StemCell Therapy

13 February 2012 Last updated at 19:52 ET By James Gallagher Health and science reporter, BBC News

Damage caused by a heart attack has been healed using stem cells gathered from the patient's own heart, according to doctors in the US.

The amount of scar tissue was halved in the small safety trial reported in the Lancet medical journal.

The authors said there was also an "unprecedented" increase in new heart muscle.

The British Heart Foundation said it was "early days", but could "be great news for heart attack patients".

A heart attack happens when the organ is starved of oxygen, such as a clot blocking the flow of blood to the heart.

As the heart heals, the dead muscle is replaced with scar tissue, but because this does not beat like heart muscle the ability to pump blood around the body is reduced.

Doctors around the world are looking at ways of "regenerating" the heart to replace the scar tissue with beating muscle. Stem cells, which can transform into any other type of specialised cell, figure prominently in their plans.

Heart to heart

This trial, at the Cedars-Sinai Heart Institute, was designed to test the safety of using stem cells taken from a heart attack patient's own heart.

Continue reading the main story Healing the heart

This is the second group of doctors to report using cells taken from a heart to heal a heart.

In November 2011, another safety trial showed the cells could be used to heal the hearts of heart failure patients who were having heart bypass surgery.

The heart is not the only source for these stem cells and other fields are much further ahead.

The largest ever trial of stem cell therapy in heart attack patients is about to get under way in Europe.

The BAMI trial will inject 3,000 heart attack patients with stem cells taken from their bone marrow within five days of the heart attack.

Within a month of a heart attack, a tube was inserted into a vein in the patient's neck and was pushed down towards the heart. A sample of heart tissue, about "half the size of a raisin", was taken.

This was taken to the laboratory where the stem cells were isolated and grown. Up to 25 million of these stem cells were then put into the arteries surrounding the heart.

Twenty five patients took part in the trial. Before the treatment, scar tissue accounted for an average of 24% of their left ventricle, a major chamber of the heart. It went down to 16% after six months and 12% after a year.

Healthy heart muscle appeared to take its place. The study said the cells, "have an unprecedented ability to reduce scar and simultaneously stimulate the regrowth of healthy [heart] tissue".

One of the researchers Dr Eduardo Marban said: "While the primary goal of our study was to verify safety, we also looked for evidence that the treatment might dissolve scar and regrow lost heart muscle.

"This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it.

Continue reading the main story “Start Quote

These cells have been proven to form heart muscle in a Petri dish but now they seem to be doing the same thing when injected back into the heart as part of an apparently safe procedure”

End Quote Prof Jeremy Pearson British Heart Foundation

"The effects are substantial, and surprisingly larger in humans than they were in animal tests."

However, there was no increase in a significant measure of the heart's ability to pump - the left ventricle ejection fraction: the percentage of blood pumped out of the left ventricle.

Prof Anthony Mathur, who is co-ordinating a stem cell trial involving 3,000 heart attack patients, said that even if the study found an increase in ejection fraction then it would be the source of much debate.

He argued that as it was a proof-of-concept study, with a small group of patients, "proving it is safe and feasible is all you can ask".

"The findings would be very interesting, but obviously they need further clarification and evidence," he added.

Prof Jeremy Pearson, associate medical director at the British Heart Foundation, said: "It's the first time these scientists' potentially exciting work has been carried out in humans, and the results are very encouraging.

"These cells have been proven to form heart muscle in a petri dish but now they seem to be doing the same thing when injected back into the heart as part of an apparently safe procedure.

"It's early days, and this research will certainly need following up, but it could be great news for heart attack patients who face the debilitating symptoms of heart failure."

See the original post:
Cells 'heal' heart attack scars

13-02-2012 12:31 Sridhar Ramaswamy, MD, Tucker Gosnell Investigator and Associate Professor of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Broad Institute of Harvard and MIT, and Harvard Stem Cell Institute, discusses ongoing research into drug tolerance and resistance, specifically the roll of dormant cancer cells. If a tumor goes into remission as a result of a cancer drug and then recurs it is likely that the tumor will still respond to the initial treatment. In the dormant state the cells are resistance, in the original they are sensitive. The exact mechanism behind this has yet to be discovered. In some cases giving a course, stopping, and then continuing later on can create an additive effect, an idea that Ramaswamy calls a drug holiday. A comparison is underway between drug and non-drug induced dormant cells in order to find the mechanism that causes resistance. The ultimate goal of the research is to be able to predict and stop drug resistance.

See the article here:
Dr. Ramaswamy on Dormant Tumor Cells and Resistance - Video

Posted: Monday, February 13, 2012 7:30 am | Updated: 1:35 pm, Mon Feb 13, 2012.

The time is ticking toward the 100th anniversary of when Balboa Park became a jewel. We need to move quickly if we want to make the park look more like it did when it first sparkled in front of a worldwide audience in 1915.

There seems to be a general consensus that the park could use some work. But an embittered battle has erupted over exactly what needs to be nipped, tucked and relocated.

Our Scott Lewis ponders the debate over the park's future in the latest of his look at stories to watch in 2012.

He notes that the group planning for a big 2015 celebration has hired a new CEO and says the City Council could decide as soon as June whether to remove cars from the Plaza de Panama (the section of the park between the art museum and the organ pavilion). Preservationist leaders have lined up against the plan.

Lewis says it helps to think of it as the same type of argument that may precede major elective surgery. Find out how.

• This is part of a series of 12 stories Lewis thinks should pay attention to for the next year. Here was No. 12: the Chargers; No. 11: the Convention Center; No. 10: The city of San Diego's financial problems; No. 9: the San Diego Police Department; and No. 8: affordable housing.

In Escondido, a Donor Keeps Streets Smooth

For years, we've been following what we call "the dissolving city" as San Diego has increasingly left it to residents to take care of things like building maintenance and school expenses. Scott Lewis explained the concept here for the city and here for the schools.

When the mayor admitted the city would never have the funds to take care of Balboa Park while introducing the conservancy, that was part of the trend.

But parks have always attracted donor support. In Escondido, a local contractor has taken things to an extreme: He's donated as much as $100,000 a year to help the city fill hundreds of potholes.

The contractor's crew boosted the city's pothole-filling services by about a third, the NC Times reports.

• Related, in New York City, the City Council will begin identifying city needs and helping businesses and civic groups use the crowdfunding service Kickstarter to fund them. On Kickstarter, you pitch an idea for a effort that needs donations and people can pledge support. If you meet your goal, then the project is kickstarted.

