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Archive for the ‘Regenerative Medicine’ Category

Being bionic: the future of regenerative medicine – Toronto Star

Saturday, April 17th, 2021

Six decades ago, two researchers at the Ontario Cancer Institute at Princess Margaret Hospital made a startling discovery. James Till and Ernest McCulloch had found transplantable stem cells, special building block cells that have the ability to grow into any kind of human tissue.

Till and McCulloch were studying the effects of radiation at the time, but their work set off an explosion of research aimed at harnessing stem cells to treat all kinds of diseases and conditions. Subsequent breakthroughs in stem cell therapy have been used to treat more than 42,000 patients for hemophilia, restore sight to blind mice and even help a 78-year-old man regrow the end of a sliced-off fingertip. And researchers are still unlocking what might be possible.

The potential of regenerative medicine is astounding, says Michael May, president of the Centre for Commercialization of Regenerative Medicine (CCRM), a Toronto non-profit that helps bring new stem cell therapies and other regenerative medicine technologies to market. Researchers are harnessing stem cells to repair, replace or regenerate human cells, tissues and organs with the aim of improving treatments for conditions ranging from diabetes to blindness to heart failure and cancer.

More recent advances most notably Shinya Yamanakas Nobel Prize-winning 2012 discovery that regular adult tissue cells can be reprogrammed to become stem cells again, therefore endowing them with the ability to become any type of cell in the body have also ushered in a new wave of regenerative medicine research and what May calls a global race to bring newly possible cell therapies to market.

As president of CCRM, Mays job is to help move some of that research from the laboratory into the real world. Over the last decade, his organization has helped 11 companies come to market with regenerative medicine technologies, such as Montreals ExCellThera, which provides new therapeutic options for patients who suffer from myeloid leukemia and lack a traditional bone marrow donor.

While the last decade was defined by research and technological breakthroughs, May says the next decade will be all about lowering manufacturing costs and tackling patient access bottlenecks. Last November, CCRM announced that it would partner with McMaster Innovation Park in Hamilton to create Canadas first commercial-scale factory for making cells, which will be able to produce billions of cells enough to treat thousands of patients per week.

Weve just scratched the surface of whats possible in regenerative medicine, May says. He envisions a time when well eventually use these techniques not just to cure and fix human bodies, but also make them better. Now we can make cells, we can design them by genetically engineering them to do things that they naturally do, but that can be more than nature designed, says May. He says the editing of human traits in this way could eventually augment human abilities to such an extent that theyre unrecognizable.

Biomaterials are another technology that could transform regenerative medicine. Before joining CCRM, May himself helped found a Toronto biomaterials startup called Rimon Therapeutics, which developed a smart dressing for chronic wounds that used special polymers to support the bodys natural healing process. Similar advanced biomaterials could eventually be used in combination with cell therapies to not just fight aging and degeneration, but to also prevent it entirely, and even improve upon the human bodys natural baseline health.

Fifty years from now if theres some sort of blindness, well have a lens on the eye that will automatically focus and react or change as the eye ages, he says.

Nick Zarzycki is a freelancer who writes about technology for MaRS. Torstar, the parent company of the Toronto Star, has partnered with MaRS to highlight innovation in Canadian companies.

Disclaimer This content was produced as part of a partnership and therefore it may not meet the standards of impartial or independent journalism.

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Russell Health Honored in Global Business Leaders Magazine’s ’20 Leading Companies of the Year 2021′ – PRNewswire

Saturday, April 17th, 2021

WILLOWBROOK, Ill., April 14, 2021 /PRNewswire/ --Based in Willowbrook, Illinois, Russell Health is a national marketer and distributor of specialty medical products and services. Russell Health, Inc., was recently awarded as #2 in Global Business Leaders Magazine's "20 Leading Companies of the Year 2021." Based in Atlanta, Georgia, Global Business Leaders Magazine's mission 'focuses on exalting the contribution of leaders who have been the emissary for their respective industries.' Their 2021 Top 20 list features a collection of leaders across industries like medical technology, finance, marketing, blockchain solutions, industrial fabrication, and more. Read more here

Russell Health's full-page feature presents an article titled, "Russell Health: A Mini Amazon for Regenerative Medicine." It discusses the history of Russell Health Inc., ongoing research and benefits of Stem Cell Recruitment Therapy, and well-defined commentary about how Russell Health has redefined the medicine market, even during a global pandemic. Read Russell Health's featured article here

About Russell Health: Russell Health and its partners have distributed regenerative therapy products nationwide and achieved profound clinical outcomes in multiple therapeutic areas including cosmetics, wound care, pain management, podiatry, orthopedic, dentistry and gynecology. With their partners and suppliers, they work to provide innovative life-changing and sustaining products and therapies to patients and healthcare providers around the world.

Russell Health's Stem Cell Recruitment Therapyproducts are intended for homologous use to help repair, reconstruct or supplement the patient's joints or soft tissue as well as help to increase mobility while decreasing pain. These responsibly sourced acellular tissue allografts are helping people of all ages to recover from injuries and get their life back.

Pull Quotes:

"We have built a mini-Amazon for regenerative medicine." (Ryan Salvino, CEO of Russell Health)

"Our ultimate goal from the beginning has been to help people by providing safe alternatives to risky procedures and expensive treatments while offering an alternative to synthetic drugs and embracing more holistic and organic products. We want to continue to become the number one supplier of regenerative medicine in the U.S." (Jonathan Benstent, Vice President of Russell Health)

"While the pandemic caused major disruption throughout the industry, it managed to pivot patients and physicians toward alternative treatments such as Stem Cell Recruitment Therapy. This demand can help in further enhancing the discovery of new applications for Stem Cell Recruitment Therapy products. As a result, Russell Health is working with some of the top leaders in the regenerative medicine field to continue to grow and provide innovative products to customers and their patients." (Global Business Leaders Magazine)

Visit Russell Health online to learn more about Stem Cell Recruitment Therapy. For media inquiries or to contact the Russell Health team directly. Please visit http://www.russellhealth.comor email [emailprotected].

Contact: Veronica Bennett

Address & Phone: 621 Plainfield Rd., Willowbrook, IL 60527; 844-249-6200

Email: [emailprotected]

Online: http://www.russellhealth.com

Social Media: http://www.linkedin.com/company/russell-health:: https://www.facebook.com/russellhealthinc:: https://www.instagram.com/russellhealth:: https://twitter.com/health_russell

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Cellino Biotech developing tech to help scale stem cell therapies – MedCity News

Saturday, April 17th, 2021

In response to emailed questions, Cellino Biotech CEO and Co-founder Dr. Nabiha Saklayen, talked about the formation of the company and its goal to make stem cell therapies more accessible for patients.

Why did you start this company?

I see a huge need to develop a technology platform to enable the manufacture of cell therapies at scale. We recently closed a $16 million seed financing round led by Khosla Ventures and The Engine at MIT, with participation from Humboldt Fund. Cellino is on a mission to make personalized, autologous cell therapies accessible for patients. Stem cell-derived regenerative medicines are poised to cure some of the most challenging diseases within this decade, including Parkinsons, diabetes, and heart disease. Patient-specific cells provide the safest, most effective cures for these indications. However, current autologous processes are not scalable due to extensive manual handling, high variability, and expensive facility overhead. Cellinos vision is to make personalized regenerative medicines viable at large scale for the first time.

How did you meet your co-founders?

Nabiha Saklayen.

I met my co-founder Marinna Madrid in my Ph.D. research group. We had worked together for many years and had a fantastic working relationship. I then met our third co-founder Matthias Wagner through a friend. Matthias had built and run three optical technology companies in the Boston area and was looking to work with a new team. I was thrilled when we decided to launch the startup together at our second meeting. Matthias built the first Cellino hardware systems in what I like to call Matthias garage. In parallel, I was doing hundreds of expert interviews with biologists in academia and industry, and it started to narrow down our potential applications very quickly. Marinna was doing our first experiments with iPSCs. We iterated rapidly on building new versions of the hardware based on the features that were important to industry experts, such as single-cell precision and automation. Its incredible to witness our swift progress as a team.

What specific need or pain point are you seeking to address in healthcare/life sciences?

In general, autologous therapies are safer for patients because they do not require immunosuppression. The next iteration of cell therapies would use patient-specific stem cells banked ahead of time. Anytime a patient needs new cells, such as blood cells, neurons, or skin cells, we would generate them from a stem cell bank.

Today, patient-specific stem cell generation is a manual and artisanal process. A highly skilled scientist sits at a bench, looks at cells by eye, and removes unwanted cells with a pipette tip. Many upcoming clinical trials are using manual processes to produce stem cells for about ten to twenty patients.

At Cellino, we are converging different disciplines to automate this complex process. We use an AI-based laser system comes to remove any unwanted cells. By making stem cells for every human in an automated, scalable way, we are working towards our mission at Cellino to democratize personalized regenerative medicine.

What does your technology do? How does it work?

