RoosterBio Launches the Regenerative Medicine Industry’s First Xeno-Free hMSC Cell Banks to Advance and Simplify … – PR Web (press release)

Frederick, Maryland (PRWEB) May 04, 2017

At a CAGR of 23.2% and estimated revenue of $68B by 2020, the Regenerative Medicine (RM) industry continues to call for new tools designed to accelerate this aggressive growth. Based on strong RM market demand, RoosterBio Inc today announces the launch of xeno-free (XF) human bone-marrow derived mesenchymal stem/stromal cell (hMSC) products.

The RoosterVial-XF line of products are cryopreserved human bone marrow-derived MSCs, designed to serve as manufacturing starting materials, and are offered in various high volume formats, including 1, 10 and 50 million cells per vial. These first-in-class xeno-free hMSC cell bank product offerings expand RoosterBios development grade product portfolio and are complementary to RoosterBios other industry-leading stem cell bioprocessing systems.

First generation cell therapies traditionally relied on bovine serum in their manufacturing processes. As the industry evolves, the market is seeking more sophisticated XF tools and processes. RoosterBio is bringing these XF design requirements into its biomanufacturing product configurations with the goal of reducing regulatory burden and enhancing the long-term safety profile of cell-based therapies. By incorporating XF starting materials at early stages of product development, RM scientists can perform more clinically relevant work, resulting in an expedited path towards clinical testing programs.

Jon A Rowley, RoosterBios Chief Technology Officer, states, Were very excited to launch this product line, particularly as it relates to advancing the RM industry. Last year, we launched XF bioprocess media, and now were introducing the XF cell banks to complete the system. Together, these products give our customers all the tools they need to develop their RM products, whether they are developing cellular therapies, cell-based gene therapies, hMSC-derived exosomes, or bioprinted engineered tissues.

The release of these products reinforces RoosterBios ongoing mission to support the acceleration of the Regenerative Medicine industry.

To learn more about RoosterBio Inc., please contact us at +1 301-360-3545 or info(at)roosterbio(dot)com.

About RoosterBio, Inc.: RoosterBio, Inc. is a privately held stem cell tools and technology company focused on accelerating the development of a sustainable regenerative medicine industry, one customer at a time. RoosterBios products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how stem cells are purchased, expanded, and used in development, leading to marked time and costs savings for customers. RoosterBios innovative products are ushering in a new era of productivity and standardization into the field, accelerating the road to discovery in Regenerative Medicine. For more information on RoosterBio and adult stem cells, please visit http://www.roosterbio.com, follow on twitter (@RoosterBio), or read our corporate blog (http://www.roosterbio.blogspot.com).

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RoosterBio Launches the Regenerative Medicine Industry's First Xeno-Free hMSC Cell Banks to Advance and Simplify ... - PR Web (press release)

Cellular Biomedicine Group: A Transpacific Cell Therapy Company – Investing.com

Cellular Biomedicine Group (NASDAQ:) has seven preclinical CAR-T programs and two Phase I clinical trials using its CD19 CAR-T therapy in China, making it the only US-traded CAR-T company in this market. It has rights to the Dendristim lung cancer vaccine. In addition, it is adapting its osteoarthritis (OA) treatment ReJoin as an allogeneic product, AlloJoin, which will be developed in the US after an IND in 2017 or 2018.

Chinese CAR-T trials ongoing

The company has two ongoing Phase I studies using its CD19 CAR-T therapy for the treatment of diffuse large B-cell lymphoma (DLBCL) and adult acute lymphoblastic leukemia (ALL). None of the major CAR-T developers currently running trials in the US and Europe have initiated studies in China, positioning CBMG as an early entrant into the market. Data are expected for the trials in Q417.

AlloJoin: Off-the-shelf OA cell therapy

AlloJoin is a cell line derived from human adipose-derived mesenchymal progenitor cells. The companys autologous version of these cells (ReJoin) previously showed improvement in cartilage growth (p=0.007) in patients with knee OA in an early clinical trial. CBMG is developing AlloJoin as an off-the-shelf version of this product and received a grant of $2.29m from the California Institute for Regenerative Medicine to support US development. The interim results from the Phase I trial (n=18) reported no serious adverse events and the most common adverse events were pain (77%) and swelling (52%). The trial is expected to be complete in Q317.

