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CMBG Receives US$2.29 Million Grant For Stem Cell Therapy – Asian Scientist Magazine

Chinas Cellular Biomedicine Group has received US$2.29 million to support pre-clinical studies of stem cell therapy for knee osteoarthritis.

Asian Scientist Newsroom | March 9, 2017 | Pharma

AsianScientist (Mar. 9, 2017) - Cellular Biomedicine Group Inc., a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, has been awarded US$2.29 million by the governing Board of the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoin, CBMGs Off-the-Shelf allogeneic human adipose-derived mesenchymal stem cells for the treatment of knee osteoarthritis in the United States.

While CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell acute lymphoblastic leukemia (ALL) and refractory diffuse large B-cell lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoin in knee osteoarthritis, this latest announcement represents CBMGs initial entrance into the United States for its off-the-shelf allogeneic stem cell candidate AlloJoin.

The US$2.29 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. After the award, CIRM will be a more active partner with its recipients to further increase the likelihood of clinical success and help advance a pre-clinical applicants research along a funding pipeline towards clinical trials.

CBMGs knee osteoarthritis pre-clinical program is considered late-stage, and therefore it meets CIRM 2.0s intent to accelerate support for clinical stage development for identified candidates of stem cell treatments that demonstrate scientific excellence.

We are deeply appreciative to CIRM for their support and validation of the therapeutic potential of our knee osteoarthritis therapy, said Mr. Tony (Bizuo) Liu, Chief Executive Officer of CBMG. The CIRM grant is the first step in bringing our allogeneic human adipose-derived mesenchymal stem cell treatment for knee osteoarthritis (AlloJoin) to the U.S. market.

In order to demonstrate comparability with cell banks previously produced in China for our U.S. IND filing, we are addressing the pre-clinical answers required for the FDA. With the funds provided by CIRM, we will replicate and validate the manufacturing process and control system at the cGMP facility located at Childrens Hospital Los Angeles to support the filing of an IND with the FDA.

CBMG recently announced promising interim three-month safety data from its Phase I clinical trial in China for AlloJoin, its off-the-shelf allogeneic stem cell therapy for knee osteoarthritis. The trial is on schedule to be completed by the third quarter of 2017.

Source: Cellular Biomedicine Group Inc; Photo: Shutterstock. Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.

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CMBG Receives US$2.29 Million Grant For Stem Cell Therapy - Asian Scientist Magazine

Mountain News: Clinic advances stem-cell research | Mountain … – Pique Newsmagazine

VAIL, Colo. In 1988, George Gillett, who then owned what has become Vail Resorts, persuaded Dr. Richard Steadman to relocate his medical practice from Lake Tahoe to Vail. The Steadman Clinic soon became the go-to-place for athletes with knee and other joint problems.

It still is. Football quarterback Tom Brady has been there, soccer icon Pele and basketball power Yao Ming. Plus John Elway, Mario Lemieux, and Alex Rodriguez. Big names from the ski world, obviously. But also the drummer for the rock band U2, Larry Mullen, Jr.

Now, the clinic will be getting a new, 2,415-square-metre research lab courtesy of the Vail Valley Medical Center. The US$68 million facility will house the Steadman Philippon Research Institute's labs for surgical skills, robotics, regenerative medicine, and bio-motion. The clinic and associated research institute together employ 190 people.

Research being conducted there is getting attention. A recent report in The Denver Post by staff writer John Meyer suggests you may have a stake in the work at the base of Vail Mountain. The story focused on the work of Dr. Johnny Huard, the chief scientific officer and director of the Center for Regenerative Sports Medicine.

Huard is trying to advance the techniques that allow people to heal more rapidly. The field is called biologics. Cells from the patient's own body are used in concentrated injections to hasten repair of tissue at the site of the injury.

Stem cells and platelet-rich plasma therapy will someday delay age-related diseases and cut the recovery time from serious injuries.

"I don't think we can reverse aging, but I think we can age better and recover from injury better," said Dr. Marc Philippon, managing partner of the Steadman Clinic.

