells, so there is a very low risk of immune rejection.

*A minimally invasive outpatient procedure makes it easier to harvest from fat than from bone marrow and more comfortable for patients.

Yes We can now obtain Adult Stem Cells (ASCs) from a fat sample. This in-clinic treatment is completed the same day, and there is no need to ship samples to an outside laboratory and wait days for the cells to be returned for an injection on a second visit.

This faster process provides increased stem cell counts, without manipulation.

Is an Autologous Adipose Stem Cell Procedure Safe?

Yes because the adipose tissue is removed from one's own body via sterile technique and remains in a controlled environment there are no problems with cell rejection or disease transmission.

The interview, physical, harvesting, and administration of stem cells are all performed in-house under a physicians control.

How do I know if stem cell therapy is right for me?

Discussing treatment options with your physician is an important first step in making a decision regarding stem cell therapy. Potential outcomes, an integrative and comprehensive treatment plan, and financial costs are all factors to consider.

I have heard Stem Cell Treatments are VERY expensive, can I afford this?

Yes you can!

Due to our advanced adult stem cell technology provided in the form of an in house procedure, our Stem Cell Center can now provide this service at a fraction of the cost previously incurred. Even better, its a same day procedure.

We offer theentirety of our treatment in Phoenix, Arizona -USA and we have been able to lower our cost to a flat rate of $7,100.00 per treatment (including consultation). Fees are subject to change and some more complex proceduresmay incur additional costs.

Why Choose an Adipose Stem Cell Procedure?

Adipose-derivedmesenchymalstem cells areeasier to harvest than bone marrowand can be obtained in much larger quantities. In addition, it is much less painful and involves lower risks.

*There is a much shorter time from extraction to the administration oftreatment.No culturing or manipulation is needed using our procedure, as opposed to a bone marrow extraction which requires days or weeksto reach the necessary therapeutic threshold.

*There are no ethical or moral issues involved in harvestingautologousAdult Stem Cells (ASCs).

Are There Detrimental Side Effects from an Adipose Stem Cell Procedure?

No, the adipose tissue is extracted from the patients own body sono foreign donors are used. This minimizes the potential for immune rejection.Our procedure is performed completely in-house and administered by licensed physicians here in the United States.

Please keep in mind that every procedure does have its risks, but we do practice sterile technique which makes the risk of infectionvery low.In fact, we have not had any infections develop in any of the stem cell patients we have treated as we take great care in keeping a sterile environment.

AutologousGrowth Factor Components ofPRP:

PRP(Platelet Rich Plasma) contains many growth factors, and has been successfully used clinically to improve hard and soft tissue healing

TGF-(Transforming growth factor alpha & beta)

EGF(Epidermal growth factor)

FGF(Fibroblast growth factor)

IGF(Insulin growth factor)

PDEGF(platelet derived epidermal growth factor)

PDAF(platelet derivedangiogenesisfactor)

IL-8 (Interleukin-8)

TNF-(Tumor necrosis factor alpha)

CTGR(Connective tissue growth factor)GM-CSF (Granulocytemacrophage colony stimulating factor)

KGF(Keratinocytegrowth factor)

High concentration of leukocytes (neutrophils,eosinophils) formicrobicidalevents

High concentration of wound macrophages and otherphagocyticcells, for biological debridement

Histamines, Serotonin, ADP,ThromboxaneA2, and othervasoactiveandchemotacticagents

High platelet concentration and native fibrinogen concentration for improvedhemostasis

What You Can Expect When Visitingthe Stem Cell Rejuvenation Center:

Consultation: Each patient receives a consultation lasting up to 1 1/2 hours prior to the treatment: History, Medications, Patient desires and expected outcomes are discussed.

Harvest:Using a tumescent anesthetic, a sample of adipose tissue is collected from the patient.

PRP:If needed, it is isolated from the patient's own blood.

Stem Cells:Ourlaboratory staff will isolate the Adult Stem Cells (ASCs) and other progenitor cells in a sterile environment from the collected fat sample ensuring that no contamination occurs. There is a difference betweenaspeticand sterile technique. It is extremely important to note that sterility means that the cells are not exposed to air particles and contaminants.

Prepare: If the doctor wishes, she/he will offer antioxidant and nutritional IV's prior to infusion to prepare the patient for the therapy.

Infuse:The cells are then administered back to the patient through one or more of the following modes of administration:

Intravenous:The Stem Cells are administered via an intravenous push

Localized:The Stem Cells are administered directly into a localized area.

Intramuscular:The Stem Cells are implanted into the muscle.

Intranasal:This therapy relies on direct transmission through thecribiformplate, bypassing the Blood Brain Barrier, along the olfactory andtrigeminalnerve pathways.