Cellinos platform combines label-free imaging and high-speed laser editing with machine learning to automate cell reprogramming, expansion, and differentiation in a closed cassette format, enabling thousands of patient samples to be processed in parallel in a single facility.

In general, autologous, patient-specific stem cell-derived therapies do not require immunosuppression and are safer for patients. Today, patient-specific stem cells are made manually, by hand. To scale the stem cell generation process, Cellino converges different disciplines to automate this complex process. We train machine learning algorithms to characterize cells before our AI-based laser system removes any unwanted cells. By making stem cells for every human in an automated, scalable way, our mission at Cellino is to democratize personalized regenerative medicine. Thats why our vision statement is Every human. Every cell.

Whats your background in healthcare? How did you get to where you are today?

When I arrived at Harvard University for my Ph.D. in physics, I wanted to be closer to real-world applications. Biology is inherently complex and beautiful, and I was interested in developing new physics-based tools to engineer cells with precision. During my Ph.D., I invented new ways to edit cells with laser-based nanomaterials. I collaborated with many brilliant biology groups at Harvard, including the Rossi, Scadden, and Church labs. Working closely with them convinced me that lasers offer a superior solution to editing cells with high precision. That realization compelled me to launch Cellino.

Do you have clinical validation for your product?

Our immediate goal for the next year is to show that our platform can produce personalized, high-quality, R&D-grade stem cells for different patients, which has not been established in an automated manner in the regenerative medicine industry so far. There is significant patient-to-patient variability in manual cell processing, which we eliminate with our platform.

Photo: Urupong, Getty Images

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Organicell and Oklahoma State University Enter Into Agreement To Study Zofin in Respiratory Diseases Caused By Virus Infections Of Pandemic Potential…

Saturday, April 17th, 2021

MIAMI--(BUSINESS WIRE)-- Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced that it has entered into an agreement with Oklahoma State University to evaluate Zofin for the treatment of respiratory diseases caused by virus infections of pandemic potential. This study site follows the Companys earlier announcement of the agreement reached with the Centers for Disease Control and Prevention (CDC) to conduct research to determine the anti-inflammatory and anti-infective effectiveness of Zofin in experimental models of influenza infection.

The ongoing COVID-19 pandemic has infected over 5 million people globally and caused over 300,000 case fatalities in 188 countries. Additionally, the CDC estimates between 39-55 million influenza related illnesses and more than 60,000 deaths due to influenza. The observed illnesses and case fatalities are primarily due to the lack of known effective antivirals and prophylactic vaccines to attenuate the viruses.

In this agreement, Organicell will supply Oklahoma State University with its lead compound, Zofin, which is an acellular material derived from human amniotic fluid. This extracellular vesicle-derived nanoparticle-based therapeutic will be assessed on its ability to induce antiviral and/or immunomodulatory activity against virus infections of pandemic potential as there is an unmet need for non-toxic and effective therapeutic approaches to deal with current and imminent pandemics.

Organicell is dedicated to continuing regenerative therapy research for diseases with unmet needs. We are thrilled to be partnering with Oklahoma State University and the CDC on the study of Zofin for viral infections of pandemic proportions. A year into the pandemic has shown us the importance of research aimed at the development of biologics, said Albert Mitrani, CEO of Organicell.

We are excited to partner with Oklahoma State University and the CDC to investigate how the extracellular vesicle-derived nanoparticles, in Zofin, will impact antiviral and/or immunomodulatory activity of viral infections with pandemic potential. Dr. Mari Mitrani, Chief Science Officer of Organicell.

About Zofin:

Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

ABOUT ORGANICELL REGENERATIVE MEDICINE, INC.

Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR) is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The Companys proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. To learn more, please visit https://organicell.com/.

FORWARD-LOOKING STATEMENTS

Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the Securities Act), the Securities Exchange Act of 1934, as amended (the Exchange Act), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as will, believes, expects, potential or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Companys periodic reports that are filed with the SEC and available on the SECs website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.

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Lessons learned: W&M students working in healthcare reflect on a year of pandemic – William & Mary News

Saturday, April 17th, 2021

Scribe and student: For the past five years, Brooke Ford has worked her way through college as an emergency room scribe at a few local hospitals. In her senior year at William & Mary, as the COVID-19 pandemic ravaged the nation, she managed medical scribes at two hospitals. Courtesy photo

by Adrienne Berard | April 16, 2021

For the better part of the past year, Brooke Fords return home from work has been an exercise in mitigating the spread of a potentially deadly pathogen.

She pulls off all her personal protective equipment, washes her hands, showers off, changes clothes, throws out any food or drink she may have touchedand greets her family.

I know a lot of people who were scared to even live with their families when they're working in a hospital room, because they didn't want to bring it home, said Ford, a William & Mary health sciences major who graduated in December.

For the past five years, Ford has worked her way through college as an emergency room scribe at a few local hospitals. In her senior year, as the COVID-19 pandemic ravaged the nation, she managed medical scribes at hospitals in Hampton and Newport News.

A scribe is responsible for recording the details of a patient's clinical history, current health issues, diagnoses and any medical procedures that are performed or prescribed, Ford explained. The scribe serves a vital role of being the ears and eyes in the room, so that a physician can focus squarely on treating the patient.

I lead teams at two hospitals, Ford said. During the pandemic, that has been really difficult because I had people that didn't want to come to work, which, I mean, it's scary. I dont blame them for that, but we had to learn to balance the fear and the need to do our jobs.

That balance between fear and the vital work ahead is one that has been familiar to healthcare professionals throughout the world this past year. For students graduating into the industry, the landscape has shifted dramatically, revealing fault lines in Americas healthcare system that these newest professionals are uniquely positioned to witness, study and address.

Matthew Tucker 22 started volunteering as an EMT with the Williamsburg Volunteer Fire Department his freshman year at William & Mary. Hes now the collegiate lieutenant, responsible for managing and training college students on the operations of emergency medical services provided by the local fire station.

I help train incoming college students on operations of the fire station, the ambulance, the equipment, all of those sorts of thing, he said.

This winter, as COVID-19 case numbers surged nationwide, Tucker was one of a handful of student volunteers who worked as first responders, supporting the career EMT staff at the fire station.

I know that the staff paramedics were especially burnt out. They couldnt trade shifts, they couldn't utilize their vacation time, so we were able to provide resources to support them in getting some relief, Tucker said. As students, we were able to see things that we haven't seen for 100 years. The amount of learning that can be done in that environment is astounding, and it has given me tremendous perspective on my future medical path.

Tucker said, as a student concentrating in public health, hes been particularly aware of the health disparities in the community he serves. It was immediately clear to him that the vast majority of emergency calls were coming from low-income neighborhoods.

I believe that we're often responding to places where the healthcare system has failed, where we are their primary care provider, a call to 911, taking them to the emergency room, he said. These disparities have always been there, but we're seeing them very plainly now, how socioeconomic status, job accessibility, food insecurity, all these different things affect someone's risk to COVID and ultimately affect people's health status. Weve not always been in tune to seeing that before the pandemic.

Sophie Kopec 21 spent this past summer analyzing data on experimental, early-stage clinical trials for the cell and gene medicine division of the non-profit Alliance for Regenerative Medicine. Explaining what she does is a key part of the job.

Its such an up-and-coming field that there are negative trigger words, all this stigma, especially around cell therapy, she said. So, part of my job was to look at data from all of these regenerative medicine clinical trials to identify the most promising ones. Then we translate that data into the commercial field to help show consumers that this is real, valid, verified science. Its not some kind of scam.

Kopec describes regenerative medicine as using the body's own functions to train it to fix itself.

For example, take gene therapy, in that case you have editing technology like CRISPR, where you can go in and actually edit the bodys genes and reprogram them to respond to the treatment and then body essentially heals itself, she said.

Kopec entered William & Mary with her sights hard-set on chemistry. It wasnt until her junior year, when she was working her way down the list of general education requirements, that she enrolled in a Foundations of Epidemiology course with Assistant Professor of Kinesiology and Health Sciences Carrie Dolan.

After taking that class, everything changed and I shifted my focus to public health, Kopec said. Ill always be grateful to William & Mary for that. I came into school with tunnel vision. I was going to go to med school and work in scrubs or in a lab, but my education broadened my perspective. Actually, it did more than that, it revealed my passion to me. Had I not been forced off track by the general education requirements, I would have never found this incredible spark and pursued this passion that I have now.

Graduation can be an anxiety-inducing milestone, even in the best of times. For those entering careers in the healthcare industry, the uncertainty of the pandemic has added another layer of stress and hope for overcoming the challenges of the past.

Next month, Kopec starts her new job as a clinical research coordinator at Children's National Hospital in D.C. Shell be serving in the neuro-oncology unit, working with children who have not responded to traditional therapy measures and providing experimental treatment that is often the last and only resort left. Her first in-person day at the hospital is scheduled for June 1.

Well be doing clinical trials that offer more therapeutic approaches to treating these late-stage tumors, she said. Even if the end result for some of these patients may be death, at least we know that we did everything in our power to help them and give them another chance to keep fighting and have another opportunity at life.