Chinese GMP cell production

One of the unique strengths of the company is its efficient manufacturing. It has three GMP-certified facilities in China, with significantly improved production costs compared to US facilities. CBMG estimates it can provide 10,000 doses of cells per year for the Chinese market (export of human cells from China is highly restricted). This capacity has recently attracted a partnership with GE Healthcare Life Science China to develop control processes for cell manufacturing.

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Cellular Biomedicine Group: A Transpacific Cell Therapy Company - Investing.com

GARM Now Offering Elite Athletes Stem Cell Treatment with US Olympic Orthopedic Surgeon – Benzinga

Global Alliance for Regenerative Medicine, known as GARM, is now offering stem cell therapy for elite athletes with a US Olympic orthopedic surgeon Glenn Terry MD. The treatments are being offered in the Caribbean with extremely high cell counts for the highest effectiveness.

Roatan, Honduras (PRWEB) May 04, 2017

Global Alliance for Regenerative Medicine, known as GARM, is now offering stem cell therapy for elite athletes with US Olympics doctor Glenn Terry MD. The treatments are being offered in the Caribbean with extremely high cell counts for the highest effectiveness. Call (877) 737-0441 for more information and scheduling.

Regenerative medicine treatment at GARM is performed with one's own adipose tissue. The tissue is rich with stem cells, and with processing amounts to well over 500 million stem cells per treatment. Board Certified expert Dr. Glenn Terry provides the treatments along with Dr. James Andrews.

Dr. Terry and Dr. Andrews are virtually household names in the US, having provided treatments for innumerable athletes in the NFL, MLB, NBA, WWE, PGA, NCAA and many Olympic athletes. Dr. Andrews has been featured in USA Today, HBO, ESPN, all the national networks and has trained hundreds of expert orthopedic surgeons. Dr. Terry was the Head US Olympic Physician for several games, and co-founded the venerable Hughston Sports Medicine Clinic in Georgia.

The adipose SVF stem cell treatments are performed in one setting. Over 500 million stem cell counts are achieved with the treatments, and culturing is not necessary. The therapy works exceptionally well for joint arthritis, knee meniscal tears, degenerative disc disease, ligament sprains, rotator cuff injuries and other sports injuries. Even sports specific injuries like turf toe and throwing overuse injuries respond amazingly well.

GARM is currently offering a complimentary phone consultation and MRI review. Direct flights are available to Roatan from several US cities including Atlanta, Houston, Dallas, NYC, Toronto and Montreal. Call (877) 737-0441 for more information and scheduling.

For the original version on PRWeb visit: http://www.prweb.com/releases/stem-cell-therapy/elite-athletes/prweb14274741.htm

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GARM Now Offering Elite Athletes Stem Cell Treatment with US Olympic Orthopedic Surgeon - Benzinga

California Today: Waiting on the Promise of Stem Cells – New York Times


New York Times
California Today: Waiting on the Promise of Stem Cells
New York Times
In 2004, voters approved Proposition 71, a bond measure amounting to $6 billion with interest, which created a stem cell agency to help fund research. It was in part a response to limits on federal funding for stem cell research imposed by the ...

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California Today: Waiting on the Promise of Stem Cells - New York Times

Scientists Want to Grow Your Music-Blasted Ears Some New Parts – Gizmodo

Ear organoid with hair cells in blue. Image: Indiana University School of Medicine

Hearing loss can be inevitable for some older folks, as well as for their music blasting, phone screen-staring grandchildren. Naturally, many of those whove lost their hearing are keen on getting it back, somehow, with things like hearing aids and cochlear implants.

But what if your doctor could just turn some of your own bodys cells back into sound-sensing hair cells, and transplant them right back into your head?