Last Day to Decry Football Blackouts

Many San Diegans are horrified when home Chargers games get blacked out because too few people buy tickets. Some fans feel obliged to go outside, where there's a disturbing shortage of couches, beer commercials and TV screens. Shudder.

Well, you can try do something about the blackouts, but you better hurry. The Federal Communications Commission is reviewing the rules and accepting public comment, but only until today. "Aggrieved fans in Cincinnati, Tampa, Oakland, San Diego, Buffalo, Jacksonville — you have the floor," says deadspin.com. A website says it will accept your comments and ideas online and deliver them to the FCC.  

Beep No More

If you're like me -- and please see a doctor if that lasts more than four hours -- you're always setting off security gate alarms even though you're not a shoplifter. Those flapping security gate things at libraries are a special problem for me, perhaps due to my electric personality.

Well, now I'm in luck and you may be too: the city's libraries have quietly stopped turning on their security gate systems, and the county library system has dumped the gates entirely, the U-T reports.

Numbers from the city library system suggest that thefts may be on the rise, big-time, but the meaning of the statistics is fuzzy. 

"Long story short: People steal from libraries. U-T wants to blame the libraries, but can't figure out how," wrote the mayor's special projects man Gerry Braun, a former U-T columnist, on Twitter.

In Focus at UCSD: Occupiers, Dead Bees, Stem Cells

The folks at UCSD's media relations department may deserve a raise. The university's faculty has gotten plenty of press lately:

• A stem cell scientist explains in a Sacramento Bee commentary why the public has to support the kind of research he does because venture capitalists aren't cough up money as much as before.

• USA Today says a professor's new course on social movements is focusing on the Occupy Wall Street protesters

• A biology professor tells alternet.org that "pesticides, disease, parasites, and human mismanagement" are responsible for the big bee die-off.

Check our earlier stories for details about UCSD's research into why so many bees have gone to that big hive in the sky.

A Kiss Before Leaving

"Unconditional Surrender," the hulking statue honoring the famous kissing sailor-nurse couple from V-J day, drives some naysayers around the bend. Former U-T art critic Robert Pincus was forced to turn to the words of noted philosopher Woody Allen to find the perfect way to describe his disgust: "It's a travesty of a mockery of a sham of a travesty of two mockeries of a sham.”  

But tourists love it. Just check out all the photos of it online. (Not all are from here, though, since the statue has many twins).

Now, the 6,000-pound statue -- a "foam-urethane object," as the U-T not-so-smoothly describes it -- is scheduled to move on and torture art critics somewhere else. But there's a catch, and no, it's not the unwillingness of anyone else to take the thing.

A local architect wants to raise almost $1 million to keep the statue here in town permanently, the U-T reports. The port's public art committee rejected the proposal in December, although it was divided.

If the "foam-urethane object" does stick around, here's hoping the port makes triple-sure that it's earthquake-safe. Otherwise, some unsuspecting bystander -- like, say, me -- may give a new meaning to the statue's name the next time the ground shakes.

Please contact Randy Dotinga directly at randydotinga@gmail.com and follow him on Twitter: twitter.com/rdotinga.

Excerpt from:
Morning Report: Balboa Park's Future

It started when Deborah Bishop was still in her 20s.

Always athletic -- she had participated in field hockey, speed skating and baseball -- Ms. Bishop was doing jumping jacks when she noticed to her embarrassment that she had leaked urine.

As the weeks wore on, the Canadian woman began to have more and more of these accidents. It wasn't just strenuous exercise that caused them, but also being tickled or coughing or sneezing.

The condition is known as stress urinary incontinence, and researchers say it may affect hundreds of millions of people around the world, primarily women, who are more susceptible because of their anatomy.

Today, Ms. Bishop, 54, is "90 percent" normal on her urinary leakage, she said -- all because of an injection of her own stem cells that she received three years ago.

The cells, known officially as autologous muscle-derived cells, were taken out of her thigh, multiplied several times over in the lab, and then injected into the muscles around her urethra, the opening at the neck of the bladder.

While many people still associate the phrase "stem cells" with ethical debates over using embryos, these stem cells have nothing to do with that.

All of us have stem cells in various parts of our bodies that can develop into mature cells and are used to repair muscle, nerve and tissue damage.

In this case, researcher Johnny Huard at the University of Pittsburgh developed a technique for finding stem cells in muscle tissue and then purifying and multiplying them. The biomedical firm Cook MyoSite Inc. bought the licensing rights to his technique and is overseeing the current tests on treating stress urinary incontinence.

The idea is that the stem cells will create new cells that will strengthen the muscles that control urination. Even though the initial trials were focused on testing the safety of the procedure, 60 to 70 percent of the women have shown a significant decrease in their urinary leakage, said Ryan Pruchnic, Cook MyoSite's director of operations.

Lesley Carr, Ms. Bishop's physician and a urologist at Sunnybrook Health Sciences Centre in Toronto, said there is no medication that helps with this most prevalent form of incontinence. Up to now, the primary last-resort therapy has been surgical insertion of a mesh sling around the urethra.

The surgery is effective, Dr. Carr said, but "there are rare but recognized complications," including pain and infections, and women face up to six weeks of restricted activity after the operation.

That was a big obstacle for Ms. Bishop, not only because she is so physically active, but because she was in the middle of a house renovation when she sought help for her condition.

"I told Dr. Carr I couldn't afford to be out of commission for six weeks," she recalled, "and that's when she must have mentioned the stem cell trial to me."

In July 2009, she had a piece of her outer thigh muscle removed under local anesthesia, a procedure she admits left her feeling "like I'd been kicked by a horse" for about a week.

Researchers then located and multiplied the stem cells in her muscle tissue, and the following September, she had them injected into the muscles around her urethra. The entire injection took about five minutes, she said, and she felt nothing.

The improvement was gradual after that. "I noticed a difference in a couple months," she said, "and a significant difference in four or five months. I thought what made it really unique was that it was using my own muscle cells."

The procedure means that today, she can do her strenuous morning exercises of standing broad jumps and stride jumps without having to wear heavy pads to absorb leakage.

The latest trials with the stem cells are the first to enroll women who will either get real stem cells or placebo injections. Cook MyoSite hopes to have solid results and be able to bring the procedure to market by 2015, Mr. Pruchnic said.

The company has also begun initial tests of the muscle stem cells in people who have had heart attacks or are experiencing chronic heart failure, in hopes they will restore the strength and flexibility of cardiac muscle.

By using a person's own cells, Dr. Carr noted, there is no need for patients to take immunosuppressive medications. She believes such regenerative medicine "will be the wave of the future in most fields" of health care.