When Ford began her studies at William & Mary, she was interested in emergency medicine. She wanted to learn to respond in crisis to keep people alive. Now, after all she has witnessed in this year of pandemic, she hopes to study palliative care. She wants to learn how to help people live and die with dignity.

In medical school, they teach you how to save people, but what happens when you cant save them, when there is nothing else you can do? she said. Its not a conversation were often prepared for, but its so important. In a lot of ways, how can you know how you want to live if you don't know how you want to die?

So many families this year have had to make those choices for family members and they don't know what choices those family members would want to make for themselves, she added. Theyve had to make those choices, because those conversations haven't been had. I want to be there to help have those hard conversations.

After graduating from William & Mary, Tucker plans to go to medical school to obtain Master of Public Health and Medical Doctor degrees. He plans to work primarily with people experiencing homelessness and be able to treat them holistically.

If theres one main thing that I think that weve all learned this pandemic, its that health is incredibly complex, Tucker said. Truly, everything that we do impacts our health, every societal factor, institutional factor, personal factor that's put into place influences somebodys health.

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First in the nation, FDA-approved Phase II mesenchymal stem cell therapy for Parkinson’s disease begins – Newswise

Saturday, April 17th, 2021

Newswise A Phase II clinical trial to assess mesenchymal adult stem cells as a disease-modifying therapy for Parkinson's disease has been launched at The University of Texas Health Science Center at Houston (UTHealth).

"Studies have shown mesenchymal stem cells can migrate to the sites of injury and respond to the environment by secreting several anti-inflammatory and growth factor molecules that can restore tissue equilibrium and disrupt neuronal death," said Mya C. Schiess, MD, professor in the Department of Neurology and director and founder of the movement disorder subspeciality clinic and fellowship program at McGovern Medical School at UTHealth. "The stem cells interact directly with the immune cells, leading to an anti-inlammatory state that allows a restorative process to take place."

Safety and tolerability results, assessed on a previous trial, were recently published in the journal Movement Disorders. The Phase I study showed that there were no serious adverse reactions related to the stem cell influsion and no immunological reactions to the cells, which come from the bone marrow of a healthy adult donor. The study enrolled 20 patients with mild to moderate disease, who were infused with one of four different dosages and monitored for a year. Additionally, researchers reported a reduction in preripheral inflammatory markers and a reduction in motor symptoms.

Parkinson's diease is the second most common neurodegenerative disease, affecting more than a million Americans. It is also the fastest-growning of the neurodegenerative diseases, with more than 60,000 new cases identified every year. It is predicted that by 2040, Parkinson's disease will affect 17.5 million people worldwide.

Research has shown that one of the forces playing a critical role in the diease's development and progression is a chronic neuroinflammatory process that damages the brain's microenvironment and alters its healthy equilibrium. Inflammatiion perpetuates the neurodegenration in the brain areas that control movement, causing the tremors, imbalance, loss of speech, slowness, and other motor impairments.

The randomized, double-blind, placebo-controlled Phase II trial will investigate the safest and most effective number of repeat doses of stem cells to slow the progression of Parkinson's disease. The study will enroll 45 patients, ages 50 to 79, who will receive three infusions of either placebo or stem cell therapy at three-month intervals and will be followed for a year after the last infusion.

"Currently, there is no approved therapy that can delay the degenerative process in Parkinson's disease," Schiess said. "By investigating a treatment that can slow or stop the progression, we hope to improve the quality of life of those suffering from the disease. The ultimate goal is to use this treatment in individuals with a prodromal condition, meaning they are showing early signs of Parkinson's disease but are not yet clinically symptomatic. We hope to be able to potentially stop the diease's conversion or clinical manifestation in patients who are high-risk."

The Phase II trial, approved by the U.S. Food and Drug Administration, is supported with funding from the Michael J. Fox Foundation, John S. Dunn Foundation, and John and Kyle Kirksey.

Other McGovern Medical School faculty co-authors on the paper included Jessika Suescun, MD, Christopher Adams, MD, and Sean Savitz, MD, in the Department of Neurology. Marie-Francoise Doursout, PhD, Department of Anesthesiology; Charles Green, PhD, Department of Pediatrics; and Jerome G. Saltarrelli, PhD, Department of Surgery. Timothy M. Ellmore, PhD, Department of Psychology at the City College of New York, N.Y., was senior author.

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QC Kinetix (Myrtle Beach) is the Stem Cell Therapy and Regenerative Medicine Clinic Myrtle Beach – Press Release – Digital Journal

Saturday, April 17th, 2021

Myrtle Beach, SC - QC Kinetix (Myrtle Beach) takes a different healthcare approach to most clinics in Myrtle Beach. It is a regenerative medicine clinic that focuses on non-surgical methods of managing pain. Regenerative medicine focuses on whole-body healing by using blood, cells, and tissues to help repair damaged areas and lessen inflammation and pain. Whether the pain is orthopedic or deep in the muscles and tendons, the clinics regenerative medicine technique is a non-invasive way to heal the body.

The physicians at QC Kinetix (Myrtle Beach) believe that whether a patient is suffering from persistent pain caused by an injury, disease, or age can permanently solve the problem. They do this by focusing on several different medical methods to help their patients regain their lives pain-free, to perform daily tasks without difficulty. The clinic treatments include the use of lasers, ultrasounds, regenerative cells, and platelet-rich plasma.

For the success of platelet-rich plasma injections or PRP therapy, the team mixes the patients platelets with plasma before injecting it into the injured area. Another area of regenerative therapy methods the clinic uses is called stem cell therapy. The stem cell therapy technique involves the team taking stem cells from a patients bone marrow and injecting them into inflamed or damaged areas. This injection of stem cells prompts the body to generate more red blood cells, reducing inflammation and pain.

QC Kinetix (Myrtle Beach) guarantees that all the patients who trust them will feel increased pain relief from one of their regenerative medicine treatments. The pain clinic ensures that they alleviate pain on several parts of the body, including the shoulder, elbow, wrist, ankle, low back, hip, knee, and feet.

To alleviate the pain from these areas, the clinic offers an array of services for Myrtle Beach residents. They include QC Knee that treats knee pain, cracking/popping, knee arthritis, and injuries such as torn ACL, MCL, LCL, and meniscus. QC Injury for patients of acute sports-related and musculoskeletal injuries and joint pain. QC 2M takes care of joint pain due to arthritis in the knees, shoulder, ankle, wrist, feet, hands, elbow, lower back, hips, and more.

Patients who visit the Myrtle Beach knee pain doctoralso enjoy QC Per4M, a treatment to improve energy, muscle strength, endurance, and appropriate weight loss with hormone replacement therapy. And QC Medical for patients with non-sports-related musculoskeletal pain resulting from sciatica, plantar fasciitis, or tendonitis.

The entire QC Kinetix staff (Myrtle Beach) believes that regenerative medicine, including stem cell therapy, works on several conditions. They include arthritis, plantar fasciitis, muscle damage, orthopedic pain, and tendon issues all over the body.

To learn more about QC Kinetix (Myrtle Beach) - Myrtle Beach, joint pain doctor, call (843) 310-2703 to schedule an appointment. Or visit their location, 8210 Devon Ct Suite A, Myrtle Beach, SC, 29572, US. For any inquiries about the services they offer, visit their website for more information.

Media ContactCompany Name: QC Kinetix (Myrtle Beach)Contact Person: Adam RoseEmail: Send EmailPhone: (843) 310-2703Address:8210 Devon Ct Suite A City: Myrtle BeachState: SCCountry: United StatesWebsite: https://qckinetix.com/myrtle-beach/

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Regenerative Medicine Market 2021 Value with Status and Global Analysis DePuy Synthes, Osiris Therapeutics, Medtronic, Stryker, Acelity, ZimmerBiomet…

Saturday, April 17th, 2021

The Regenerative Medicine Market report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. The report provides in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

Get Free Sample Copy of this Report:

https://www.marketinsightsreports.com/reports/10292408189/global-regenerative-medicine-market-growth-status-and-outlook-2020-2025/inquiry?Mode=A1

Top LeadingCompaniesof Global Regenerative Medicine Market areDePuy Synthes, Osiris Therapeutics, Medtronic, Stryker, Acelity, ZimmerBiomet, UniQure, MiMedx Group, Cellular Dynamics International, Organogenesis, Vericel Corporation, Mesoblast, Guanhao Biotech, Vcanbio, Cytori, Golden Meditech, Bellicum Pharmaceuticals, Celgene, Gamida Cell and others.

On The Basis Of Product, The Regenerative Medicine Market Is Primarily Split Into

Cell Therapy

Tissue Engineering

Biomaterial

Other

On The Basis Of End Users/Application, This Report Covers

Dermatology

Cardiovascular

CNS

Orthopedic

Others

Regional Outlook of Regenerative Medicine Market report includes the following geographic areas such as: North America, Europe, China, Japan, Southeast Asia, India and ROW.

Influence of the Regenerative Medicine market report:

-Comprehensive assessment of all opportunities and risk in the Regenerative Medicine market.

