Category Archives: Stem Cell Treatments

By: New York Times | Published: April 2, 2020 10:59:26 pm On Saturday, the FDA took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done.

Written by Katie Thomas

An experimental stem cell therapy derived from human placentas will begin early testing in patients with the coronavirus, a New Jersey biotech company said Thursday.

The treatment, being developed by the company Celularity, has not yet been used on any patients with symptoms of COVID-19, but it has caught the attention of Rudy Giuliani, President Donald Trumps personal lawyer. Giuliani recently featured an interview with the company founder on his website and said on Twitter that the product has real potential, while also criticizing the Food and Drug Administration for not moving more quickly to approve potential remedies.

There is no proven treatment for the respiratory disease, but several experimental approaches, including old malaria drugs and HIV antivirals, are being tested in patients around the world.

READ | Video from Japan shows how COVID-19 is getting transmitted through a third route

Celularity has also enthusiastically publicized the news of its early-stage trial for its treatment, known as CYNK-001. In an email Wednesday to a reporter, its public relations firm described a development as the first FDA approval for COVID-19 cell therapy. The agencys decision, however, merely gives a green light for its product to be used in a clinical trial, not widely prescribed to patients.

In recent weeks, the established scientific process of evaluating a drugs safety and effectiveness has been upended by Trump, who has repeatedly promoted the potential of two long-used malaria drugs that have shown mainly anecdotal evidence of helping patients. On Saturday, the FDA took the unusual step of approving those drugs to treat hospitalized patients with coronavirus on an emergency basis, even though no significant clinical trials have yet been done.

The early trial by Celularity which will primarily evaluate safety, as well as an initial look at efficacy will test its therapy in up to 86 patients with symptoms. They will receive infusions of the cell therapy in the hopes it will prevent them from developing the more severe form of the disease, Dr. Robert Hariri, Celularitys founder and chief executive, said in an interview Wednesday.

The objective here is preventative, Hariri said. If the timing of giving this can prevent those patients who have early disease from progressing to the more serious, life-threatening form, it could be a very, very useful tool.

The therapy involves using stem cells from the placenta known as natural killer cells that help protect a developing fetus or newborn from viruses that have infected the mother. Celularity has been testing these cells in cancer patients.

Hariri said the trial, which would not include a placebo control group, will take place at academic medical centers around the country. He said the company expected to see initial results about 30-60 days after the first patients receive their dose. If this study is successful, Hariri said, the company would move to a placebo-controlled study that would evaluate the drugs efficacy against the disease.

At least one outside expert said the approach could present safety risks. Paul Knoepfler, a stem cell researcher at the University of California, Davis, said that patients with coronavirus can develop severe reactions where their immune systems go too far in attacking cells in their lungs, causing damaging inflammation. Other cell therapies tested in China are designed to dampen the immune response. He said one risk with the natural killer cells is they could go in the other direction, exacerbating respiratory problems by massive killing of the patients respiratory cells.

Despite the scant evidence, Giuliani has become an early booster, interviewing Hariri on a podcast published on his website Saturday and praising the treatment on Twitter, saying, this therapy has real potential. In a tweet Saturday, he added, Lets hope FDA can recognize that their cumbersome process designed to keep us safer, if it is not altered dramatically in times of great need, can result in unimaginable loss of human life.

Around the same time, Twitter deleted a post by Giuliani that it said violated its rules. The tweet, from March 27, made unfounded claims about the malaria drug hydroxychloroquine, one of the treatments that Trump has supported.

Hariri said that he has known Giuliani for years and that the appearance on his podcast was a friendly chat between people who know each other and who share a common interest in this particular response to this disease.

He said that he has no business relationship with Giuliani, and that Giuliani is not representing him in any way, either paid or unpaid.

I dont have anything to do with what the mayor tweets or whatnot, and I dont agree or disagree with anything, he said.

Hariri said the company would follow the established process for testing whether a drug works.