"As a surgeon, my biggest challenge is, if I cut on you there's always that healing phase. We want you to recover faster. But the most important thing is prevention of injury. If your cells are aging better, you'll have less injury."

Before moving to Vail two years ago, Huard directed the Stem Cell Research Center at the University of Pittsburgh. In Vail, the researchers think injections of stem cells and PRP can help delay or prevent the need for joint replacements. At the adjacent Steadman Clinic, they can test the theories in clinical trials. Animal studies have already shown that young stem cells can rejuvenate old stem cells.

Huard advocates passionately harvesting stem cells from the umbilical cord of a newborn, freezing them at -80 degrees Fahrenheit (-62 C). Those cells can later be thawed and reintroduced into the body as younger and more robust stem cells than the ones that have aged in the patient.

An athlete who blows out an anterior cruciate ligament in training camp currently loses a full year. Being able to return to play sooner could dramatically change the recovery time for injuries.

As good as dead, skier survives a heart attack

JACKSON, Wyo. Imagine having a heart-attack in the backcountry. Just what do you think your odds are?

Mike Connolly, 61, was skiing on a ridge of Maverick Peak, in Grand Teton National Park, when he reported chest pains. Because they had cell phones, members of his party were able to summon help. A helicopter with three members of the Teton County Search and Rescue was dispatched.

At the scene, Connolly went into cardiac arrest. He ceased breathing and he had no pulse. Members of his group began cardiopulmonary resuscitation. Then rescuers arrived with an automated defibrillator. They shocked Connolly once, and he regained a pulse and began breathing again. A short time later, he was able to verbally communicate with those around him.

Uber drivers now ply roads

JACKSON, Wyo. Because of new state legislation, Uber and Lyft are now allowed to operate in Wyoming. Uber took just hours after the bill was signed before opening its car doors for business in Jackson Hole, reported the News&Guide.

Uber drivers must have valid licences, registration, proof of insurance, and a passing grade on an online safety screening. Uber allows drivers to use their own cars or commercially licensed vehicles.

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Mountain News: Clinic advances stem-cell research | Mountain ... - Pique Newsmagazine

Kansas Stem Cell Center Close To First Clinical Trial – KCUR

An adult stem cell center established by the Kansas Legislature in 2013 is almost ready for its first clinical trial.

Buddhadeb Dawn, executive director of the Midwest Stem Cell Therapy Center, told legislators Tuesday that the trial will focus on treating graft-versus-host disease and will begin after final approvals from the U.S. Food and Drug Administration.

Our goal was to do this (trial) in January, but we got delayed because of different things, Dawn said during a hearing of the House Health and Human Services Committee. So we are now hoping to start it perhaps in summer.

Based at the University of Kansas Medical Center in Kansas City, the stem cell center has analyzed trials done elsewhere and hosted a clinical trial sponsored by a biotech company that uses modified stem cells from bone marrow to treat stroke.

But the graft-versus-host disease trial would be the first homegrown one.

Download the Midwest Stem Cell Therapy Center annual update to legislators.

Graft-versus-host disease is a potential complication when a patient receives a transplant of tissue, like an organ or bone marrow, from another person.

The disease occurs when transplanted tissue fights the patients natural immune system, potentially damaging the liver, skin or other areas. Its a rare illness, with about 20,000 cases in the United States each year.

Rep. Randy Powell, a Republican from Olathe, said the trial was a welcome and exciting development. He said his wife is at risk for the illness following treatment for leukemia.

I know that graft-versus-host is a big thing, Powell said. I think my wife still has an annual checkup where they keep their eye out (to make sure) thats not sticking its head up and causing issues.

Dawn said the center would like to take the next step and move into clinical trials using adult stem cells to treat things like joint ailments, diabetes and amyotrophic lateral sclerosis, also known as Lou Gehrigs disease.

But the regulatory process takes time.

Wed like to be able to offer a portfolio of different disease conditions that adult stem cells can benefit, Dawn said. Im hoping that within the next five years we would at least have some FDA approval for treatment with adult stem cells for other conditions.

Dawn said successful trials could lead to more private investment dollars so we are self-sustaining at some point in the future.