Regenerative Medicine market recent innovations and major events.

-Detailed study of business strategies for growth of the Regenerative Medicine market-leading players.

-Conclusive study about the growth plot of Infrared Imaging market for forthcoming years.

-In-depth understanding of Regenerative Medicine market-particular drivers, constraints and major micro markets.

-Favourable impression inside vital technological and market latest trends striking the Regenerative Medicine market.

Browse Full Report at:

https://www.marketinsightsreports.com/reports/10292408189/global-regenerative-medicine-market-growth-status-and-outlook-2020-2025?Mode=A1

What Are The Market Factors That Are Explained In The Report?

Key Strategic Developments:The study also includes the key strategic developments of the market, comprising R&D, new product launch, M&A, agreements, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a global and regional scale.

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Key Market Features:The report evaluated key market features, including revenue, price, capacity, capacity utilization rate, gross, production, production rate, consumption, import/export, supply/demand, cost, market share, CAGR, and gross margin. In addition, the study offers a comprehensive study of the key market dynamics and their latest trends, along with pertinent market segments and sub-segments.

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Regenerative Medicine Market 2021 Value with Status and Global Analysis DePuy Synthes, Osiris Therapeutics, Medtronic, Stryker, Acelity, ZimmerBiomet...

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The Vatican’s Pontifical Council for Culture and The Cura Foundation "Unite to Prevent" – PRNewswire

Saturday, April 17th, 2021

Rabbi Elie Abadie, M.D., senior rabbi, Jewish Council of the Emirates and Association of Gulf Jewish Communities.

Jonathan J. Bush, Jr., executive chair, Firefly Health.

Amy Abernethy, M.D., Ph.D., former principal deputy commissioner and acting chief information officer, U.S. Food and Drug Administration.

Deepak Chopra, M.D., founder, The Chopra Foundation and founder, Chopra Global.

Micah Aberson, executive vice president, Sanford Health.

George Church, Ph.D., founding core faculty and lead, Wyss Institute, Harvard University; professor of genetics, Harvard Medical School; professor of health sciences and technology, Harvard and Massachusetts Institute of Technology.

Gina Agiostratidou, Ph.D., program director, Type 1 diabetes program, The Leona M. and Harry B. Helmsley Charitable Trust.

Ellen Wright Clayton, M.D., J.D., Craig-Weaver Professor of pediatrics and professor of health policy, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center and professor of law, Vanderbilt School of Law.

Rick Anderson, president and general manager, North America, DarioHealth.

Chelsea Clinton, D.Phil., M.P.H., vice chair, Clinton Foundation.

Stphane Bancel, CEO, Moderna.

Kelly L. Close, co-founder and chair of the board, The diaTribe Foundation.

Justin L. Barrett, Ph.D., president, Blueprint 1543, honorary professor of theology and the sciences, St. Andrews University, School of Divinity.

Francis S. Collins, M.D., Ph.D., director, U.S. National Institutes of Health.

Nir Barzilai, M.D., The Rennert Chair of Aging Research, professor of medicine and genetics and director, Nathan Shock Center of Excellence in the Biology of Aging, Albert Einstein College of Medicine.

Cindy Crawford, model and entrepreneur.

Marc Benioff, chair and CEO, Salesforce.

John F. Crowley, chair of the board and CEO, Amicus Therapeutics, Inc.

Paul Bloom, Ph.D., Brooks and Suzanne Ragen Professor of Psychology, Yale University.

Ray Dalio, founder, co-chair and co-chief information officer, Bridgewater Associates, New York Times best-selling author of "Principles: Life & Work."

Emma Bloomberg, founder and CEO, Murmuration.

Richard J. Davidson, Ph.D., professor of psychology and psychiatry, and founder and director of the Center for Healthy Minds, University of Wisconsin-Madison.

Albert Bourla, D.V.M., Ph.D., chair and CEO, Pfizer.

Grand Hospitaller, H.E. Dominique Prince de La Rochefoucauld-Montbel, Bailiff Grand Cross of Honour and Devotion in Obedience, The Sovereign Order of Malta.

Otis W. Brawley, M.D., Bloomberg Distinguished Professor of oncology and epidemiology, Johns Hopkins University.

Marilyn Glassberg, M.D., division chief of pulmonary medicine, critical care and sleep medicine; senior director of clinical research for strategy and growth, department of internal medicine, University of Arizona College of Medicine.

Dan Buettner, founder, Blue Zones.

Laurie H. Glimcher, M.D., president and CEO, Dana-Farber Cancer Institute, Richard and Susan Smith professor of medicine, Harvard Medical School, director, Dana-Farber/Harvard Cancer Center.

Ronald A. DePinho, M.D., Distinguished University Professor and past president, MD Anderson Cancer Center.

Dr. Jane Goodall, DBE, founder, the Jane Goodall Institute and U.N. Messenger of Peace.

Joseph M. DeVivo, president, hospital and health systems, Teladoc Health.

Scott Gottlieb, M.D., resident fellow, American Enterprise Institute and 23rd commissioner, U.S. Food and Drug Administration.

Spencer P. Eccles, co-founder and managing partner, The Cynosure Group.

Andre Goy, M.D., physician-in-chief of Oncology Services, Hackensack Meridian Health;chair, John Theurer Cancer Center; founding chair of Oncology, Hackensack Meridian School of Medicine.

Rev. Terrence P. Ehrman, C.S.C., Ph.D., visiting assistant teaching professor, department of theology, University of Notre Dame.

Kurt J. Griffin, M.D., Ph.D., Todd and Linda Broin Chair for Diabetes Research; director of clinical trials, The Sanford Project, Sanford Research; and associate professor, pediatric endocrinology, Sanford School of Medicine, University of South Dakota.

Michael E. Farkouh, M.D., Peter Munk Chair in Multinational Clinical Trials; director, Heart & Stroke/Richard Lewar Centre of Excellence; vice-chair, research and professor of medicine, department of medicine, University of Toronto.

Sanjay Gupta, M.D., award-winning chief medical correspondent, CNN and neurosurgeon.

Paul Farmer, M.D., Ph.D., Kolokotrones University professor and chair, department of global health and social medicine, Harvard Medical School; co-founder and chief strategist, Partners In Health.

Robert J. Hariri, M.D., Ph.D., founder, chair, and CEO, Celularity.

Anthony S. Fauci, M.D., director, National Institute of Allergy and Infectious Diseases, U.S. National Institutes of Health.

Katherine High, M.D., president, therapeutics, AskBio.

Judy Faulkner, founder and CEO, Epic.

Marc Hodosh, founder and co-host, "LIFE ITSELF."

David Feinberg, M.D., vice president, head of Google Health, Google.

Donald Hoffman, Ph.D., professor emeritus of cognitive sciences, University of California, Irvine.

Rev. Kevin T. FitzGerald, S.J., Ph.D., John A. Creighton University Professor and chair, department of medical humanities, Creighton University.

Jacquelyn Kulinski, M.D., director of the preventive cardiology program and associate professor of medicine, Medical College of Wisconsin.

Rene Fleming, soprano; arts and health advocate; artistic advisor, John F. Kennedy Center for the Performing Arts.

Samarth Kulkarni, Ph.D., CEO, CRISPR Therapeutics.

Robert C. Garrett, CEO, Hackensack Meridian Health.

Timothy A. Lash, president, West Health Policy Center.

Rebekah E. Gee, M.D., CEO, Louisiana State University Health Care Services; former secretary, Louisiana Department of Health.

William W. Li, M.D., president, medical director and CEO, The Angiogenesis Foundation.

Debra Houry, M.D., M.P.H., director, National Center for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention.

Peter Libby, M.D., cardiovascular specialist, Brigham and Women's Hospital and Mallinckrodt Professor of medicine, Harvard Medical School.

Ryan Howard, founder and CEO, 100Plus.

Dan Liljenquist, senior vice president and chief strategy officer, Intermountain Healthcare.

Mark Hyman, M.D., head of strategy and innovation, Cleveland Clinic Center for Functional Medicine.

Shelley Lyford, president and CEO, Gary and Mary West Foundation.

Elder William K. Jackson, M.D., General Authority Seventy, The Church of Jesus Christ of Latter-day Saints.

Peter Marks, M.D., Ph.D., director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration.

Jo Ann Jenkins, CEO, AARP.

Brandon Marshall, NFL athlete, co-founder, Project 375 and founder, House of Athlete.

Henry Ji, Ph.D., chair, president and CEO, Sorrento Therapeutics.

Mark McClellan, M.D., Ph.D., director, Duke-Robert J. Margolis, M.D., Center for Health Policy, and the Robert J. Margolis, M.D., Professor of Business, Medicine, and Policy, Duke University.

Thupten Jinpa, Ph.D., president, Compassion Institute.

Gary Mendell, founder and CEO, Shatterproof.

Carl June, M.D., the Richard W. Vague Professor in Immunotherapy and director of the Center for Cellular Immunotherapies, Perelman School of Medicine; director of the Parker Institute for Cancer Immunotherapy, University of Pennsylvania.