We have waited for the FDA to complete their review, which they did in a heroic and quick fashion, he said.

On Wednesday evening the same day the FDA approved his trial Hariri praised the appearance by the agencys commissioner, Dr. Stephen Hahn, on the conservative Fox News talk show The Ingraham Angle.

We are fortunate to have Dr. Hahn at the helm, he tweeted.

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Unproven Stem Cell Therapy Gets OK for Testing in Coronavirus Patients - The Indian Express

OTTAWA, March 31, 2020 (GLOBE NEWSWIRE) -- In recent weeks, a number of claims have been made that stem cells can be used as a treatment for the coronavirus disease (COVID-19). Globally, there is no clinically tested and government approved stem cell-based treatment for COVID-19.

The Stem Cell Network (SCN) urges extreme caution to those who are considering purchasing products or services advertised as a preventative or curative treatment for COVID-19. In alignment with other international stem cell and regenerative medicine organizations, SCN strongly opposes the marketing of unproven therapies and urge consumers and patients to consult with their doctor or specialist if they have questions or concerns about their health. The best way to combat the spread COVID-19 is to follow the careful advice given by Canada's Chief Public Health Officer.

Researchers across the globe are collaborating and working hard to find legitimate treatments for COVID-19, but this will take time. It is important to note that when a treatment does become available, it will be announced through recognized medical authorities, such as the World Health Organization, which is coordinating global efforts and actively compiling a database of published research on COVID-19.

For the most up-to-date information on COVID-19, please consult:World Health OrganizationPublic Health Agency of Canada

To learn more about clinical trials or stem cells:Stem Cell Network Clinical Trial FAQsCloser Look at Stem Cells

About the Stem Cell NetworkTomorrow's health is here. The Stem Cell Network (SCN) is a national non-profit that supports stem cell and regenerative medicine research, training the next generation of highly qualified personnel, and delivering outreach activities across Canada. SCN's goal is to advance science from the lab to the clinic for the benefit of Canadians. SCN has been supported by the Government of Canada since inception in 2001. This strategic funding, valued at $118M has benefitted approximately 170 world-class research groups and 3,000 trainees and has catalyzed 23 clinical trials. stemcellnetwork.ca

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Stem Cell Network Warns that Claims of Stem Cell Treatments for COVID-19 Are Unfounded and Misleading - Benzinga

Maggie L. Shaw

Mantle cell lymphoma is a type of B-cell non-Hodgkin lymphoma with a typically poor prognosis. Even with an allogeneic stem cell transplant, patients can become resistant to chemotherapy. Most do not survive 4 or 5 years after diagnosis, and the 10-year survival rate hovers between 5% and 10%.

Chimeric antigen receptor (CAR) T-cell therapy has been making great inroads as targeted treatment for many types of cancers highly resistant to other treatments, by prolonging patient survival and increasing their quality of life. Until now, similar results have not been seen in patients with MCL. However, with their successful phase 2 ZUMA-2 trial results just published in the New England Journal of Medicine, a group of researchers led by Michael Wang, MD, from The University of Texas MD Anderson Cancer Center, are able to show that these patients can benefit from the specialized therapy.

In this study conducted in the United States and Europe, the patient population had relapsed/refractory progressive disease despite receiving Brutons tyrosine kinase (BTK) inhibitor therapy and from 3 to 5 prior therapies.

BTK inhibitor therapy has greatly improved outcomes in patients with relapsed or refractory mantle cell lymphoma, yet patients who have disease progression after receiving the treatment are likely to have poor outcomes, with median overall survival of just 6 to 10 months, the authors said.

The median patient age was 65 years (range, 38-79). They were evaluated for response to a single infusion of KTE-X19, an anti-CD19 CAR T-cell therapy, that was dosed at 2106 CAR T cells/kg of body weight. Seventy-four patients were enrolled between October 24, 2016, and April 16, 2019; the treatment was manufactured for 71 and ultimately administered to 68.