Ms. Bishop is certainly sold.

"I've got a girlfriend who's had three children and is very physically active, and she's struggling with stress incontinence now, and so I'm an advocate for this.

"It was an excellent experience for me, and I would highly recommend it to anyone."

Mark Roth: mroth@post-gazette.com or 412-263-1130.

First published on February 13, 2012 at 12:00 am

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Stem cell injection successfully treats urinary incontinence

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...

COLUMBIA, SC (WIS) - Cutting-edge arthritis treatment for our four-legged family members is now available in Columbia.

Banks Animal Hospital is the first in the area to offer in-house Stem Cell therapy. It uses your pets own body to heal itself.

Take 13-year-old Maggie, for example. The energetic pup has a limp that usually keeps her from jumping or going up stairs.

"Today when everybody's out there filming her little limp it's not as pronounced because she wants to please," said Maggie's owner, Beth Phibbs. "She's just a great dog."

But a great attitude wasn't enough to repair a bad case of cervical spine arthritis.

So Monday, Beth brought Maggie to Banks Animal Hospital for the Stem Cell therapy. Like many, Beth had never heard of Stem Cell work in animals. "Until Dr. Banks mentioned it to me I was like, beg your pardon?"

"There's no down side, no side effects because you're using your own cells," said Dr Ken Banks.

Banks and his staff first gather some of Maggie's blood and fat. Both are good places to find the repair cells they're after. Adult stem cells, not the controversial embryonic kind, are then separated and spun down.

"The repair system in Maggie's body has failed," said Jason Richardson of MediVet-America. "It's fallen asleep at the wheel, we're taking these repair cells, activating them so a chronic condition like osteo arthritis to Maggie will now be an acute illness."

This kind of treatment used to take days with material being shipped across the country, but now it can be done in hours.

"The ability to do it same day, convenience, the ability to do it in clinic saves a lot of money to the doctor which he can then pass on to the patient," said Richardson.

The treatment will still run you around $2,000, but Richardson says that's half of what the similar treatment use to cost.

When it's over, Maggie should be able to live out her life pain and drug free -- something Phibbs is looking forward to.

"I'm hoping in a couple of weeks she's gonna have a new lease on life," said Phibbs.

Copyright 2012 WIS. All rights reserved.

Continue reading here:
Vet offers stem cell therapy for dogs

February 14, 2012, 12:22 AM EST

By Ryan Flinn

Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

--Editors: Angela Zimm, Andrew Pollack

-0- Feb/13/2012 22:32 GMT

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows

WALKER, Mich. (WOOD) - Dogs who received the first in-clinic stem cell therapy in West Michigan returned to the vets who treated them Monday morning.

Boris and Natasha returned to Kelley's Animal Clinic for their 60-day checkup after receiving stem cell treatment in December 2011.

Dr. James Kelley and his staff of vets removed fat tissue from the dogs and activated it with an enzyme before injecting it into their back legs.

This adult animal stem cell technology is different from the controversial embryonic stem cell therapy.

Kelley said both dogs are doing amazingly well and that the procedure has done more than just help their arthritis.

"We're finding that not only the joints are affected, the rest of the animal is affected as well," said Kelley. "The skin is better. The attitude in these dogs is much improved."

Kelley and his staff have done 16 stem cell treatments since the first on Boris and Natasha, and he said all the dogs are showing signs of improvement after a short period of time.

Continue reading here:
Dogs who got stem cell therapy are well

MONDAY, Feb. 13 (HealthDay News) -- Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.

The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.

Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.

"In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it," said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.

However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.

The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.

The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.

Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells -- 12 million to 25 million -- that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.

One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.

Initial muscle damage and healed tissue were measured using MRI scans.

After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event -- a heart attack -- might have been related to the treatment, according to the study.

In a news release, Marban said that "the effects are substantial and surprisingly larger in humans than they were in animal tests."

Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.

"This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging," he said.

Another specialist said that while provocative and promising, the findings remain early, phase-one research. "It's a proof-of-concept study," said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.

And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.

"It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability," Lavie noted. "Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors."

Povsic concurred that much larger studies are needed. "The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better."

It's unclear what the cost will be, Povsic added. "What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money."

Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, "it might be useful in treating 'irreversible' injury that may persist after those procedures."

As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.

More information

The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.

See the original post here:
Stem Cell Treatment Might Reverse Heart Attack Damage

LOS ANGELES, Feb. 13, 2012 /PRNewswire/ -- The Society for Brain Mapping and Therapeutics (SBMT) announced today that the organization will hold its 9th Annual World Congress on Brain, Spinal Cord Mapping, and Image Guided Therapy from June 2-4, 2012 in Toronto, Canada.  The world's top brain and spinal cord scientists and surgeons will converge on the Toronto Metro Convention Center to find solutions to some of the most difficult to treat neurological disorders, including traumatic brain and spinal cord injuries, Parkinson's Disease, Alzheimer's Disease, and neurological cancers. 

The 2012 World Congress of SBMT is jointly supported by the American Association of Neurological Surgeons, the Government of Canada, the University of Toronto, and MaRS innovation; it is endorsed by the International Society for Magnetic Resonance Imaging in Medicine.

The theme of this year's World Congress is "Nano-Bio-Electronics," which focuses on the integration of nanotechnology, stem cell research, and biomedical engineering, and imaging of the brain and spinal cord to make progress in the fight against neurological diseases. The aim of the Congress is to provide a multidisciplinary forum for health professionals in the fields of neurosurgery, neurology, psychiatry, radiology, neuroscience, engineering, as well as policymakers, to collaborate as a global alliance to rapidly advance treatment of neurological disorders.

"The meeting will help us kick start a unique and efficient consortium, which will unite scientists and consolidate resources in order to help us quickly come up with solutions for the devastating neurological diseases affecting millions and costing billions in the US alone," said Babak Kateb, Chairman of the Board of SBMT, President of the Brain Mapping Foundation, and Director of the National Center for Nano-Bio-Electronics (NCNBE). Dr. Kateb states, "The purpose of the Nano-Bio-Electronic alliance is to facilitate integration of nanotechnology, Stem cell and cellular therapy with medical devices and imaging. This consortium will impact global biomedical science and healthcare delivery through national and international partnerships with governments, universities, leading organizations and industries."