Jamie Metzl, J.D., Ph.D., founder and chair, OneShared.World.

Cigall Kadoch, Ph.D., professor, Dana-Farber Cancer Institute and Harvard Medical School; founder, Foghorn Therapeutics.

Matthew Might, Ph.D., professor and director, Hugh Kaul Precision Medicine Institute, University of Alabama at Birmingham.

Dean Kamen, president, DEKA R&D, chair ARMI, and founder, FIRST.

Rosalind Picard, Sc.D., professor, MIT Media Lab; chief scientist and chair, Empatica.

Allen J. Karp, executive vice president, healthcare management and transformation, Horizon Blue Cross Blue Shield of New Jersey.

Renato Poletti, president, Science and Faith (STOQ) Foundation and president, Foundation for Heritage and Cultural and Artistic Activities of the Church.

Kerry Kennedy, president, Robert F. Kennedy Human Rights.

Cardinal Gianfranco Ravasi, president, Pontifical Council for Culture.

Stephen K. Klasko, M.D., president, Thomas Jefferson University, CEO, Jefferson Health.

Elder Dale G. Renlund, M.D., Quorum of the Twelve Apostles, The Church of Jesus Christ of Latter-day Saints.

Aaron J. Kowalski, Ph.D., president and CEO, JDRF International.

David C. Rhew, M.D., chief medical officer and vice president of healthcare, Worldwide Commercial Business, Microsoft.

Maria Millan, M.D., president and CEO, California Institute for Regenerative Medicine.

Walter Ricciardi, M.D., full professor in hygiene, Universit Cattolica del Sacro Cuore, Rome; president, Mission Board for Cancer of the European Commission; president, World Federation of Public Health Associations.

Princess Dina Mired, immediate past president, Union for International Cancer Control; patron of SIOP; honorary president of EORTC; special envoy for NCD's Vital Strategies; member of WHO Expert Group for the Elimination of Cervical Cancer.

Sheri L. Robb, Ph.D., professor, Indiana University School of Nursing.

William C. Mobley, M.D., Ph.D., associate dean for neurosciences initiatives, and interim director of the Sanford Institute for Empathy and Compassion, department of neurosciences, University of California San Diego.

Robert S. Rosenson, M.D., Director of Metabolism and Lipids, professor of medicine and cardiology, Icahn School of Medicine at Mount Sinai.

Dariush Mozaffarian, M.D., Dr.P.H., dean, Friedman School of Nutrition Science and Policy, Tufts University.

Frank J. Sasinowski, J.D., M.P.H., director, Hyman, Phelps & McNamara.

Michael Murray, Ph.D., president, Arthur Vining Davis Foundations.

Roy Schoenberg, M.D., M.P.H., president and co-CEO, Amwell.

Julien Musolino, Ph.D., associate professor, department of psychology, Rutgers University.

John Sculley, managing partner, Sculley Advisors.

David B. Nash, M.D., founding dean emeritus and the Raymond C. and Doris N. Grandon Professor of Health Policy, Jefferson College of Population Health.

Stephen Shaya, M.D., managing director, Akkad Holdings; executive servant leader, J&B Medical.

Timothy O'Connor, Ph.D., Mahlon Powell Professor of Philosophy, Indiana University.

Jerrell W. Shelton, chair, president and CEO, Cryoport.

Emmanuel "Manny" Ohonme, president and CEO, Samaritan's Feet International.

Andrew C. von Eschenbach, M.D., president, Samaritan Health Initiatives; former Commissioner U.S. Food and Drug Administration and 12th Director, National Cancer Institute.

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The Vatican's Pontifical Council for Culture and The Cura Foundation "Unite to Prevent" - PRNewswire

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Breakthrough in purification of fossil pollen for dating of sediments by a new large-particle on-chip sorter – Science Advances

Saturday, April 17th, 2021

Particle sorting is a fundamental method in various fields of medical and biological research. However, existing sorting applications are not capable for high-throughput sorting of large-size (>100 micrometers) particles. Here, we present a novel on-chip sorting method using traveling vortices generated by on-demand microjet flows, which locally exceed laminar flow condition, allowing for high-throughput sorting (5 kilohertz) with a record-wide sorting area of 520 micrometers. Using an activation system based on fluorescence detection, the method successfully sorted 160-micrometer microbeads and purified fossil pollen (maximum dimension around 170 micrometers) from lake sediments. Radiocarbon dates of sorting-derived fossil pollen concentrates proved accurate, demonstrating the methods ability to enhance building chronologies for paleoenvironmental records from sedimentary archives. The method is capable to cover urgent needs for high-throughput large-particle sorting in genomics, metabolomics, and regenerative medicine and opens up new opportunities for the use of pollen and other microfossils in geochronology, paleoecology, and paleoclimatology.

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Breakthrough in purification of fossil pollen for dating of sediments by a new large-particle on-chip sorter - Science Advances

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2021 Growth Opportunities in Gene Therapies, Cancer, Disease Treatment & Monitoring, Surgical Applications and Cosmetics – ResearchAndMarkets.com…

Saturday, April 17th, 2021

DUBLIN--(BUSINESS WIRE)--The "Growth Opportunities in Gene Therapies, Cancer, Disease Treatment & Monitoring, Surgical Applications and Cosmetics" report has been added to ResearchAndMarkets.com's offering.

This edition of the Life Science, Health & Wellness Technology Opportunity Engine (TOE) consists of insights across gene therapies, cancer, neurological, allergic and respiratory diseases treatment and monitoring. Further, novel drugs, drug delivery systems, surgical support applications, artificial intelligence-based imaging, as well as telehealth systems are discussed. Some innovations cover the upcoming innovations in cosmetics, acne treatment, food packing, and natural extract processing technologies

The Life Science, Health & Wellness TOE will feature disruptive technology advances in the global life sciences industry. The technologies and innovations profiled will encompass developments across genetic engineering, drug discovery and development, biomarkers, tissue engineering, synthetic biology, microbiome, disease management, as well as health and wellness among several other platforms.

The Health & Wellness cluster tracks developments in a myriad of areas including genetic engineering, regenerative medicine, drug discovery and development, nanomedicine, nutrition, cosmetic procedures, pain and disease management and therapies, drug delivery, personalized medicine, and smart healthcare.

Innovations in Life Sciences, Health & Wellness

For more information about this report visit https://www.researchandmarkets.com/r/2d6ood

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2021 Growth Opportunities in Gene Therapies, Cancer, Disease Treatment & Monitoring, Surgical Applications and Cosmetics - ResearchAndMarkets.com...

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Infusion Improves Immune Response of Aging Frailty Following Flu Shot – PrecisionVaccinations

Saturday, April 17th, 2021

(Precision Vaccinations)

Florida-based Longeveron Inc. announced the completion of the Companys Phase I/II clinical study of the use of Lomecel-B to improve immune response to influenza vaccine in subjects with Aging Frailty.

Longeveron stated in a press release issued on April 15, 2021, 'it is anticipated that the top-line trial results will be announced in the 3rdquarter of 2021.'

Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cellproduct manufactured under current good manufacturing practicesby Longeveron.

The company says 'Lomecel-B has the potential to reduce inflammation associated with Aging Frailty and to promote an anti-inflammatory state by releasing anti-inflammatory molecules, which can balance the immune system and improve the function of B lymphocytes.

As B cells are responsible for antibody production in response to vaccines, Lomecel-B may boost antibody generation and immunity following vaccination in subjects with Aging Frailty.'

Completion of this clinical study to investigate Lomecel-B as a new therapeutic approach to boost immune response serves as an important initial step to meet the critical unmet medical need for those with Aging Frailty, who often respond poorly to vaccines, said Sean Leng, MD, Ph.D., Professor of Medicine, Molecular Microbiology and Immunology at Johns Hopkins University School of Medicine and Bloomberg School of Public Health and the studys principal investigator.

Aging Frailty is a life-threatening geriatric condition affecting approximately 15% of Americans over 65 or 8.1 million individuals. Aging Frailty patients are vulnerable to poor clinical outcomes compared to their age-matched peers despite sharing similar comorbidities and demographics. Therefore it is considered by some as an extreme form of unsuccessful aging.

Geoff Green, CEO of Longeveron. From the inception of Longeveron, we have focused our efforts on using a regenerative medicine approach to treat chronic, aging-related diseases and conditions, such as frailty and Alzheimers disease, with the goal of improving healthspan.

Miami-basedLongeveron is a clinical-stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions.

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Infusion Improves Immune Response of Aging Frailty Following Flu Shot - PrecisionVaccinations

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Senti Biosciences in $645M Spark pact to drive gene circuits into the fast lane – FierceBiotech

Saturday, April 17th, 2021

Roches gene therapy unit Spark Therapeutics has penned a $645 million-plus biobucks pact with Bayer-backed Senti Biosciences for new tech aimed at tweaking next-gen gene therapies.