There was a follow-up after 60 patients were monitored for 7 months, at which time a primary efficacy analysis was conducted. The primary endpoint was objective response (complete [CR] or partial [PR]), which was confirmed via bone marrow evaluation and positron emission tomography-computed tomography.

Overall, 85% of the entire study cohort of 74 patients was able to reach an objective response to KTE-X19, 59% of whom had a CR. These numbers were even higher among the group of 60 patients. Ninety-three percent (95% CI, 84%-98%) achieved an objective response, which was evaluated by an independent radiologic review committee. And of this group, 67% (95% CI, 53%-78%) had a CR.

The median times to response were impressive, with there being 1 month (range, 0.8-3.1) to initial response and 3 months (range, 0.9-9.3) to CR. In addition, of the 42 patients who initially had a PR or stable disease (SD), 24 (21 who had a PR, 3 who had SD) progressed to a CR in a median 2.2 months (range, 1.8-8.3).

Progression-free (PFS) and overall survival (OS) results also show promise to treatment with KTE-X19. As of the data cutoff date, there was evidence of remission in 78% patients who had a CR, with similar results seen in 57% of patients from the primary efficacy analysis. Overall, at 12 months, the PFS and OS were 61% and 83%, respectively.

Common adverse events to the treatment of grade 3 or higher included cytopenias (94%) and infections (32%). Ninety-one percent also experienced cytokine release syndrome, with a median time to onset of 2 days (range, 1-13) for any grade and 4 days (range, 1-9) for at least grade 3, but none died as a result. According to the study authors, most symptoms were reversible.

ZUMA-2 is the first multi-center, phase 2 study of CAR T-cell therapy for relapsed/refractory mantle cell lymphoma, and these efficacy and safety results are encouraging, stated Wang. Although this study continues, our reported results, including a manageable safety profile, point to this therapy as an effective and viable option for patients with relapsed or refractory mantle cell lymphoma.

Reference

Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382;1331-1342. doi: 10.1056/NEJM0a1914347.

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Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? - AJMC.com Managed Markets Network

Dive Brief:

First-generation autologous CAR-T therapies involve genetically edited immune cells taken directly from patients in a lengthy, logistically challenging and costly procedure. Fate is one of a group of companies advancing an "off-the-shelf" cell therapy approach, which utilizes cells taken from healthy donors.

It's an emerging field of research that's still in its early stages. Only slivers of human data have been published thus far. These companies have yet to prove off-the-shelf approaches can match, or surpass, what has been seen with CAR-T without triggering serious or potentially deadly immune reactions.

But pharma has made notable investments in the work, which could lead to treatments that are quicker and less costly to produce than their autologous counterparts. Among them: Pfizer's wide-ranging deal with Allogene Therapeutics in 2018 as well as Bayer's buyout of BlueRock Therapeutics and investment in Century Therapeutics last year.

Entering this year, the allogeneic field looked set to take some steps forward. As analyst firm Jefferies noted in March, Precision,AllogeneTherapeutics and CRISPRTherapeutics, which each use different off-the-shelf approaches, could all produce notable human data this year.

The coronavirus pandemic, however, has threatened clinical research timelines across the industry, disrupting study enrollment and treatment.

Fate is in the mix, too, though it acknowledged COVID-19 could impact its plans. In announcing the J&J deal, Fate also warned of coronavirus-related "delays or disruptions in patient enrollment and site initiation" that will affect the timing of its clinical trials. It didn't provide specific details.

The J&J partnership does give Fate some breathing room. The San Diego biotech is getting $100 million to produce up to four new therapies that J&J will have the option to license, while J&J covers the associated R&D costs. Fate could receive another $3 billion in various conditional payments tied to regulatory and sales milestones if all goes to plan, though those payments may never materialize.

"From speaking to management, we think this is exactly the type of deal [Fate] was looking for," wrote Cantor Fitzgerald analyst Alethia Young, referring to a back-loaded agreement that gives the company the chance to keep some rights to the programs in the alliance.