Among the notable participants of the 2012 World Congress includes Canadian Surgeon General Hans W. Jung, U.S. Navy Surgeon General Matthew Nathan, and Canadian Parliament Member Kirsty Duncan.  Dr. Duncan, an advocate for brain research in Canada and a global voice for neuroscience initiatives, stated "I am honored to participate in this important conference.  It is vital that we work to enhance our understanding of brain health through research and collaboration."  She added, "We must also affirm our commitment to improving the quality of life of those who live with a brain condition and of their families and informal caregivers."

Toronto was chosen for this year's meeting because of the city's strong and globally-connected network of neuroscientists, biomedical engineers, and investors in the biomedical and nanotechnology fields.   Michael Fehlings, chairman of the local organizing committee, Professor of Neurosurgery, and Director of the Neuroscience Program at the University of Toronto, said "The meeting will showcase Canadian and international neuroscience talent in a broad range of disciplines and will highlight the latest advances in imaging, molecular and cellular mechanisms, bioengineering and surgical intervention."

Parimal Nathwani, Vice President of MaRS Innovation, added, "Forums like this represent an excellent opportunity for reviewing technologies and supporting collaboration across different institutions for more effective translation and commercialization opportunity."

The 9th Annual World Congress is still accepting abstract proposals for the meeting's workshops, lectures, and presentation sessions. Abstract submission  is open now until March 15th 2012.

For the full list of 2012 speakers to register, or support of the 9th Annual World Congress of SBMT on Brain, Spinal Cord Mapping, and Image-Guided Therapy, please visit http://www.worldbrainmapping.org  or call (310) 500-6196.

Society of Brain Mapping and Therapeutics
SBMT is a non-profit society organized for the purpose of encouraging basic and clinical scientists who are interested in areas of Brain Mapping and Intra-operative Surgical planning to improve the diagnosis, treatment and rehabilitation of patients afflicted with neurological disorders.

This society promotes the public welfare and improves patient care through the translation of new technologies into life saving diagnostic and therapeutic procedures. The society is committed to excellence in education, and scientific discovery. The society achieves its mission through multi-disciplinary collaborations with government agencies, patient advocacy groups, educational institutes and private sector (industry) as well as philanthropic organization. http://www.IBMISPS.org

University of Toronto Neuroscience Program
The University Of Toronto Faculty Of Medicine established the U of T Neuroscience Program (UTNP) as a new academic program and appointed Professor Michael G. Fehlings as its first Director on September 1, 2008. The UTNP is a robust, integrated and collaborative academic program in neurosciences that leverages the unparalleled health science network at the University of Toronto, which includes U of T's many departments and institutes, health science faculties, 9 fully-affiliated research hospitals and 20 community-affiliated hospitals and clinical care sites.

MaRS Innovation
MaRS Innovation provides an integrated commercialization platform that harnesses the economic potential of the exception discovery pipeline of 16 leading academic institutions in Ontario. MaRS Innovation is a not-for-profit organization with an independent industry- led board of directors, funded through the Government of Canada's Networks of Centres of Excellence, the Province of Ontario through the Ministry of Research and Innovation, and contributions of its member institutions. Designed to enhance the commercial output of Toronto's outstanding scientific research cluster, MaRS Innovation will make a significant contribution to Canada's economic outlook and the quality of life for Canadians and others around the world. MaRS Innovation will advance commercialization through industry partnerships, licensing and company creation. The MaRS Innovation mission is to put Canada on the global innovation stage, by better connection of research with industry and strengthening Canada's competitive capacity in the knowledge based business – in short, to launch a new generation of robust high growth Canadian companies.  www.marsinnovation.com

American Association of Neurological Surgeons
The American Association of Neurological Surgeons (AANS) is the organization that speaks for all of neurosurgery. The AANS is dedicated to advancing the specialty of neurological surgery in order to promote the highest quality of patient care.  http://aans.org

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U.S. and Canadian Scientists Form a Global Alliance for Nano-Bio-Electronics in Order to Rapidly Find Solutions for ...

(RTTNews.com) - Biotechnology company Seattle Genetics Inc. (SGEN) Monday reported a loss for the fourth quarter that narrowed from a year ago, due mainly to sales of Hodgkin Lymphoma drug Adcetris approved last August. Loss for the quarter was smaller when compared to analyst estimates, while revenues too came in ahead of expectations.

Looking ahead, Seattle Genetics detailed its revenue forecast for 2012. Nonetheless, investors were not too impressed with the results, sending Seattle Genetics shares down 7 percent in after hours trade on the Nasdaq.

The Bothell, Washington-based company reported fourth-quarter net loss of $27 million or $0.24 per share compared to net loss of $34.5 million or $0.34 per share last year.

On average, 14 analysts polled by Thomson Reuters expected a loss of $0.31 per share for the quarter. Analysts' estimates typically exclude special items.

Results for the 2011 quarter include an $8.7 million valuation adjustment related to holdings in auction rate securities.

The company reported revenues of $48.9 million, compared to $8.1 million in the prior year. Street analysts expected revenues of $39.12 million.

Adcetris product sales for the quarter was $33.2 million. Adcetris (brentuximab vedotin) was approved by the FDA last August for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates.

The drug has been also approved for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years.

CEO Clay Siegall said, "...We are also executing on a broad clinical development program of Adcetris to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies."

Total expenses for the quarter rose to $67.6 million from $43 million last year, reflecting higher selling expenses related to the launch of Adcetris, and increased research expenses.

Seattle Genetics expects full year 2012 revenues from collaboration and license agreements between $55 million and $65 million.

Analysts currently expect the company to report revenues of $196.21 million for 2012.

SGEN closed Monday on the Nasdaq at $18.96, up $0.36 or 1.96%, on a volume of 1.6 million shares. In after hours, the stock lost $1.34 or 7.07%.

For comments and feedback: contact editorial@rttnews.com

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Seattle Genetics Loss Narrows; But Stock Down - Update

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (NASDAQ:SGEN - News) today reported financial results for the fourth quarter and year ended December 31, 2011. The company also highlighted the ADCETRIS (brentuximab vedotin) product launch, recent ADCETRIS clinical data, ongoing and planned clinical development activities and upcoming milestones.

“We are pleased with the successful launch of ADCETRIS and our execution in bringing this drug to patients in need,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our commercialization initiatives continue to focus on expanding awareness of ADCETRIS among oncologists, particularly in the community setting, and ensuring an efficient reimbursement process. We are also executing on a broad clinical development program of ADCETRIS to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies. Over the past few months, we have reported encouraging data in multiple settings that support our aggressive clinical development plans, including in front-line Hodgkin lymphoma, front-line systemic ALCL and relapsed CTCL. In addition, we and our collaborators are advancing a robust pipeline of clinical and preclinical ADC programs.”