Differences BetweenAn Adipose And A Bone Marrow Procedure:

Disclaimer:Even though our Treatments are done usingautologouscells, our Stem Cell Therapies are not approved by the FDA. Stem Cell Treatments are not a cure for any condition, disease or injury, nor a substitute for proper medical diagnosis and care.Again, StemCell Treatments are not a cure for any condition, disease or injury, nor a substitute for proper medical diagnosis and care. The information we communicate is not medical advice. It is intended to be used for educational and information purposes only. We do not usecollagenasein our stem cell treatment.Its important for you to do your own research based on the options that we present to you so that you can make an informed decision.

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Stem Cell Procedure | Arizona | Stem Cell Rejuvenation Center

POSTED ON 03/26/2017 IN Knee Latest News BY Chris Centeno

Given the quite reasonable concerns this past week over the blinding of three womenby a stem cell clinic injecting fat stem cells into eyes, I thought it was time to take a look at stem-cell-procedure complications. All medical procedures have complications. So what bar can we use to see if those complications are reasonable, and how should those be reported and measured?

First, to decide what complications might be reasonable, we need to understand the playing field of common side effects of conventional treatments. So what are some common complications in my world of orthopedic care, and how often do they happen?

So conventional procedures and widely used medications can have big time complications and rates!

To date, I think weve reported the most comprehensive paper on stem-cell-related complications. In more than 2,300 patients and 3,000 procedures, the total complication rate was 2.0%. Of those, four were deemed to be more serious and definitely related to the procedure by at least one independent reviewer not related to our group. Since this is out of 3.012, this is a serious-complication rate of 0.13%. Pretty small compared to the rates reported above for common orthopedic procedures.

This week we saw reported that the complication rate for the fat stem cell clinic that blinded three consecutive patients was approximately 0.01%. That seems about ten times less, despite the significant reported complications. Why? The data is an apples to oranges comparison.

For our reported data, a registry infrastructure was used where questionnaires were sent to every patient, and if they failed to respond, telephone calls were made. Based on conversations I have had with participating physicians, the stem cell outfit with the complications uses a passive system where the doctors are told to report the complications. Its likely that pinging patients about whats wrong can find more complications when compared to relying on a busy physician to report his or her complications.

Regrettably, the stem cell outfit that blinded these patients hasnt published any safety data on the widespread use of fat stem cells, so there is no research to review. This is concerning.

As you can see from the above risks, stem-cell-based orthopedic therapies have low-risk profiles when compared to conventional orthopedic procedures. Hence, when complications do occur, they are rare. However, to determine risk, efficacy is also needed as part of the calculus. So lets look at knee replacement.

So how good is knee replacement compared to garden-variety physical therapy (PT)? Not great. In a recent study (video below), 3 in 4 knee-replacement candidates undergoing PT instead of surgery decided not get a knee replacement after one year.Also you need to amputate 56 knees to find just one patient who reports more than a 15% functional improvement as a result of this maximally invasive surgery.

Looking at the relative efficacy of two procedures is hard without a head-to-head comparison trial. However, in the case of knee arthritis, we can comparetwo different studies that both compare to PT. In the above caseof knee replacement, we know how that invasive procedure fared, and below well look at a same-day stem cell procedure.

For the stem cell procedure, well be looking at the Regenexx bone-marrow-based version. Below is a graphic that discusses that out of more than 5,000 knee stem-cell-treated patients, as of this month, only about 12% went on to get a knee replacement despite their treatment at 12 years. This was based on 100% response rate from a random sample of 100 registry patients.

Below are the yet unpublished results of our randomized controlled trial where knee-replacement candidates were treated with our Regenexx knee stem cell procedure versus physical therapy:

The patients with a stem cell procedure report more knee function more quickly compared to the physical therapy group (listed here as Exercise Therapy). The PT group crossed over to the stem cell procedure at three months, which is why the PT data is only tracked for that long.

So comparing risks and benefits of these two therapies, the risk of knee replacement is significantly greater and the outcome based on a randomized controlled trial is likely no better than a stem cell injection. Hence, the risk/benefit of a Regenexx-protocol knee stem cell procedure is good compared to traditional care.

The upshot? While the risks of stem cell therapy are likely lower than most traditional treatments, for some indications, like injecting fat stem cells in the eye, that equation goes in the wrong direction. The goal with todays review was also to open a debate about when stem cell therapy is likely the better option.So lets have a reasonable discussion about stem cell risks and not throw the baby out with the bathwater!

*DISCLAIMER: Like all medical procedures, Regenexx Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.

Originally posted here:
Outcomes, Complication Rates, and Stem Cell Procedures ...