A team of scientists at Indiana University might be getting closer to that future, using pluripotent stem cells, cells from the body that can be turned back into blank slate cells. The researchers were able to use these cells to create functioning pieces of the inner ear, chock full of hair cells and neurons. True stem cell hearing loss treatment is a long way off, but the result is, as far as they can tell, the first time anyones created hair cells from human pluripotent stem cells. So, a step in that direction.

Its exciting, study co-authors Jeffrey Holttold Gizmodo If were going to use these approaches in the clinic well want to start with human stem cell tissue.

Hearing loss can come from damage to elongated hair cells inside the ear that help with detecting sounds and relaying them to your brain. While some animals regenerate them, humans dont, and we can damage them from loud noises and aging.Scientists have been looking for methods like stem cells and gene therapies to repair them.

For their new study, the researchers started with human stem cells, arranged them in a sort of organic gel matrix like chunks of fruit in Jell-O, and tagged them with a fluorescent gene that would produce a glowing signature if theyd successfully produced certain cell types. They turned the stem cells into little pieces of inner ear by applying proteins at just the right time in a step-by-step process, and after a few weeks of tending to their cellular masses, were able to demonstrate that the little globs had developed into part of an ear. That included hair cells that both looked and acted properly, as well as neurons that send sound signals to the brain, according to results published yesterday in the journal Nature Biotechnology.

If you apply these signals at the wrong time you can potentially generate a brain instead of an inner ear, study author Karl Koehler told Gizmodo. The real breakthrough is that we figured out the exact timing to do each one of these [protein] treatments.

The researchers didnt implant the cells into a human patient or anything, but they still took a hugely important step. The idea, to be able to one day take a tube of blood and make your hair cells and implant is really exciting. I think its the future, Eric Topol, Founder and Director of the Scripps Translational Science Institute in California who was not involved in the study, told Gizmodo. Its a biological remedy to hearing loss.

It will take a long time to actually get to the transplanting stage, warned Holt and Koehler, and its been slow going. Other studies have used mouse cells or have been very preliminary, said Koehler. Its difficult to say whether or not well be able to use stem cell-derived cells to rebuild the inner ear.

Plus, these kinds of discussions always come along with ethical concerns. The World Health Organization suggests that over half of the worlds cases of deafness are preventable. Still, theres an entire American Deaf culture and identity that could be forgotten when we do research like this. Not all deaf people want to regain their hearing, according to reporting done by The Atlantic. I reached out to the National Association of the Deaf whose bioethics committee is looking at the paper, but does not have a response at this time.

Even if treatments like this are a long way off, growing these cells could be important for research, says Holtmainly to continue doing experiments. Its hard to get human inner ear hair cells otherwise. We cant get them from the patients and most people dont want to give up an ear for our experiments.

[Nature Biotechnology]

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Scientists Want to Grow Your Music-Blasted Ears Some New Parts - Gizmodo

Stem cells were one of the biggest controversies of 2001. Where are they now? – Vox

Remember stem cells? They were one of the biggest scientific controversies during the early years of George W. Bushs presidency.

At the time, scientists had realized thatembryonic stem cells had the incredible capacity to transform into virtually any cell in the human body and so could potentially lead to new treatments or cures for a multitude of illnesses. On the other hand, extracting these stem cells required destroying human embryos, an action opposed by some pro-life individuals.

EMBRYONIC stem-cell THERAPIES ARE GETTING TESTED IN ACTUAL PATIENTS

The stem-cell debate got really heated. But then ... it just sort of fizzled out from public view. So whatever happened to stem cells?

A couple of things helped lessen the controversy. By the late 2000s, researchers discovered other ways to createcells similar to embryonic stem cells without destroying human embryos, a promising advance that helped defuse the culture-war aspect. Then, in 2009, Obama somewhat loosened the Bush-era restrictions on federal funding for stem-cell research and thecompromise seemed to quiet both sides down a fair amount.