Recent Highlights

Reported clinical data on ADCETRIS (brentuximab vedotin) in multiple settings, notably demonstrating strong progress towards the company’s goal of redefining front-line therapy for Hodgkin lymphoma and mature T-cell lymphomas. ADCETRIS has not been approved for use in any of the following settings. Data were presented from:

A phase I trial evaluating sequential and concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line mature T-cell lymphomas, including systemic anaplastic large cell lymphoma (sALCL). A phase I trial evaluating concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line Hodgkin lymphoma. An investigator-sponsored phase II clinical trial of ADCETRIS in patients with cutaneous T-cell lymphoma (CTCL). Case studies of two patients with peripheral T-cell lymphoma (PTCL). A case series of patients with Hodgkin lymphoma or sALCL who received greater than 16 cycles of ADCETRIS. An analysis of the outcome of patients with relapsed Hodgkin lymphoma or sALCL who received an allogeneic stem cell transplant after treatment with ADCETRIS.

Announced multiple recent clinical trial initiations to broadly evaluate ADCETRIS in CD30-positive malignancies. Highlights include:

Initiated a phase II clinical trial in relapsed or refractory CD30-positive non-Hodgkin lymphomas, including PTCL, diffuse large B-cell lymphoma and other less common lymphoma subtypes. Initiated a phase II clinical trial in patients with CD30-positive non-lymphoma malignancies, including solid tumors, leukemia and multiple myeloma. Supported five investigator-sponsored trials (ISTs), including trials to evaluate ADCETRIS in earlier lines of Hodgkin lymphoma therapy, in older people with Hodgkin lymphoma and in other CD30-positive malignancies; expect to support multiple additional ISTs utilizing ADCETRIS to begin during 2012.

Demonstrated continued progress across product pipeline of antibody-drug conjugates (ADCs), including:

Completed enrollment in a phase I trial of single-agent SGN-75 in non-Hodgkin lymphoma and renal cell carcinoma. Completed enrollment in a phase I clinical trial of ASG-5ME for patients with pancreatic cancer; patient enrollment in a phase I clinical trial of ASG-5ME for prostate cancer is ongoing. ASG-5ME is a co-development program with Agensys, an affiliate of Astellas. Continued patient enrollment in a phase I clinical trial of ASG-22ME for solid tumors. ASG-22ME is a co-development program with Agensys, an affiliate of Agensys.

Achieved multiple milestones driven by collaborator progress under ADC agreements, including:

Preclinical milestone payments from Pfizer and Abbott. Three payments from Agensys, an affiliate of Astellas, upon exercise of options for additional exclusive antigen licenses under the companies’ ongoing ADC collaboration.

Upcoming Milestones

Planning multiple milestones for ADCETRIS and other pipeline programs, including:

Initiating a phase III clinical trial of ADCETRIS in CTCL by mid-2012. Initiating a phase III clinical trial of ADCETRIS in front-line advanced stage Hodgkin lymphoma by late 2012 to early 2013. Initiating a phase III clinical trial of ADCETRIS in front-line mature T-cell lymphomas, including sALCL, by late 2012 to early 2013. Submitting an application during the first half of 2012 to Health Canada for approval of ADCETRIS in relapsed Hodgkin lymphoma and sALCL. Millennium/Takeda expects a decision during 2012 from the European Medicines Agency (EMA) on an ADCETRIS marketing authorization application (MAA) filed by Takeda Global Research & Development Centre (Europe); the MAA filing was accepted by the EMA in June 2011. Initiating during 2012 a phase Ib clinical trial to evaluate SGN-75 in combination with everolimus, an mTOR inhibitor, for renal cell carcinoma. Submitting an investigational new drug application during 2012 for SGN-CD19A, a CD19-targeted ADC.

Fourth Quarter and Year 2011 Financial Results

Revenues in the fourth quarter of 2011 were $48.9 million, compared to $8.1 million in the fourth quarter of 2010. Fourth quarter 2011 revenues include ADCETRIS net product sales of $33.2 million. For the year 2011, revenues were $94.8 million, compared to $107.5 million for the year 2010. Revenues for the year in 2011 include $43.2 million in ADCETRIS net product sales. In addition, 2011 revenues were driven by revenue under the company’s ADCETRIS and ADC collaborations. Revenues for the year ended December 31, 2010 included approximately $70 million earned in the first half of 2010 under the dacetuzumab collaboration with Genentech that ended in June 2010.

Total costs and expenses for the fourth quarter of 2011 were $67.6 million, compared to $43.0 million for the fourth quarter of 2010. For the year 2011, total costs and expenses were $239.2 million, compared to $175.7 million for the year 2010. The planned increases in 2011 costs and expenses were primarily driven by sales and marketing activities related to the launch of ADCETRIS and higher research and development expenses, including clinical development to evaluate potential additional applications of ADCETRIS and to advance the company’s ADC pipeline programs. Under the ADCETRIS collaboration with Millennium, development costs incurred by Seattle Genetics are included in research and development expense. Joint development costs are co-funded by Millennium on a 50:50 basis. Reimbursement payments received from Millennium are recognized as revenue over the development period of the collaboration along with other development payments received, including the upfront payment and milestone payments. Non-cash, share-based compensation expense for the year 2011 was $20.0 million, compared to $14.3 million for the year 2010.

Net loss for the fourth quarter of 2011 was $27.2 million, or $0.24 per share, compared to a net loss of $34.5 million, or $0.34 per share, for the fourth quarter of 2010. Net loss in the fourth quarter of 2011 includes an $8.7 million valuation adjustment for the company’s holdings in auction rate securities, resulting in a carrying value of $5.8 million. For the year ended December 31, 2011, net loss was $152.0 million, or $1.34 per share, compared to net loss of $66.3 million, or $0.66 per share, for year ended December 31, 2010.

As of December 31, 2011, Seattle Genetics had $330.7 million in cash and investments, compared to $294.8 million as of December 31, 2010. The increase in cash and investments reflects net proceeds of approximately $168 million from the company’s public offering of common stock in February 2011 and collaboration payments received during 2011 totaling approximately $70 million.

2012 Financial Outlook

Seattle Genetics anticipates that revenues from collaboration and license agreements in 2012 will be in the range of $55 million to $65 million. These revenues will be generated from fees, milestones and reimbursements earned through the company’s ADCETRIS and ADC collaborations. The company is not providing guidance on expected revenue from ADCETRIS product sales at this time.