Young wrote the deal is also "a strong validation" of Fate's approach, which draws from stem cell and CAR-T technologies.Fate turns cells from donors into induced pluripotent stem cells, which in turn can be re-engineered into a variety of different cells. In their partnership, for instance, Fate and J&J aim to create certain types of immune cells natural killer, or NK cells, and T cells that can hunt down tumors.

The partnership doesn't include any of the other treatments currently in Fate's pipeline. Shares climbed about 20%, to around $25 apiece, in pre-market trading Friday.

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Fate inks $100M J&J pact for 'off-the-shelf' cancer cell therapies - BioPharma Dive

Parker Hannifin has sponsored this post.

Cell therapies promise treatments for serious illnesses, but require automation and manufacturing expertise to scale up production for research and products. (Image courtesy of Parker Hannifin.)

Cellular therapies and bio-fabrication are two of the most revolutionary treatments for serious illnesses to be developed in the early 21st century, offering the hope of cures where once only symptomatic treatments were available. The 2006 discovery of Induced Pluripotent Stem Cells (iPSCs) formed a catalyst for research and development into these new therapeutic approaches. Stem cell therapies offer promising avenues for the treatment of devastating illnesses such as diabetes, cancer, heart disease and even neurological diseases.

Tailored cell therapies using iPSCs are considered to be the new Third Pillar of the drug and treatment industry, standing alongside small molecules and biologics as tools for treatment. However, the widespread research and treatment using cell therapies requires mass-produced iPSCs to be available in quantitywhich means advanced manufacturing techniques.

Cells are tiny living, complex organisms; they must be handled with precision and accuracy. Automated handling equipment needs a heightened level of dexterity and control. (Image courtesy of Parker Hannifin.)

Scaling up the production of iPSCs requires investmentsome of which is already in place with two deals: $70 million to the New Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to advance U.S. leadership in the biopharmaceutical industry, and an 87-member coalition funded by the Defense Department called ARMI-BioFab USA, which aims to develop the next-generation techniques needed to repair and replace cells, tissues and organs for wounded military service veterans.

The key to success in the scale-up of production is advanced automation, which will improve the manufacturing process used to fabricate cell colonies.

Currently, most research and cell fabrication involves a significant amount of manual work and decision-making, which can be error-prone and represents a bottleneck in attempts to scale these fabrication processes.

One way to improve the manufacturing processes related to cell therapies is by partnering with experienced automation and manufacturing industry leaders, who can share their expertise. An example of this is the partnership between Parker Hannifin and CellX Technologies. Together, these companies have developed a platform to help researchers and clinicians quantify key morphological stem cells, automate the handling process and perform cell maintenance.

Current cell therapy research is hampered by difficulties with a lack of large field-of-view and high-resolution optics when imaging live cell cultures. This makes it difficult to monitor and quantify changes to the cells. Available devices and equipment for sampling, transfer or deletion of specific cells or colonies also lack the rigorous accuracy that manufacturing-scale production would require. Instead, visual assessment and manual transfer by lab technicians is the usual methodsacrificing speed and production volume.

An automated, image-based system would enable accurate quantitative metrics of biological performance and will be applicable at a cell-by-cell or a colony-by-colony basis, among other benefits.

Automated cell-handling equipment needs to be precise and finely calibrated in order to handle delicate cells with the necessary dexterity and control. Three primary handling techniques are used for this very difficult automation task:

Combining capabilities for these three functions into a single platform will enable multiple benefits, including improved reproducibility and quality of cells for research and products, reduce variability and costs from manual processes, improved lot traceability and documentation, and define quantitative process quality attributes and metrics.

Parker Hannifins expertise in manufacturability, digital pathology and additive manufacturing lends itself directly to the development of the CellX platform. CellX enables automation of the scanning and identification processes, and pairs this with cell selection and precision placement.