So, lately, scientists have been patiently continuing their stem-cell research in a less noisy atmosphere. And that work has actually led to a few advances like restoring some sight in 10 patients with vision diseases. But the stem-cell controversy is far from dead. Researchers still might need cells from embryos to create certain treatments. If it turns out that non-embryonic stem cells aren't good enough, that could re-ignite the culture wars. So here's a guide to the debate:

Shinya Yamanaka (right) receiving flowers from Sweden's ambassador to Japan in 2012, after it was announced that Yamanaka won a Nobel Prize in medicine. (Jiji Press/AFP/Getty Images)

Embryonic stem cells attracted scientific attention because they have the potential to grow into virtually any cell in the human body say, insulin-producing cells for people with diabetes, brain cells for people with Parkinsons, or even wholenew organs to replace faulty ones.

But for many people, there was one huge ethical problem: creating them required destroying an embryo. That's why, in 2001,George W. Bush decided to limit federal funding of research to a list of 60 pre-existing embryonic stem-cell lines (so as to discourage the destruction of any more embryos). Many scientists viewed the rules as too strict. Hence the controversy.

Obama SOMEWHAT relaxed Bushs restrictions on embryonic stem cells

But then in 2007, Japanese scientistShinya Yamanaka and his colleagues managed to coax cells from adult humans into embryo-like flexibility. In other words, they were able to create cells that seemed to resemble embryonic stem cells but that didn't require destroying an embryo. (These new cells were named induced pluripotent stem cells, IPSCs.) Other researchers began finding that adult stem cells have similar, but more limited, properties, too.

Meanwhile, the politics shifted. In 2009, Barack Obama came into office and signed anexecutive order that somewhat relaxed Bushs restrictions on embryonic stem cells. Under the new rules, the federal government would fund work on new stem-cell lines, but only if they had been made from leftover embryos from fertility clinics andwith non-federal money. That compromise seemed tohelp thecontroversy settledown.

A figure of visual ability after an embryonic-stem-cell-derived treatment (red line) in patients with macular degeneration over the course of 360 days. (Schwartz et al., The Lancet, October 15, 2014)

While the controversy has calmed down, stem-cell research is taking off and scientists are making advances with both embryonic and non-embryonic cells.

Much of the initial research on stem-cell therapies has focused on eye treatments. (That's because stem-cell therapies can be unpredictable and have sometimes lead to tumors in previous experiments. A tumor in an eye would be relatively easier to deal with and remove than tumors hidden deeper inside the body.)

In October 2014, researchers from the company Advanced Cell Technology (now called Ocata Therapeutics)showed that they had created new retina cells from embryonic stem cells for 18 patients who were going blind. Afterward, 10 of them had improved eyesight. Another group of researchers in Japan is trying to do the same thing with non-embryonic cells (those aforementioned IPSCs).

10 PEOPLE WHO WERE GOING BLIND HAD Improved eyesight AFTER EMBRYONIC STEM-CELL THERAPY

Other embryonic stem-cell research has focused on developing cells that can help treat spinal-cord injuries. A company called Geron startedsafety tests in such patients in 2010.

Although a few groups are continuing to work on embryonic stem cells, many are now focusing on non-embryonic stem cells like IPSCs because they're less contentious. "Everyone jumped very, very quickly on the IPS[C] bandwagon because it was eligible for federal funding, and then also any of the controversy [regarding embryos] was dropped," says Susan Solomon, CEO of the nonprofit New York Stem Cell Foundation.

But Solomon also thinks researchers have moved away from embryonic stem cells too quickly. "We felt that it was way too early to do that," she adds. Her organization still studies embryonic stem cells, among others in part because they may be able to do things that non-embryonic stem cells can't. It's just too early to tell.

It's important to note that despite all the overhype over the years, stem-cell science has been moving at the same slow pace as most scientific fields. There are still no FDA-approved treatments that use either embryonic stem cells or IPSCs. And that means that controversy over whether embryonic stem cells are needed for science and medicine is still unresolved.

(Shutterstock)

That said, the fight over stem cells hasn't gone away forever. And there's likely to be more conflict in the future.

Even after the Obama administration relaxed the rules on funding stem-cell research, there are still plenty of hurdles. For example, federal funding is currently prohibited for research on embryonic stem-cell lines made through a technique calledSCNT or cloning, which requires creating embryos in the lab.