Total research and development and selling, general and administrative expenses in 2012 are expected to be in the range of $245 million to $270 million, approximately 35 percent of which is expected to be attributable to selling, general and administrative expenses. Operating expenses will be directed primarily towards commercialization and clinical trials of ADCETRIS, development and clinical activities for SGN-75, ASG-5ME and ASG-22ME, IND-enabling activities for SGN-CD19A, and advancing other preclinical programs. Non-cash expenses are expected to be in the range of $30 million to $33 million in 2012, primarily attributable to share-based compensation expense.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be available from Seattle Genetics’ website at http://www.seattlegenetics.com, under the Investors and News section, or by calling (877) 941-8609 (domestic) or (480) 629-9692 (international). The access code is 4509854. A replay of the discussion will be available beginning at approximately 3:30 p.m. PT today from Seattle Genetics’ website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4509854. The telephone replay will be available until 4:00 p.m. PT on Wednesday, February 15, 2012.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. ADCETRIS is approved for the treatment of patients with relapsed Hodgkin lymphoma and for the treatment of patients with relapsed sALCL.

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The FDA granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at http://www.seattlegenetics.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company’s expectations for initiation of future clinical trials, data availability from ongoing clinical trials, expectations for additional regulatory approvals and expectations for 2012 collaboration and license revenue. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the safety and/or efficacy results of our clinical trials of ADCETRIS affect the commercial potential or ability to initiate future clinical trials of ADCETRIS. We may also be delayed in our planned trial initiations and regulatory submissions and approvals for reasons outside of our control. We may also fail to receive milestone payments under our collaborations and experience unforeseen increased expenses or unexpected reductions in revenues. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s 10-Q for the quarter ended September 30, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

  Seattle Genetics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)     December 31,
2011   December 31,
2010 Assets Cash, cash equivalents, short and long term investments $ 330,696 $ 294,840 Other assets   94,520   35,096 Total assets $ 425,216 $ 329,936   Liabilities and Stockholders' Equity Accounts payable and accrued liabilities $ 53,048 $ 25,783 Deferred revenue and long-term liabilities 153,319 142,635 Stockholders' equity   218,849   161,518 Total liabilities and stockholders' equity $ 425,216 $ 329,936     Seattle Genetics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)    

Three months ended
December 31,

  Twelve months ended
December 31,   2011       2010     2011       2010   Revenues Net product sales $ 33,194 $ - $ 43,241 $ - Collaboration and license agreement revenues   15,693     8,146     51,537     107,470   Total revenues   48,887     8,146     94,778     107,470   Costs and expenses Cost of sales 2,391 - 3,115 - Research and development 40,239 32,520 163,396 146,410 Selling, general and administrative   24,954     10,522     72,659     29,258   Total costs and expenses   67,584     43,042     239,170     175,668   Loss from operations (18,697 ) (34,896 ) (144,392 ) (68,198 ) Investment income (loss), net   (8,468 )   350     (7,638 )   1,933   Net loss $ (27,165 ) $ (34,546 ) $ (152,030 ) $ (66,265 )   Basic and diluted net loss per share $ (0.24 ) $ (0.34 ) $ (1.34 ) $ (0.66 )  

Weighted-average shares used in computing basic and diluted net loss per share

  115,064     101,450     113,098     101,055    

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Seattle Genetics Reports Fourth Quarter and Year 2011 Financial Results

Heart-Attack Damage Heals After Stem Cell Treatment

Feb. 13, 2012 -- A new stem cell treatment resurrects dead, scarred heart muscle damaged by a recent heart attack.

The finding, just in time for Valentine's Day, is the clearest evidence yet that literally broken hearts can heal. All that's needed is a little help from one's own heart stem cells.

"We have been trying as doctors for centuries to find a treatment that actually reverses heart injury," Eduardo Marban, MD, PhD, tells WebMD. "That is what we seem to have been able to achieve in this small number of patients. If so, this could change the nature of medicine. We could go to the root of disease and cure it instead of just work around it."

Marban, director of the Cedars-Sinai Heart Institute in Los Angeles, led the study. He invented the "cardiosphere" culture technique used to create the stem cells and founded the company developing the treatment.

It's the first completed, controlled clinical trial showing that scarred heart tissue can be repaired. Earlier work in patients with heart failure, using different stem cells or bone-marrow stem cells, also showed that the heart can regenerate itself.

"These findings suggest that this therapeutic approach is feasible and has the potential to provide a treatment strategy for cardiac regeneration after [heart attack]," write University of Hong Kong researchers Chung-Wah Siu and Hung-Fat Tse. Their editorial accompanies the Marban report in the Feb. 14 advance online issue of The Lancet.

Heart Regenerates With Stem Cell Help

The stem cells don't do what people think they do, Marban says.

It's been thought that the stem cells multiply over and over again. In time, they were supposed to be turning themselves and their daughter cells into new, working heart muscle.

But the stem cells seem to be doing something much more amazing.

"For reasons we didn't initially know, they stimulate the heart to fix itself," Marban says. "The repair is from the heart itself and not from the cells we give them."

Exactly how the stem cells do this is a matter of "feverish research" in Marban's lab.

The phase I clinical trial enrolled 25 patients who had just had a heart attack. On average, each patient had lost a quarter of his heart muscle. MRI scans showed massive scars.

Eight patients got standard care. The other 17 received increasing infusions of what Marban calls stem cells. The cells were grown in the lab from tiny amounts of heart cells taken from the patients' own hearts via biopsy. Six to 12 weeks later, the cells were infused directly back into patients' hearts.

A year later, the mass of scar tissue in the treated patients' hearts got 42% smaller. And healthy heart muscle increased by 60%. No such regeneration was seen in the patients who got standard care.

Because all of the patients were doing relatively well, there was no dramatic difference in clinical outcome. However, treated patients had a bit better exercise endurance.

"This discovery challenges the conventional wisdom that, once established, cardiac scarring is permanent and that, once lost, healthy heart muscle cannot be restored," Marban and colleagues conclude.

Read this article:
Scarred Hearts Healed After Heart Attack

The damage caused by a heart attack was healed by using stem cells gathered from the patient’s own heart in a small trial written up in The Lancet journal, according to the BBC.

The preliminary study was carried out at the Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, and involved 25 patients who had suffered heart attacks recently, reported The Los Angeles Times.

Seventeen of the subjects in the study were given infusions of stem cells “cultured from a raisin-sized chunk of their own heart tissue,” while the other eight were given standard care, reported The LA Times.

The size of the scars on heart tissue damaged by a heart attack decreased in size from 24 percent of the heart to 12 percent of the heart, said Dr. Eduardo Márban, the lead researcher in the study. He wrote to The LA Times in an email that the most surprising aspect of the findings was the fact that the heart could regrow healthy tissue.