The CellX Device, developed by Parker Hannifin and CellX Technologies, combines large field-of-view imaging with precision instrumentation, fluidics, and documentation and control capabilities. (Image courtesy of Parker Hannifin.)

CellX also needed customization of standard products. Parker Hannifin has decades of experience in close tolerance special purpose fluidics and actuator technology, and developed enabling technology for the CellX central core, which consists of a high-quality automated inverted microscope and CCD camera with brightfield and fluorescent imaging capabilities.

Some of the specialized equipment that Parker Hannifin helped develop for CellX includes a load and removal station for disposable cell-picking tips, and environmentally controlled workspace to maintain sterility and oxygen levels, and an integrated sensor to accurately locate each new tip.

The combined precision and imaging capabilities of the CellX platform enable rapid data collection and high repeatability, which means researchers can rely on accurate data, healthy cell colonies and quantitative, reproducible standards for cell therapy development. Parker Hannifin has a proven history of developing new tools and instruments for manufacturing processes with their partner OEMsand in the case of CellX, accelerating the development of the future of cell therapies.

To learn more about Parker Hannifins development of the CellX platform, including use cases and details on the full complement of customized equipment and enabling features, download the full whitepaper from Parker Hannifin.

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Cell Therapies Can Revolutionize Treatment, Automation Needed to Scale Production - ENGINEERING.com

The Angels announced that starter Griffin Canning is getting a biological injection in his ailing elbow and will be re-evaluated in 3-4 weeks time. Canning was recently diagnosed with both UCL and joint issues in his pitching elbow.

The phrasing of the announcement is interesting. The word biological generally leads me in two different directions with this sort of injury. Many baseball players have been treated with platelet-rich plasma (PRP) injections for a variety of issues in recent years, but the Angels have also used stem cell injections to try to treat UCL woes.

Andrew Heaney, Garrett Richards and Shohei Ohtani all got stem cell treatments for their elbows. All three also eventually wound up getting Tommy John surgery. Im not willing to go as far as the LA Times article did in condemning the treatments as useless, seeing as a sample size of three is rather small. Theyre also not the only players who have ever been treated with stem cells. CC Sabathia, for instance, got a stem cell injection for his bad knee.

Regardless of what the treatment is or isnt, its a positive sign that Cannings injury wasnt deemed dire enough to immediately merit surgery. Canning isnt going to be ready for Opening Day either way, but if the injection works he may be able to pitch at some point this season. Goodness knows that the Angels rotation needs all hands on deck, even after the team signed both Dylan Bundy and Julio Teheran this winter.

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Marc Topkin of the Tampa Bay Times reports that the Rays have initiated contract extension talks with outfielder Austin Meadows. Meadows said, I definitely would be open to something like that. Extension talks havent gotten deep yet, just some initial stuff, as Meadows put it.

Meadows, 24, wont become arbitration-eligible until after the 2021 season and wouldnt become eligible for free agency until after the 2025 season. However, as teams have shown in recent years, signing productive young players to contract extensions can save them a lot of money down the road.

Last season, Meadows broke out, batting .291/.364/.558 with 33 home runs, 89 RBI, 83 runs scored, and 12 stolen bases in 591 plate appearances. Only nine outfielders (min. 500 PA) had a better OPS than Meadows. Seems like a player one would want to continue to play for ones team.

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Griffin Canning to receive biological injection in elbow, will be re-evaluated in 3-4 weeks - NBCSports.com

Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues and tumors, wherein their toxicity, impurity, and other aspects are studied.

With the growing number of successful stem cell therapy treatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

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Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

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Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market Competitive Analysis and Forecast 2017-2025 - Monroe Scoop

Trial measures safety and efficacy of device and point-of-care cellular therapy to help reduce pain and improve function in osteoarthritic knees

LOUISVILLE, Colo. andNEW ORLEANS andSAN ANTONIO andCHICAGO, March 2, 2020 /PRNewswire/ -- GID BIOannounced today that The American Journal of Sports Medicinepublished resultsof its FDA-approved multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring the safety and efficacy of its SVF-2 device and point-of-care (POC) therapy intended to treat pain and function associated with knee osteoarthritis.