This technique could one day prove useful because it can turn a person's own cells into a customized embryonic stem-cell line and would therefore stop people's immune systems from rejecting stem-cell treatments.

In 2013 and 2014, two groups published the firstdemonstrations of this technique with human cells. But all such research in the US must be done with private funds.

On top of all of this, some states directly ban some or all stem-cell research within their borders no matter who's paying for it:

Note: Minnesota has a vague law on the books that's currently interpreted to mean that embryonic stem-cell research is ok. Missouri's law is a bit self-conflicting. For more details, check out The Hinxton Group's site, which includes quotations from the relevant regulations themselves.

"We went from more of a legislative vacuum to our current patchwork quilt, with legislation enacted in all of the jurisdictions where interest groups had enough clout to get the job done," Alan Regenberg, Director of Outreach and Research Support at the Johns Hopkins Berman Institute of Bioethics, told me in an email.

Several things could bring the stem-cell fight back. For example, a clinical trial could come out with some really impressive results on some sort of stem-cell treatment renewing the debate over whether regulations should be loosened. Conversely, a social conservative could run for president and bring up the ethical issues on the campaign trail. And no matter who lands in the White House in 2016, its reasonable to expect some major changes in federal policy and fast. Both George W. Bush and Barack Obama implemented their rules within the first year in office.

In 2013, Obama's stem-cell policy survived Supreme Court case Sherley v. Sebelius.

A piece on the first embryonic stem-cellmedical trials in people, by Sarah Boseley at the Guardian

Update: Clarified the current interpretation of Minnesota's stem cell laws and changed the map to match.

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Stem cells were one of the biggest controversies of 2001. Where are they now? - Vox

Human Embryonic Stem Cells (HESC) Market Analysis and Growth Forecast by Applications, Types and Competitors to … – DailyNewsKs

Human Embryonic Stem Cells (HESC) Market research report is a professional and in-depth study on the current state. The Human Embryonic Stem Cells (HESC) Industry analysis is provided for the international market including development history, competitive landscape analysis, and major regional development status.

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Next part of the Human Embryonic Stem Cells (HESC) Market sheds light on the production, production plants, their capacities, global production and revenue are studied. Also, the Human Embryonic Stem Cells (HESC) Market growth in various regions and R&D status are also covered.

Human Embryonic Stem Cells (HESC) Market report key players-Astellas Pharma Inc/ Ocata Therapeutics, STEMCELL Technologies, BIOTIME, INC, Thermo Fisher Scientific, CellGenix, ESI BIO, PromoCell, Lonza, Kite Pharma, Cynata, Sumanas, LifeCell, Geron And Many Others

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Further in the report, Human Embryonic Stem Cells (HESC) Market is examined for price, cost and gross revenue. These three points are analysed for types, companies and regions. In prolongation with this data sale price for various types, applications and region is also included.

Human Embryonic Stem Cells (HESC) Market split by Product Type-Adult Sources, Fetal Sources Human Embryonic Stem Cells (HESC) Market split by Application Regenerative Medicine, Stem Cell Biology Research, Tissue Engineering, Toxicology Testing Human Embryonic Stem Cells (HESC) Market Segment by Regions-North America, China, Europe, Southeast Asia, Japan, India

With the help of supply and consumption data, gap between these two is also explained. To provide information on competitive landscape, this report includes detailed profiles of Human Embryonic Stem Cells (HESC) Market key players.

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Marketing Strategy Analysis, Distributors/Traders: Marketing Channel, Direct Marketing, Indirect Marketing, Marketing Channel Development Trend, Market Positioning, Pricing Strategy, Brand Strategy, Target Client, Distributors/Traders List. Market Effect Factors Analysis: Technology Progress/Risk; Substitutes Threat; Technology Progress in Related Industry; Consumer Needs/Customer; reference Change; Economic/Political Environmental Change. Global Human Embryonic Stem Cells (HESC) Market Forecast 2017-2021: Global Human Embryonic Stem Cells (HESC) Capacity, Production, Revenue Forecast 2017-2021; Global Human Embryonic Stem Cells (HESC) Production, Consumption Forecast by Regions 2017-2021; Global Human Embryonic Stem Cells (HESC) Production Forecast by Type 2017-2021; Global Human Embryonic Stem Cells (HESC) Consumption Forecast by Application 2017-2021; Human Embryonic Stem Cells (HESC) Price Forecast 2017-2021.