More on GlobalPost: Global malaria deaths twice as high as estimated, Lancet study says

The study used a procedure invented by Márban to isolate heart stem cells from healthy tissue from each patient’s heart, and then grow millions of new cells in a petri dish, according to CNN. The patients who received the stem cell treatment either had 12 million or 25 million such cells injected back into their hearts.

Deepak Shrivastava, the director of the Gladstone Institute of Cariovascular Disease based in San Francisco, told Bloomberg, “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

Márban told CNN, “If we can regenerate the whole heart, then the patient would be completely normal. We haven’t fulfilled that yet, but we’ve gotten rid of half the injury, and that’s a good start."

More on GlobalPost: Study links high calorie intake with memory loss

http://www.globalpost.com/dispatch/news/health/120213/stem-cells-used-heal-heart-attack-damage

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Stem cells used to heal heart attack damage

WALKER, Mich. (WOOD) - Dogs who received the first in-clinic stem cell therapy in West Michigan returned to the vets who treated them Monday morning.

Boris and Natasha returned to Kelley's Animal Clinic for their 60-day checkup after receiving stem cell treatment in December 2011.

Dr. James Kelley and his staff of vets removed fat tissue from the dogs and activated it with an enzyme before injecting it into their back legs.

This adult animal stem cell technology is different from the controversial embryonic stem cell therapy.

Kelley said both dogs are doing amazingly well and that the procedure has done more than just help their arthritis.

"We're finding that not only the joints are affected, the rest of the animal is affected as well," said Kelley. "The skin is better. The attitude in these dogs is much improved."

Kelley and his staff have done 16 stem cell treatments since the first on Boris and Natasha, and he said all the dogs are showing signs of improvement after a short period of time.

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Dogs who got stem cell therapy are well

Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University (43935MF) in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Scarred Hearts Can Be Mended With Novel Stem Cell Therapy, Study Finds

February 14, 2012, 12:22 AM EST

By Ryan Flinn

Feb. 14 (Bloomberg) -- Stem cells grown from patients’ own cardiac tissue can heal damage once thought to be permanent after a heart attack, according to a study that suggests the experimental approach may one day help stave off heart failure.

In a trial of 25 heart-attack patients, 17 who got the stem cell treatment showed a 50 percent reduction in cardiac scar tissue compared with no improvement for the eight who received standard care. The results, from the first of three sets of clinical trials generally needed for regulatory approval, were published today in the medical journal Lancet.

“The findings in this paper are encouraging,” Deepak Srivastava, director of the San Francisco-based Gladstone Institute of Cardiovascular Disease, said in an interview. “There’s a dire need for new therapies for people with heart failure, it’s still the No. 1 cause of death in men and women.”

The study, by researchers from Cedars-Sinai Heart Institute in Los Angeles and Johns Hopkins University in Baltimore, tested the approach in patients who recently suffered a heart attack, with the goal that repairing the damage might help stave off failure. While patients getting the stem cells showed no more improvement in heart function than those who didn’t get the experimental therapy, the theory is that new tissue regenerated by the stem cells can strengthen the heart, said Eduardo Marban, the study’s lead author.

“What our trial was designed to do is to reverse the injury once it’s happened,” said Marban, director of Cedars- Sinai Heart Institute. “The quantitative outcome that we had in this paper is to shift patients from a high-risk group to a low- risk group.”

Minimally Invasive

The stem cells were implanted within five weeks after patients suffering heart attacks. Doctors removed heart tissue, about the size of half a raisin, using a minimally invasive procedure that involved a thin needle threaded through the veins. After cultivating the stem cells from the tissue, doctors reinserted them using a second minimally invasive procedure. Patients got 12.5 million cells to 25 million cells.

A year after the procedure, six patients in the stem cell group had serious side effects, including a heart attack, chest pain, a coronary bypass, implantation of a defibrillator, and two other events unrelated to the heart. One of patient’s side effects were possibly linked to the treatment, the study found.

While the main goal of the trial was to examine the safety of the procedure, the decrease in scar tissue in those treated merits a larger study that focuses on broader clinical outcomes, researchers said in the paper.

Heart Regeneration

“If we can regenerate the whole heart, then the patient would be completely normal,” Marban said. “We haven’t fulfilled that yet, but we’ve gotten rid of half of the injury, and that’s a good start.”

While the study resulted in patients having an increase in muscle mass and a shrinkage of scar size, the amount of blood flowing out of the heart, or the ejection fraction, wasn’t different between the control group and stem-cell therapy group. The measurement is important because poor blood flow deprives the body of oxygen and nutrients it needs to function properly, Srivastava said.

“The patients don’t have a functional benefit in this study,” said Srivastava, who wasn’t not involved in the trial.

The technology is being developed by closely held Capricor Inc., which will further test it in 200 patients for the second of three trials typically required for regulatory approval. Marban is a founder of the Los Angeles-based company and chairman of its scientific advisory board. His wife, Lisa Marban, is also a founder and chief executive officer.

--Editors: Angela Zimm, Andrew Pollack

-0- Feb/13/2012 22:32 GMT

To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Scarred Hearts Can Be Mended With Stem Cell Therapy, Study Shows

COLUMBIA, SC (WIS) - Cutting-edge arthritis treatment for our four-legged family members is now available in Columbia.

Banks Animal Hospital is the first in the area to offer in-house Stem Cell therapy. It uses your pets own body to heal itself.

Take 13-year-old Maggie, for example. The energetic pup has a limp that usually keeps her from jumping or going up stairs.

"Today when everybody's out there filming her little limp it's not as pronounced because she wants to please," said Maggie's owner, Beth Phibbs. "She's just a great dog."

But a great attitude wasn't enough to repair a bad case of cervical spine arthritis.

So Monday, Beth brought Maggie to Banks Animal Hospital for the Stem Cell therapy. Like many, Beth had never heard of Stem Cell work in animals. "Until Dr. Banks mentioned it to me I was like, beg your pardon?"

"There's no down side, no side effects because you're using your own cells," said Dr Ken Banks.

Banks and his staff first gather some of Maggie's blood and fat. Both are good places to find the repair cells they're after. Adult stem cells, not the controversial embryonic kind, are then separated and spun down.

"The repair system in Maggie's body has failed," said Jason Richardson of MediVet-America. "It's fallen asleep at the wheel, we're taking these repair cells, activating them so a chronic condition like osteo arthritis to Maggie will now be an acute illness."