The Phase IIb clinical study was approved by the FDA under an IDE and is the first regenerative cell therapy for osteoarthritis to meet study endpoints using autologous stromal cells from adipose tissue. The cellular therapy for osteoarthritis procedure showed no serious adverse events at two years and a significant reduction in pain at one year. A Phase III pivotal study begins soon at Tulane University School of Medicinewith additional trial sites participating nationwide.

"Publishing this data signifies real science and a breakthrough in regenerative medicine. We've completed a prior safety trial, an FDA-approved Phase IIb trial, and are now beginning a Phase III pivotal trial. Physicians will be able to use the SVF-2 technology to provide a cellular therapy option for patients," said principal investigator for the Phase III trial, Jaime R. Garza, MD, DDS, FACS, Professor of Orthopedic Surgery and Center for Stem Cell Research and Regenerative Medicineat Tulane University School of Medicine. "I am very proud to collaborate with my alma mater, Tulane University, and the School of Medicine's outstanding orthopedic department led by Dr. Felix Savoie, and its worldclass Center for Stem Cell Research and Regenerative Medicine directed by expert cell scientist Dr. Bruce Bunnell," said Dr. Garza.

Dr. Garza is a former NFL player and a Tulane University Athletic Hall of Fame inductee. He is also a clinical professor of plastic surgery and otolaryngology at the University of Texas Health Science Center.

Treatments by clinics using stem cells are under scrutiny by the FDA as its discretionary enforcement period expires in November of this year. The intent is that hundreds of stem cell clinicsnationwide become compliant with FDA regulations, leading to clinical data support of safety and efficacy.

"Our randomized, controlled clinical trial is the first cellular therapy study for osteoarthritis to meet study endpoints using autologous adipose stromal cells for a point-of-care therapy.Eighty-eight percent of subjects responded greater than placebo at one year and reported a median 87% improvement in pain, stiffness and function," said William W. Cimino, Ph.D., CEO of GID BIO. "We are able to isolate and concentrate the right types and numbers of cells to create an effective therapy. We are pleased to begin Phase III trials with Dr. Garza, and to be at the forefront for a cellular therapy option for osteoarthritic knees."

About GID SVF-2 and POC TherapyGID technology has reduced a Good Manufacturing Practice (GMP) cell-processing facility to a single-use disposable device for scalable point-of-care cell processing. The technology uniquely harvests and isolates stromal cells from a patient's own adipose tissue that is then reimplanted by injection in a physician's office in less than two hours. Stromal cells play an essential role in the body's natural healing response, with a dynamic and reactive ability to participate in the healing process. The American Medical Associationgranted GID two new CPT class III codesthat became effective January 2020 as a step toward Medicare reimbursement.

Story continues

About GID BIOGID BIO develops next-generation cellular therapies for degenerative musculoskeletal, dermal, and organ-specific diseases, with the goal of making cellular medicine available to as many people as possible. GID's SVF-2 device and POC therapy harnesses the innate healing power of a patient's own stromal cells. Information on GID's SVF-2 device, biologic cellular implants, POC therapy, osteoarthritis clinical program and GID's pipeline for treating degenerative disease in musculoskeletal conditions includes other indications including, dermal and organs, specifically, wound care and diabetes. Learn more: https://www.HealingIntelligently.com.

AboutTulane University School of MedicineOne of the nation's most recognized centers for medical education,Tulane University School of Medicineis a vibrant center for education, research and public service.Tulane School of Medicineis the second-oldest medical school in the Deep South and the 15th oldest medical school inthe United States.Tulane School of Medicinerecruits top faculty, researchers and students from around the world, and pushes the boundaries of medicine with groundbreaking medical research and surgical advances.Tulaneremains in the forefront of modern medical innovation and is equipping the next generation of medical professionals with the tools to succeed in the rapidly changing future of health care.