In this Human Embryonic Stem Cells (HESC) Market analysis, traders and distributors analysis is given along with contact details. For material and equipment suppliers also, contact details are given. New investment feasibility analysis is included in the report.

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Human Embryonic Stem Cells (HESC) Market Analysis and Growth Forecast by Applications, Types and Competitors to ... - DailyNewsKs

Beta Cell Growth Finding May Lead to Improved Therapies for Diabetics – Genetic Engineering & Biotechnology News (press release)

Scientists at theUniversity of California San Diego School of Medicine usedsingle-cell RNA sequencing to map out pathways that regulate cell growth that could be exploited to trick them to regenerate.

Pancreatic cells help maintain normal blood glucose levels by producing insulin, the master regulator of energy (glucose). Impairment and the loss of cells interrupts insulin production, leading to types 1 and 2 diabetes.The team's study ("Pseudotemporal Ordering of Single Cells Reveals Metabolic Control of Postnatal Cell Proliferation") is published in Cell Metabolism.

"If we can find a drug that makes cells grow, it could improve blood sugar levels in people with diabetes," said Maike Sander, M.D., professor in the Department of Pediatrics and Cellular and Molecular Medicine at UC San Diego School of Medicine. "These people often have residual cells, but not enough to maintain normal blood glucose levels."

The body generates cells in utero and they continue to regenerate after birth. But as people age, cell regeneration diminishes. The predominant way to grow new cells is through cell division; but cells capable of dividing are rare, compromising less than 1% of all cells. Scientists have been investigating molecular pathways that govern cell growth in hopes of finding new therapies that would help people regain blood glucose control after the onset of diabetes.

In their work, Dr. Sander's team identified the pathways that are active when cells divide, providing insight into possible drug targets. The investigators were able to profile molecular features and metabolic activity of individual cells to determine how dividing cells differ from nondividing cells.

"No one has been able to do this analysis because the 1% or less of cells that are dividing are masked by the 99% percent of cells that are not dividing," said Dr. Sander. "This in-depth characterization of individual cells in different proliferative states was enabled by newer technology. It provides a better picture of what sends cells into cell division and clues we can use to try to develop drugs to stimulate certain pathways."

Whether stimulating cells to grow will result in therapeutic interventions for diabetes is still to be seen, but this new information opens the door to find out, she added.

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Beta Cell Growth Finding May Lead to Improved Therapies for Diabetics - Genetic Engineering & Biotechnology News (press release)

US Stem Cell Inc (OTCMKTS:USRM) Explodes Higher Ahead of RMAT Decision – The Oracle Dispatch

US Stem Cell Inc (OTCMKTS:USRM) is a penny player in the stem cell space that caught a massive jolt of bullish energy to start off this week. We didnt see any clear new catalyst emerge, but the move likely hooks into the companys near-term narrative, which is highly entangled with a decision of whether or not to approve the companys application to the FDA for Regenerative Medicine Advanced Therapy (RMAT) Designation for the MyoCell product as part of its MARVEL trial.

According to a press release last month, the trial had previously been placed on Inactive Status as patients were not actively being enrolled. A request was placed to the FDA to reactivate the protocol and consider the therapy for RMAT designation. We have recently heard from the FDA who has notified us that the protocol has been placed on Reactivation Status after reviewing details on the protocol and data collected on patients to date. The FDA has also notified us that they are still reviewing our submission for RMAT.

US Stem Cell Inc (OTCMKTS:USRM) bills itself as a company committed to the development of effective cell technologies to treat a variety of diseases and injuries. By harnessing the bodys own healing potential, we may be able to reverse damaged tissue to normal function.