Under the deal, Spark will maneuver Senti Bios gene circuit tech to drive the development of gene therapy 2.0. specifically directed toward specific cell types in the central nervous system, eye or liver.

Fierce 15 winner Senti Bios approach involves what it calls gene circuits, essentially tweaking a cells genetic code which can morph in order to address the severity of a disease, all the while limiting side effects.

Internally, the Californian biotech is applying its gene circuit tech specifically toward allogeneic chimeric antigen receptor natural killer cells, a growing area of interest in oncology.

Senti Bios lead assets out of this platform include SENTI-202 for acute myeloid leukemia, SENTI-301 for hepatocellular carcinoma and others for undisclosed solid tumor targets.

And its not just cancer: Senti Bio believes its on to something big, and it says it can also target a whole host of other areas and gene therapy delivery modalities such as immunology, neuroscience, cardiovascular disease, regenerative medicine and genetic diseases.

At the start of the year, it got off a major $105 million series B funding round, building on the initial $53 million it got off three years back. It also has the backing of some big names, with Leaps by Bayer and Amgens VC arm as well as Matrix Partners China, Mirae Asset Capital, Ridgeback Capital, Intel Capital, New Enterprise Associates, 8VC and Lux Capital all pitching in for its latest cash haul.

RELATED: Spark Therapeutics nabs CMO from new owner Roche

Now, it has a major pact with Spark/Roche that will see the biotech nab an undisclosed upfront payment and a mixture of biobucks, all of which could see Senti Bio bring home $645 million-plus.

For its part, Senti will be responsible for designing, building and testing cell type- and disease specific-synthetic promoters for use in certain CNS-, ocular- or liver-directed gene therapies.

Spark, meanwhile, holds an option to exclusively license a defined number of synthetic promoters emerging from the collab for use in developing gene therapy products in specified indications.

Should it hit go on that option, Spark will be responsible for conducting preclinical, clinical and sales work for any gene therapies that use Senti Bios licensed synthetic promoters.

We view gene circuits as a critical component of any advanced cell and gene therapy, regardless of therapeutic area or delivery modality, said Tim Lu, M.D., Ph.D., CEO of Senti Bio.

This collaboration with Spark Therapeutics aligns with our goal of enabling truly dynamic therapies that have the ability to discriminate between certain cell types, selectively express various payloads, and respond to diverse disease environments.

We are extremely impressed by the capabilities and know-how of Spark Therapeutics specifically in the area of gene therapy, and we look forward to bringing our mutual expertise together under this collaboration to harness the power of gene circuits to develop gene therapies that are clinically meaningful to patients.

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Senti Biosciences in $645M Spark pact to drive gene circuits into the fast lane - FierceBiotech

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Regenerative medicine is already changing the way drugs are discovered and tested – MedCity News

Sunday, April 4th, 2021

Anthony Atala receives an award for his innovations in 3D printing to create human organs at the Smithsonian Magazines 2016 American Ingenuity Awards after at National Portrait Gallery on December 8, 2016 in Washington, DC. Photo credit: Leah Puttkammer, Getty Images

Regenerating a solid organ for transplant might be years away from reaching patients. But regenerative medicine technology as a tool for discovering and testing new drugs? Thats already happening.

In Winston-Salem, North Carolina, scientists are 3D printing miniature organs that replicate the anatomy and function of a heart, liver, lungs, even the brain, said Anthony Atala, a professor of urology at Wake Forest University. Their lifetimes last just months, but thats more than enough time to assess a drug in ways that lab tests or even animal tests cannot.

After tens of millions of dollars of investment, by the time a drug gets into a Phase 1 clinical trial through the FDA, 90% of those drugs end up failing, Atala said, speaking on March 24 during the Oracle Health Sciences Connect 2021 conference. Its due to the testing that is not really accurate. Therefore, the strategy is to create these miniature organs.

Atala is the director of the Wake Forest Institute for Regenerative Medicine (WFIRM), which is conducting research on about 40 different tissues and organs. So far, the institute has launched 15 technologies that use human cells to engineer tissues and organs.

The drug testing happens on organoids, an invitro system that stands in for an organ. These miniature organs can be made in both healthy and diseased states, Atala said. These chips can create the human equivalent of physiological responses. For example, scientists can prompt a heart attack or a stroke to assess what a drug would do to an organ affected by those conditions.

WFIRMs drug discovery research represents a convergence of technologies. This body-on-a-chip technology is used to screen libraries of compounds for both safety and efficacy ahead of animal studies and clinical trials, Atala said. Data are cataloged at every step of the process. Artificial intelligence can then be applied to find patterns in the data, improving predictive modeling for drug development.

The Wake Forest research is being conducted as part of the Humanoid Sensor Consortium, a partnership comprised of pharmaceutical companies, academic institutions, and government agencies. The WFIRMs own drug discovery collaborators include the Biomedical Advanced Research and Development Authority (BARDA), which has provided $25 million for research into potential countermeasures to chemical agents. The Defense Threat Reduction Agency (DTRA) has provided more than $26 million in funding for the development of countermeasures for nerve agents.

The technologies that are closest to helping patients are part of a new approach to personalized medicine. The miniature organs are used to help oncologists make treatment decisions. A patients own tissue is used create tumors on a chip, which is then used to test different chemotherapies. These chips are currently being evaluated in clinical trials.

Instead of trying out a treatment for six months and finding out it doesnt work, and then trying another regimen, by then the tumor might be too far gone, Atala said. We can now try to define what the best treatment is before the patient receives the first dose.

Regenerated organs are on the way, Atala said. Engineered skin products are entering the market. The next regenerative tissue products will be a bit more complex, taking on tubular structures. WFIRM has regenerated urethras by taking a small tissue sample from a patient and expanding those cells in a lab. Those cells populate a bioresorbable scaffold, which can then be implanted in the patient.

Solid organs pose the biggest challenge for regenerative medicine. These organs are comprised of many more cells that must be nourished by blood supply. WFIRMs research includes kidneys. A small tissue sample from a patient is expanded in a lab, yielding kidney units capable of producing urine. These kidney units can then be implanted in the patient. Atala said that this research is advancing to Phase 3 testing for patients in end-stage renal failure.

When WFIRM started in 2004, the scientists did not begin the research with an eye on which patients could be helped most by regenerative medicine technology, Atala said. But now, it seems the greatest area of need appears to be kidney transplant patients.

As you know, 80% of patients on the transplant wait list are actually waiting for a kidney, Atala said. So, if we can make a dent in that population, that would be a great thing.

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Regenerative medicine is already changing the way drugs are discovered and tested - MedCity News

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Aspect Biosystems and JSR Corporation Enter Collaboration to Develop Bioprinted Vascularized Tissues for Regenerative Medicine – BioSpace

Sunday, April 4th, 2021

VANCOUVER, British Columbia--(BUSINESS WIRE)-- Aspect Biosystems, a privately held biotechnology company pioneering the development of bioprinted therapeutics, is pleased to announce a new joint development program with JSR Corporation, a global leader in advanced materials innovation. This collaboration builds on the existing partnership between the two companies and will see the combining of Aspects proprietary microfluidic 3D bioprinting platform with JSRs advanced materials technology to develop implantable vascularized tissues for kidney regeneration and other applications in regenerative medicine.

The vascularized implantable tissues we develop through this collaboration will enable the next generation of regenerative medicine solutions by supporting longer-term function of therapeutic cells in the body, said Tamer Mohamed, President and CEO of Aspect Biosystems. We are excited to work with JSRs innovative team based in Japan, a country at the forefront of regenerative medicine, and we look forward to continue making breakthroughs with our broadly applicable technology platform.

In our work through JSR Life Sciences, we are seeing the need for advanced, innovative materials continue to grow throughout the biosciences, said Toru Kimura, CTO of JSR Corporation. This joint development program with Aspect Biosystems is testament to that and an important step in enabling and accelerating highly impactful areas in regenerative medicine.

About Aspect Biosystems

Aspect Biosystems is a biotechnology company creating bioprinted therapeutics as medicines of the future. Aspect is applying its microfluidic 3D bioprinting technology internally to develop these advanced cell therapies and partnering with leading researchers and industry innovators worldwide to tackle the biggest challenges in regenerative medicine. Learn more at http://www.aspectbiosystems.com.

About JSR Corporation

JSR Corporation is a multinational company with research-oriented organization that pursues close collaborations with leading innovators in a number of industries that are a key to the present and future welfare of human society: life sciences, synthetic rubbers, electronic materials, display and optical materials. JSR Corporation conducts its global life sciences business through JSR Life Sciences LLC. JSR Life Sciences provides specialized materials, products and services to the biopharma and life sciences industries both directly and through its subsidiaries MEDICAL & BIOLOGICAL LABORATORIES CO., LTD, KBI Biopharma, Inc., Selexis SA, and Crown Biosciences. Learn more at http://www.jsr.co.jp/jsr_e/ and https://www.jsrlifesciences.com/

View source version on businesswire.com: https://www.businesswire.com/news/home/20210330005431/en/

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Aspect Biosystems and JSR Corporation Enter Collaboration to Develop Bioprinted Vascularized Tissues for Regenerative Medicine - BioSpace

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The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy – JD Supra

Sunday, April 4th, 2021

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell therapy, and the increasing government spend related to these novel techniques, have now caught the eye of federal regulators and prosecutors. In this client alert, we profile some brief context of stem cell therapy, the governments regulations governing these techniques, and some of the best practices for those interested in this emerging space.