About American Journal of Sports MedicineAglobal organization with 3,000 members that generates evidence-based knowledge and promotes emerging research to educate orthopaedic surgeonsand a resource for the orthopaedic sports medicine community, American Journal of Sports Medicine is a peer-reviewed scientific journal, first published in 1972. It is the official publication ofAOSSMfeaturing 14 issues per year. The journal acts as an important forum for independent orthopaedic sports medicine research and education, allowing clinical practitioners the ability to make decisions based on sound scientific information.

Contact:Kellee Johnson, 312-751-3959 or kjohnson@ballastgroup.com

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"American Journal of Sports Medicine" publishes results of an FDA-approved clinical trial for treating osteoarthritis knee pain - Yahoo...

Note to editors and reporters: Live coverage on NASA Television of the SpaceX CRS-20 cargo launch carrying this experiment is scheduled at 8:30 p.m. EST, 11:30 p.m. PST March 6 and will be replayed twice on March 7. Coverage of the rendezvous with the International Space Station will be at 5:30 a.m. EST Monday, March 8, with installation at 8:30 a.m. All times are subject to change due if weather or launch conditions are unfavorable

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Space exploration can take a toll on the human heart. Astronauts are at risk for changes in their cardiac function and rhythm. To learn how microgravity and other physical forces in space exact their effects on heart muscle, a Tissue Chips in Space project has now been packed and is awaiting launch to the International Space Station.

The experimental equipment consists of small, compact devices, a little bit larger than cell phone cases. The holders contain a row of tiny, 3-D globs of beating heart tissue grown from pluripotent stem cells, generated from human adult cells. The heart muscle tissue is supported between two flexible pillars that allow it to contract freely, in contrast to the rigid constraints of a Petri dish.

The devices also house a novel invention from the University of Washington. It automatically senses and measures the contractions of the heart tissues, and reduces the amount of time the astronauts will need to spend conducting this study.

The flexible pillars contain tiny magnets, explained UW graduate student Ty Higashi, one of the inventors. When the muscle tissue contracts, the position of the embedded magnets changes, and the motion can be detected by a sensor, he said. That information is then sent down to a laboratory on Earth.

This model will recapitulate, on a miniature scale, what might be happening to the architecture and function of heart muscle cells and tissues in astronauts during a space mission.

The project head is Deok-Ho Kim, a professor in bioengineering, who recently joined the Johns Hopkins University faculty in Baltimore. He and co-investigator, Nathan Sniadecki, a professor in mechanical engineering, began this study two years at the UW Medicine Institute for Stem Cell and Regenerative Medicine (ISCRM). Jonathan Tsui, a postdoc in bioengineering, Ty Higashi, a graduate student in mechanical engineering , and other members of the UW project team, continue the cross-country collaboration in Seattle. The team is working with several NASA and National Institutes of Health groups, and researchers at other universities, on this effort.

Sniadecki said that each of the tissues heading to the International Space Center contain about a half million heart cells.

They act like a full tissue, he explained. They contract, they beat and you can actually see them physically shorten in the dish. Were actually able to see little heart beats from these tissues.

The SpaceX shuttle delivering this scientific payload is expected to leave from Cape Canaveral no earlier than 8:50 p.m. PST (11:50 p.m. EST) Friday, March 6. The exact departure schedule depends on the weather and other factors.

Once on board, the experiment will run for 30 days before being returned to Earth for further analysis. A related space-based experiment will follow skyward later, to see if medications or mechanical interventions can offset what the heart muscle endures during extended space missions.

The space program is looking at ways to travel longer and farther, Sniadecki said. To do so, they need to think about protecting their crews. Having treatments or drugs to protect astronauts during their travel would make long term space travel possible.

Guarding against cardiac problems would be especially critical during space travel at distances never attempted before, such as a mission to Mars, said Sniadecki. This opportunity to really kind of push the frontier for space travel is every engineers dream.