U.S. Stem Cells discoveries include multiple cell therapies in various stages of development that repair damaged tissues throughout the body due to injury or disease so that patients may return to a normal lifestyle.

USRM is focused on regenerative medicine. While most stem cell companies use one particular cell type to treat a variety of diseases, U.S Stem Cell utilizes various cell types to treat different diseases. It is our belief that the unique qualities within the various cell types make them more advantageous to treat a particular disease.

According to company materials, US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.

Subscribe below and well keep you on top of whats happening before $USRM stock makes its next move.

As noted above, the stock shifted into bull mode to start this week. However, traders are scrambling to uncover the catalyst for the move.

We would say the most likely catalyst has to do with expectations surrounding its application for RMAT status with the FDA. That was apparently expected to hit as a decision sometime in May. Today marks the outset of the new month, and we may have either rumors or speculation fueling the idea that one must not wait any longer if one wants to catch the action into that catalyst the idea being, approval would seriously juice this stock higher.

Recent action has seen 33% piled on for shareholders of the company during the trailing week. This is emblematic of the stock. USRM has evidenced sudden upward volatility on many prior occasions. Whats more, the listing has benefitted from a jump in recent trading volume to the tune of 16% over what the stock has registered over the longer term.

According to the company, Thanks to the REGROW component of the Cures Act, the FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. We believe that our MyoCell product meets these requirements, as we have demonstrated clinical efficacy in both preclinical and clinical studies, including our most recent MARVEL trial publication.

Earning a current market cap value of $44.2M, USRM has a reported chunk ($271K) of cash on the books, which compares with about $3M in total current liabilities. USRM is pulling in trailing 12-month revenues of $3.1M. In addition, the company is seeing major top line growth, with y/y quarterly revenues growing at 66.6%. We will update the story again soon as developments transpire. For continuing coverage on shares of $USRM stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!

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US Stem Cell Inc (OTCMKTS:USRM) Explodes Higher Ahead of RMAT Decision - The Oracle Dispatch

Presidential Symposium at the American Society of Gene and Cell … – Yahoo Finance

FREMONT, Calif., May 3, 2017 /PRNewswire/ --Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced that data from its AST-OPC1 clinical program for severe cervical spinal cord injury will be presented during the Presidential Symposium at the American Society of Gene and Cell Therapy (ASGCT) 20th Annual Meeting, being held in Washington, D.C. during May 10-13, 2017.

"The ASGCT decision to include a presentation on AST-OPC1 in its Presidential Symposium signifies the ground-breaking nature of our program, and reflects the encouraging efficacy and safety data we have seen to date in patients with severe spinal cord injuries that have been treated with AST-OPC1," said Steve Cartt, President and Chief Executive Officer of Asterias. "Data will be presented from our SCiStar study demonstrating the potential of AST-OPC1 to help patients with complete paralysis regain increased arm, hand and finger function, and thus greater ability to live independently."

Jane S. Lebkowski, Ph.D., Asterias' President of R&D and Chief Scientific Officer, will be one of the presenters during the Presidential Symposium session scheduled on Friday, May 12, 2017 at 1:00pm Eastern Time. Dr. Lebkowski's presentation, titled "498 - Safety and Efficacy of Human Embryonic Stem Cell Derived Oligodendrocyte Progenitor Cells (AST-OPC1) in Patients with Subacute Cervical Spinal Cord Injury," is expected to begin at 2:15pm Eastern Time. The abstract for Dr. Lebkowski's presentation at the ASGCT meeting is available online at: http://www.abstractsonline.com/pp8/#!/4399/presentation/1996.

ASGCT is the primary professional membership organization for gene and cell therapy. The Society's members are scientists, physicians, patient advocates, and other professionals. Its members work in a wide range of settings including universities, hospitals, government agencies, foundations, biotechnology and pharmaceutical companies. Its mission is to advance knowledge, awareness, and education leading to the discovery and clinical application of gene and cell therapies to alleviate human disease.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at http://www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

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In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with AST-OPC1. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries, which represents the first targeted population for registration trials.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at http://www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias' filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

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