Stem cells are cells from which all other cells with specialized functions are generated (i.e., the bodys raw materials). Stem cells may duplicate themselves to create more stem cells or they may generate cells with a specific function like blood or brain cells.

Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions and diseases from multiple sclerosis to vision loss to traumatic spinal cord injuries to Lou Gehrigs disease just to name a few.

The Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. While the FDA has acknowledged that stem cell therapy has the potential to treat diseases or conditions for which few treatments exist, there are still only a few treatments that have actually been approved by the FDA. Many treatments are still only in early investigatory stages.

The FDA has recognized the massive potential that stem cell therapy has in allowing patients treatments for various conditions. Consequently, in 2017, the FDA issued guidance indicating its intent to exercise enforcement discretion as a means to support and expedite the development of regenerative medicine products. This enforcement discretion period was to allow innovators time to determine whether to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application as appropriate. The FDA, however, has made clear its enforcement discretion policy only applies to products that do not raise potential significant safety concerns. What the FDA considers significant is debatable, creating uncertainty and ambiguity for those who might be relying on the FDAs enforcement discretion period.

Initially, the FDA stated that its enforcement discretion period would last through November 2020. But in July 2020, the FDA extended its enforcement discretion period through May 2021 a fast-arriving date. It remains unclear whether the FDA intends to extend the time period of its enforcement discretion any further, but either way, stem cell therapy providers would be well-served by planning for and expecting enforcement efforts to ramp up in the near future.

In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy hype, and encouraged consumers to make sure any stem cell therapy treatments were either approved or being studied as an IND. The FDAs concerns have led to multiple enforcement actions, including one just last month. On February 1, 2021, for example, the government announced the indictment of Ashton Derges, a healthcare provider in Missouri, who marketed stem cell shots as a successful treatment for various conditions, including COVID-19. According to the indictment, Derges was paid nearly $200,000 by patients for the stem cell shots, none of which actually contained stem cells at all. While this alleged fraud was not particularly sophisticated, it nonetheless marked a significant development: the governments first criminal prosecution of those touting stem cell therapies.

But blatant fraud is not the only type of stem cell therapy case the government has expressed interest in investigating. A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. A good case study of the risks associated with aggressive marketing of stem cell therapy is a case out of Florida involving US Stem Cell Clinic Inc. The clinic was marketing stem cell therapy to treat conditions and diseases such as Parkinsons disease, stroke, and brain injuries none of which were approved by the FDA. And, much of the marketing that US Stem Cell Clinic used promised almost miraculous results. As a result, last year, the FDA successfully permanently enjoined the US Stem Cell Clinic from selling or providing those stem cell therapy treatments. Notably, this case was pursued by the FDA despite the FDA explicitly stating its intent to be lenient with emerging stem cell therapy treatments.

Stem cell therapy is a groundbreaking medical tool with great possibilities to treat a plethora of diseases and conditions. As the industry continues to expand, so will the governments interest. Our firm continues to see an uptick in cases involving stem cell therapy treatments. And we have successfully assisted clients in avoiding unnecessary scrutiny by the FDA and other government regulators.

If you are in the stem cell therapy industry or are considering offering stem cell therapy treatments, we recommend that you:

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The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra

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Russell Health Highlighted in the Silicon Review’s ’50 Leading Companies of the Year 2021′ – PRNewswire

Sunday, April 4th, 2021

WILLOWBROOK, Ill., March 31, 2021 /PRNewswire/ --Based in Willowbrook, Illinois, Russell Health, a national marketer and distributor of specialty medical products and services,was recently announced as one of The Silicon Review's "50 Leading Companies of the Year 2021."The feature strategically places the Russell Health brand alongside other tech innovators in industries including marketing, finance, software, sustainability, leadership and health. Russell Health's Profile features a Q&A with the leading tech publication covering the history of the Russell Health brand, services offered, anticipated trends in Stem Cell Recruitment Therapy, continued product category research, and more. Read the full feature here.

About Russell Health: Russell Health and its partners have distributed regenerative therapy products nationwide and achieved profound clinical outcomes in multiple therapeutic areas including cosmetics, wound care, pain management, podiatry, orthopedic, optometry and gynecology.

With their partners and suppliers, they work to provide innovative life-changing and sustaining products and therapies to patients and healthcare providers around the world.

Stem Cell Recruitment Therapy products take advantage of the body's ability to repair itself. Responsibly sourced acellular tissue allografts are helping people of all ages to recover from injuries and get their life back.

Quote about the current landscape and anticipated trends in Stem Cell Recruitment Therapy:

"We do not distribute 'Stem Cells' or 'Stem Cell Procedures'. All our products are acellular and do not contain live stem cells. By using a combination of growth factors and other endogenously synthesized molecules, Stem Cell Recruitment Therapyproducts help to assist the body with repair, reconstruction and supplementation of the recipient's tissue, as mentioned above. During the pandemic, we have seen a lot of patients and physicians searching for alternative treatments like ours that are safe and effective without posing any additional risks of infection while providing the clinic."(Ryan Salvino, CEO of Russell Health)

Quote about Russell Health's involvement in Stem Cell Recruitment Therapy research:

"We are currently working with some of the top leaders in the regenerative medicine field to continue to grow and provide new innovative products to our customers and their patients. We are always looking for new breakthrough products in the market to stay abreast on the new technologies and innovations in the field. We are consistently documenting patient results to provide clinicians with testimonialson how effective the Stem Cell Recruitment Therapy products are and how they are positively affecting patients' lives." (Jonathan Benstent, Vice President of Russell Health)

Visit Russell Health online to learn more about Stem Cell Recruitment Therapy. For media inquiries or to contact the Russell Health team directly, please visit http://www.russellhealth.comor email [emailprotected].

Contact: Veronica BennettPhone: 844-249-6200Email: [emailprotected]Mailing Address: 621 Plainfield Rd., Willowbrook, IL 60527Online: http://www.russellhealth.comSocial Media: http://www.linkedin.com/company/russell-health/

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Russell Health Highlighted in the Silicon Review's '50 Leading Companies of the Year 2021' - PRNewswire

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Global Automated and Closed Cell Therapy Processing Systems Market Trends and Forecasts, 2020-2030: Cell Processing Steps, Scale of Operations, End…

Sunday, April 4th, 2021

Dublin, April 01, 2021 (GLOBE NEWSWIRE) -- The "Automated and Closed Cell Therapy Processing Systems Market By Cell Processing Steps, Scale of Operations, End Users and Geographical Regions: Industry Trends and Global Forecasts, 2020 - 2030" report has been added to ResearchAndMarkets.com's offering.

The "Automated and Closed Cell Therapy Processing Systems Market: Focus on Apheresis, Expansion, Harvest, Fill/Finish, Cryopreservation, Thawing, 2020-2030" report features an extensive study of the current market landscape and future opportunities associated with the automated and closed cell therapy processing systems. The study also features a detailed analysis of key drivers and trends related to this evolving domain.

One of the key objectives of the report was to estimate the existing market size and the future growth potential of the automated and closed cell therapy processing systems. Based on various parameters, such as number of cell therapies under development, expected pricing, likely adoption rates, and potential cost saving opportunities from different automated and closed cell processing systems, we have developed informed estimates of the evolution of the market, over the period 2020-2030.

Advanced therapy medicinal products (ATMPs), such as cell therapies and gene therapies, have revolutionized the healthcare sector. Over the past two decades, more than 30 ATMPs have been approved. Moreover, according to a recent report (published by The Alliance for Regenerative Medicine), over 1,050 clinical trials are currently being conducted by over 1,000 companies, worldwide, focused on the evaluation of cell and gene therapies.

However, despite the numerous advances in this field, there are certain challenges that need to be addressed in order to achieve commercial success. For instance, the current cell therapy manufacturing process is labor-intensive, time consuming and costly. Further, the production of most of these specialized therapeutic products requires manual labor and are typically carried out discretely (open processing), thereby, rendering the processes difficult to scale-up, with high risk of contamination.

Another concern faced by cell and gene therapy manufacturers is batch-to-batch variability, given that even a minor change in the production protocol can affect the quality of the resulting product. Consequently, cell therapies are exorbitantly priced, ranging from USD 300,000 to USD 500,000 per dose.

Experts believe that some of the existing challenges related to cell therapy manufacturing can be addressed through the adoption of automated and closed cell processing systems. These solutions have been demonstrated to be capable of enabling stakeholders to manage various aspects of the cell therapy manufacturing process efficiently, while complying to global regulatory standards. Other benefits of such systems include reduced risk of contamination, optimum utilization of facility and resources, limited in-process variation and consistent product quality.