He added, We also hope to gather information that will help in preventing and treating heart muscle damage in people generally, as well as in understanding how aging changes heart muscle.

Microgravity is known to speed up aging, and likely influence other cell or tissue properties. Because aging is accelerated in space, studies on the International Space Station is a way to more quickly assess this process over weeks, instead of years.

I think the medicine side of it is extremely helpful on Earth, too, because what we discover could potentially lead to treatments for counteracting aging, Sniadecki said.

This space medicine research project is funded by the National Center for Advancing Translational Sciences and the National Institute of Biomedical Imaging and Bioengineering. This heart tissue study is part of the national Tissue Chips in Space program.

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3D beating heart tissue experiment heads to Space Station - UW Medicine Newsroom

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Known mutations of the novel coronavirus have not affected overall progress of drug and vaccine development, and scientists will keep monitoring the virus's evolution and plan research projects accordingly, senior scientists said on Friday.

This week, Chinese scientists announced that they had discovered that the virus had evolved into two major subtypes, and detected 149 mutation points across its genomes. The L subtype, considered more aggressive, is believed to have been more prevalent during the early stages of the outbreak in Wuhan, Hubei province, than its S subtype ancestor, which is relatively more prevalent now.

Zhou Qi, deputy secretary-general of the Chinese Academy of Sciences, said the virus's mutations require further research, and China is conducting a coordinated research effort to evaluate the virus and develop a vaccine.

"All research is under control," he said. "The mutations that we now know have not affected our drug, antibody or vaccine development. We will keep monitoring the mutations the virus generates and plan related research projects accordingly."

Zheng Zhongwei, director of the Development Center for Medical Science and Technology of the National Health Commission, said China has nine ongoing research projects on vaccine development, and some will hopefully enter clinical trials in April.

The five main types of vaccines that China is working on are an inactivated vaccine, recombinant subunit vaccine, adenoviral vector vaccine, live attenuated vaccine and nucleic acid-based vaccine.

Zheng said he had not seen reports of foreign researchers working on an inactivated vaccine, which consists of virus particles that no longer have disease-producing capability. As for the recombinant and vector vaccines, he said both have moved into animal trials and their progress is on par with that of other countries.

For drug development, China has expanded the use of trial drugs and treatments, including plasma transfusion, artificial extracorporeal liver support often called liver dialysis and traditional Chinese medicine, said Sun Yanrong, deputy director of the China National Center for Biotechnology Development.

Advanced treatments such as stem cell and monoclonal antibody therapies are also being researched as a way to save patients in critical condition, she added. Chloroquine phosphate has moved from trials to clinical treatment, and no obvious side effects were found in the 285 severely ill patients taking the drug.

Scientists have expanded clinical trials for favipiravir a Japanese antiviral drug that showed promise against the virus in clinical trials in Shenzhen, Guangdong province to cover patients in Wuhan.

Doctors from hospitals in Beijing and Harbin, Heilongjiang province, are doing clinical trials for stem cell therapy and preliminary results have found the treatment safe and effective, Sun said, adding that its use will be expanded in Wuhan.

Clinical results for artificial liver support show it can significantly reduce the treatment time for critically ill patients and improve their recovery rate, she said.

Tocilizumab, a drug that suppresses overreactions of the immune system, has recently been added to the latest treatment and diagnosis guideline of the National Health Commission. It helps to inhibit a deadly medical condition called a cytokine storm an overproduction of immune cells that damages healthy tissues which is also one of the main causes of death for critically ill patients.

Sun said around 272 severely ill patients are being treated with Tocilizumab. The patients came from 14 hospitals in Wuhan, Zhou added. Early clinical data showed that 20 severely or critically ill patients had fevers lowered within a day after receiving the drug, and 19 patients had recovered within two weeks.

Contact the writers at zhangzhihao@chinadaily.com.cn

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Mutations of virus do not stymie research -