This kind of treatment used to take days with material being shipped across the country, but now it can be done in hours.

"The ability to do it same day, convenience, the ability to do it in clinic saves a lot of money to the doctor which he can then pass on to the patient," said Richardson.

The treatment will still run you around $2,000, but Richardson says that's half of what the similar treatment use to cost.

When it's over, Maggie should be able to live out her life pain and drug free -- something Phibbs is looking forward to.

"I'm hoping in a couple of weeks she's gonna have a new lease on life," said Phibbs.

Copyright 2012 WIS. All rights reserved.

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Vet offers stem cell therapy for dogs

MONDAY, Feb. 13 (HealthDay News) -- Stem cell therapy's promise for healing damaged tissues may have gotten a bit closer to reality. In a small, early study, heart damage was reversed in heart-attack patients treated with their own cardiac stem cells, researchers report.

The cells, called cardiosphere-derived stem cells, regrew damaged heart muscle and reversed scarring one year later, the authors say.

Up until now, heart specialists' best tool to help minimize damage following a heart attack has been to surgically clear blocked arteries.

"In our treatment, we dissolved scar and replaced it with living heart muscle. Such 'therapeutic regeneration' has long been the holy grail of cell therapy, but had never been accomplished before; we now seem to have done it," said study author Dr. Eduardo Marban, director of the Cedars-Sinai Heart Institute in Los Angeles.

However, outside experts cautioned that the findings are preliminary and the treatment is far from ready for widespread use among heart-attack survivors.

The study, published online Feb. 14 in The Lancet, involved 25 middle-aged patients (average age 53) who had suffered a heart attack. Seventeen underwent stem cell infusions while eight received standard post-heart attack care, including medication and exercise therapy.

The stem cells were obtained using a minimally invasive procedure, according to the researchers from Cedars-Sinai and the Johns Hopkins Hospital in Baltimore.

Patients received a local anesthetic and then a catheter was threaded through a neck vein down to the heart, where a tiny portion of muscle was taken. The sample provided all the researchers needed to generate a supply of new stem cells -- 12 million to 25 million -- that were then transplanted back into the heart-attack patient during a second minimally invasive procedure.

One year after the procedure, the infusion patients' cardiac scar sizes had shrunk by about half. Scar size was reduced from 24 percent to 12 percent of the heart, the team said. In contrast, the patients receiving standard care experienced no scar shrinkage.

Initial muscle damage and healed tissue were measured using MRI scans.

After six months, four patients in the stem-cell group experienced serious adverse events compared with only one patient in the control group. At one year, two more stem-cell patients had a serious complication. However, only one such event -- a heart attack -- might have been related to the treatment, according to the study.

In a news release, Marban said that "the effects are substantial and surprisingly larger in humans than they were in animal tests."

Other experts were cautiously optimistic. Cardiac expert Dr. Bernard Gersh, a professor of medicine at Mayo Clinic, is not affiliated with the research but is familiar with the findings.

"This study demonstrates that it is safe and feasible to administer these cardiac-derived stem cells and the results are interesting and encouraging," he said.

Another specialist said that while provocative and promising, the findings remain early, phase-one research. "It's a proof-of-concept study," said interventional cardiologist Dr. Thomas Povsic, an assistant professor of medicine at the Duke Clinical Research Institute, in Durham, N.C.

And Dr. Chip Lavie, medical director of Cardiac Rehabilitation and Prevention at the John Ochsner Heart and Vascular Institute, in New Orleans, also discussed the results. He said that while the study showed that the cardiac stem cells reduced scar tissue and increased the area of live heart tissue in heart attack patients with moderately damaged overall heart tissue, it did not demonstrate a reduction in heart size or any improvement in the heart's pumping ability.

"It did not improve the ejection fraction, which is a very important measurement used to define the overall heart's pumping ability," Lavie noted. "Certainly, much larger studies of various types of heart attack patients will be needed before this even comes close to being a viable potential therapy for the large number of heart attack initial survivors."

Povsic concurred that much larger studies are needed. "The next step is showing it really helps patients in some kind of meaningful way, by either preventing death, healing them or making them feel better."

It's unclear what the cost will be, Povsic added. "What society is going to be willing to pay for this is going to be based on how much good it ends up doing. If they truly regenerate a heart and prevent a heart transplant, that would save a lot money."

Marban, who invented the stem cell treatment, said the while it would not replace bypass surgery or angioplasty, "it might be useful in treating 'irreversible' injury that may persist after those procedures."

As a rough estimate, he said that if larger, phase 2 trials were successful, the treatment might be available to the general public by about 2016.

More information

The U.S. National Heart, Lung, and Blood Institute describes current heart attack treatment.

Read the original here:
Stem Cell Treatment Might Reverse Heart Attack Damage

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of third patient in its Phase 1/2 trial for Stargardt’s macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Monday (Feb. 6) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and retina division chief at UCLA’s Jules Stein Eye Institute. The outpatient transplantation surgery was performed successfully and the patient is recovering uneventfully.

“With the treatment of this third Stargardt’s patient at Jules Stein Eye Institute, we have now completed the treatment of the first cohort of patients under our clinical protocol for phase I/II of our U.S. SMD trial,” said Gary Rabin, chairman and chief executive officer of ACT. “We will continue to regularly monitor the three SMD patients in this trial, and by early spring anticipate review of their progress and safety-related data by the Data and Safety Monitoring Board (DSMB). With approval of the DSMB, we would then advance to the next cohort of patients and administer a higher dosage of RPE cells. In the context of all three trials we have running, this patient is the fifth person worldwide to be treated with our hESC-derived RPE cells. To date, there have been no complications or side effects due to the RPE cells, and we remain cautiously optimistic that our ongoing clinical programs will demonstrate the safety and tolerability of ACT’s stem cell-derived RPE cells.”

Each of the three clinical trials being undertaken by the company in the U.S. and Europe will enroll 12 patients, with cohorts of three patients each in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with SMD or dry age-related macular degeneration (dry AMD) at 12 months, the study’s primary endpoint. Preliminary results relating to both early safety and biological function for the first two patients in the United States, one SMD patient and one dry AMD patient, were recently reported in The Lancet. On January 20, 2012, the first SMD patient to be enrolled in the Company’s U.K. clinical trial was treated at Moorfields Eye Hospital in London.

Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.

About Stargardt's Disease

Stargardt’s disease or Stargardt’s Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2010. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.

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ACT Announces Third Patient with Stargardt’s Disease Treated in U.S. Clinical Trial with RPE Cells Derived from ...