Further, the use of such automated systems enable significant reductions (in the range of 40% to 90%) in labor costs. In recent years, the cost saving potential of these systems, coupled to their ability to streamline and simplify the complex cell therapy processing (from initial cell collection till final formulation), has effectively captured the interest of several stakeholders engaged in this domain. Given the growing demand for cost-effective, personalized medicine, coupled to the benefits of automated and closed systems, we believe that this niche market is poised to witness significant growth in the foreseen future.

Scope of the Report

An insightful product competitiveness analysis, taking into consideration various relevant parameters, such as supplier power (based on the experience/expertise of the developer in this industry) and portfolio-related parameters, such as number of systems offered, cells supported, type of culture supported, scale of operation, applications, end users, support services offered, regulatory certifications/accreditations obtained and key product specifications.

Elaborate profiles of industry players that are currently offering automated and closed cell therapy processing systems, featuring an overview of the company, its financial information (if available), and a detailed description of the system(s) they offer. Each profile also includes a list of recent developments, highlighting the key achievements, partnership activity, and the likely strategies that may be adopted by these players to fuel growth, in the foreseen future.

An analysis of the various partnerships pertaining to automated and closed cell therapy processing systems, which have been established since 2016, based on several parameters, such as year of partnership, type of partnership model adopted, type of therapy, type of cell processing step, key automated and closed cell processing systems, partner's focus area, most active players (in terms of number of partnerships signed), and geographical location of collaborators.

A detailed assessment of the current market landscape, featuring an elaborate list of over 60 automated and closed systems, along with information on the cell therapy processing step for which they are designed (apheresis, separation, expansion, harvest, fill/finish, cryopreservation and thawing), their key features (traceability, user-friendliness, configurability and scalability, process monitoring, touch-screen user interface, data management, integration with other systems and alert system), product specifications (length, width, depth, height and weight), type of cells supported (stem cells and immune cells), type of cell culture (adherent and suspension), scale of operation (pre-clinical, clinical and commercial), application (research and therapeutic), end users (hospitals/medical centers/clinics, research institutes/academic institutes, laboratories, commercial organizations), key support services offered (product support, technical support, training, installation, qualification/validation, maintenance, regulatory support and others) and regulatory certification/accreditations obtained (GMP/cGMP, GAMP, GCP, GTP/cGTP, IEC standards, ISO standards, 21 CFR Part 11 and other).

The report features detailed transcripts of interviews held with the following industry stakeholders:

Key Questions Answered

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/ly01kj

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Global Automated and Closed Cell Therapy Processing Systems Market Trends and Forecasts, 2020-2030: Cell Processing Steps, Scale of Operations, End...

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Vitro Biopharma Retains Leading Health Care Executive as Acting Director of Regulatory Affairs & Director – Benzinga

Sunday, April 4th, 2021

GOLDEN, CO / ACCESSWIRE / April 3, 2021 / Vitro Biopharma, Inc. (formerly Vitro Diagnostics, Inc.) announced the appointment of Dr. Caroline Mosessian, PhD, DRSc, FACMPE, ACHE as its acting Director of Regulatory Affairs. Dr. Mosessian has an extensive background in regulatory science including a PhD, MS and Masters in Healthcare Administration degrees from USC in LA. In 2016 she was honored with the prestigious Top Ranked US Executive Award awarded to the top 1% of the millions of active executives in the United States. She is a trusted advisor for strategic development and operations to a variety of technology firms promoting innovation excellence to enhance quality of life for patients, caregivers and providers while optimizing outcomes and overall corporate success. In addition to regulatory expertise, she has extensive experience in the development, management and licensing of intellectual property, government and private fund raising, strategic planning and clinical research operations. She is fluent in several languages that support her international business development skills. She is also actively involved in local, national and international charitable organizations that emphasize humanitarian aid.

She has led numerous clinical studies of medical devices and pharmaceuticals through regulatory agency approval including the FDA and EMA leading to successful development of multi-million dollar clinical programs. She presently assists Vitro Biopharma in the guidance, drafting and submission of its pending IND phase I application to the FDA (Randomized, Double-blinded, placebo-controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells in adults with COVID-19). As a result, the FDA has authorized several expanded access/compassionate use INDs that employ IV infusion of AlloRx Stem Cells in the treatment of COVID-19 patients.

These results together with several additional clinical studies using MSCs are now providing substantial clinical evidence of safety and efficacy of stem cell therapy for COVID-19. Furthermore, since MSC therapy is independent of the genome of the virus, this MSC therapy is likely to be effective in treatment of COVID-19 patients infected with new variants resulting from viral mutation.

Dr. Jack Zamora, MD and CEO said, "We are elated to add Dr Mosessian to our regulatory team targeting FDA approval of AlloRx Stem Cells. She has been instrumental in establishing a strong working relationship between Vitro Biopharma and the FDA. She will also be a key driver of the execution of our pending Phase I trial and future INDs targeting additional indications of AlloRx Stem Cells."

Dr. Mosessian said, "I am inspired by Vitro Biopharma's mission to deliver innovative solutions and access to regenerative therapies to deliver unmet needs of the vulnerable patients. I feel fortunate to become part of the team thriving to achieve such an ambitious goal."

John Evans C.F.O. and Chairman of the Board said "We are pleased to have Caroline join the Board of Directors of the company, she adds such a wide breadth of experience in the regulatory, clinical and legal areas of board governance.

ABOUT VITRO BIOPHARMA

Out of years of research, we developed our patent-pending and proprietary line of umbilical cord derived stem cells AlloRx Stem Cells now being used in offshore regenerative medicine clinical trials. Our stem cells are used in regenerative medicine clinical trials with our partner in the Cayman Islands http://www.DVCStem.com. We have a recently approved clinical trial using our AlloRx Stem Cells to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas http://www.tmp-bahamas.com in Nassau. Our nutraceutical stem cell activation product, STEMulize complements AlloRx Stem Cells as an adjuvant therapy to optimize therapeutic outcomes.

Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to critically ill Coronavirus patients and other conditions including multiple sclerosis, OA, Crohn's disease, and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified and we are FDA registered. Our stem cells have been shown to be safe and effective in Phase I clinical trials.

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward-looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues, and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:Dr. Jack Zamora, MDChief Executive OfficerVitro Biopharma, Inc.(303) 999-2130 x 1www.vitrobiopharma.com

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/638885/Vitro-Biopharma-Retains-Leading-Health-Care-Executive-as-Acting-Director-of-Regulatory-Affairs-Director

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Vitro Biopharma Retains Leading Health Care Executive as Acting Director of Regulatory Affairs & Director - Benzinga

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Positive Results From Stem Cell Trial for Knee Osteoarthritis – Pain News Network

Sunday, April 4th, 2021

By Pat Anson, PNN Editor

A California stem cell company has announced positive results from a small, early-stage clinical trial of an experimental stem cell therapy for knee osteoarthritis.

The Phase 1/2a trial conducted by Personalized Stem Cells (PSC) involved 39 patients with knee osteoarthritis who were given a single injection of autologous mesenchymal stem cells derived from their own body fat. Safety was the primary objective of the trial and there were no serious adverse events reported by the company.

The secondary objective of the trial was to assess the effectiveness of the therapy with the Knee Injury and Osteoarthritis Outcome Score (KOOS), a survey that asks patients about their pain, other symptoms, daily function, quality of life, and recreational activities. Nearly 80% of study participants improved above the minimal important change (MIC), with an average improvement over baseline of 2.2 times the MIC.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

Results from the PSC study have been submitted to the FDA for review. The company hopes to get approval for a larger, Phase 2 randomized study of its stem cell therapy later this year.

We are pleased at the strong safety profile and efficacy results in this FDA-approved clinical study of stem cell therapy for knee osteoarthritis, said PSC founder and CEO, Dr. Bob Harman. We are proud to have reached this milestone in our first FDA approved clinical trial. This data supports our progress in the larger placebo-controlled clinical study.

While the FDA has approved hundreds of clinical trials of stem cells, it has not approved a single stem cell product as a treatment for arthritis or any orthopedic condition. That hasnt stopped stem cell clinics from offering regenerative medicine to patients or veterinarians from using it on animals.

VetStem Biopharma, the parent company of PSC, pioneered the use of adipose derived stem cells in veterinary medicine. Its laboratory has processed stem cells for nearly 14,000 dogs, cats, horses and other animals for use by veterinarians in the U.S. and Canada.

The 15 years of veterinary experience with adipose derived stem cell therapy of our parent company, VetStem Biopharma, provided the basis for our FDA study submission and approval and provided valuable insights into the study design and conduct, said Harman.

In addition to the Phase 2 trial for osteoarthritis, PSC plans to pursue FDA approval for a stem cell trial to treat traumatic brain injuries in humans. A clinical study using PSCs stem cell platform to treat respiratory distress syndrome in COVID-19 patients is currently underway.

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Positive Results From Stem Cell Trial for Knee Osteoarthritis - Pain News Network

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