The centers reliance on state funds has been a point of contention for fiscally conservative legislators in the past. Most of the facilitys budget still comes from the states payment, which was reduced by about $28,000 to $754,500 last year.

Were maximizing every opportunity we can with what we have right now.

Thats far less than what stem cell research facilities in other states receive.

Doug Girod, executive vice president of the KU medical center, said that given the budget, Dawn and his small team have done remarkable work.

We could be 10 times bigger than we are and doing 10 times as much if we had the resources, Girod said. But I think were maximizing every opportunity we can with what we have right now.

The center was spearheaded by socially conservative legislators, including Sen. Mary Pilcher-Cook, to showcase adult stem cell research as an alternative to using stem cells derived from human embryos.

About $56,000 of its annual budget goes to educating the public about the differences between embryonic stem cells and adult cells and hosting an annual conference about advances in adult stem cell treatment.

Rep. John Wilson, a Democrat from Lawrence, said he initially was skeptical about the facility because he thought the Legislature was inserting itself into a religious or philosophical fight. But he said his attitude has changed.

Im glad that despite my opposition to it the state has gone forward with funding some really terrific research, Wilson said. My concern now is how do we take it to the next level so all of this hasnt been for nothing.

Andy Marso is a reporter for the Kansas News Service, a collaboration of KCUR, Kansas Public Radio and KMUW covering health, education and politics in Kansas. You can reach him on Twitter@andymarso. Kansas News Service stories and photos may be republished at no cost with proper attribution and a link back to kcur.org.

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Kansas Stem Cell Center Close To First Clinical Trial - KCUR

Spokane woman willing to fight rare disease to the end – MyNorthwest.com

Cat Davis' body is hardening on the inside and outside due to a disease called Scleroderma. (Cat Davis)

There are walks, runs, auctions and GoFundMes for every cause under the sun, and theyre all vying for your money. That, perhaps, makes it even more difficult to get people to pay attention to Scleroderma, a disease that hardens organs to the texture of leather and has no cure.

But there is Cat Davis.

I met Cat four years ago while working for KXLY TV in Spokane when the first attempt to save her life launched. The first thing you notice about Cat isnt her disease its her smile. A big, toothy smile that stretches from ear to ear. She beams despite her seven-year battle with Scleroderma.

Sclero means hard and derma means skin. Its a very literal translation.

If somebody touches their hand, for instance, the top of your skin, that skin moves. Mine doesnt. Thats how tight it is. My fingers are not straight, they are curled because the skin is pulling so tight. Basically, my body mass produces collagen so my skin is almost leather-like, Cat explained.

Her body is slowly hardening on the outside and on the inside.

My esophagus is completely paralyzed from it and also most of my digestive system is paralyzed, Cat said.

She was diagnosed when she was 22, and with no cure in sight, she isnt sure shell live much longer. That isnt because she hasnt tried.

Four years ago, Cat launched a successful campaign to raise enough money for a procedure doctors believed would save her life. The Spokane community together raised $150,000 for the stem-cell transplant of her own stem cells.

It worked, but only for the first two years. She relapsed.

My skin started tightening again, skin started curling, I was really devastated. After the first transplant, I saw positive things from it, but I never was super well if that makes sense. I would watch other people who had done the transplant and kind of been following their stories and they were back to work and that was never me, Cat said.

She was devastated but never deterred, despite losing her father to Alzheimers Disease just three months ago and her family losing their home of 30 years under crippling medical bills.

Cat has never lost her hope or her sense of mission. This time, she says, its not about saving just her life.

Ive had some of my closest friends die from Scleroderma over the last couple of years, and that is why I do what I do. I do it for them. I do it for myself. I do it for everyone out there with Scleroderma who doesnt have a voice. For the unheard. For the too sick to speak out. I am fighting for everyone, Cat said.

Her mission is why shes willing to be what she calls the guinea pig for another procedure a stem-cell transplant from a Scleroderma-free, perfect match. That would be her brother.

No one with her condition has ever had both stem-cell procedures. She had to convince a doctor to be the first.

Im pretty convincing. I know what I want. He was iffy at first and I just was like you have to meet me, you have to see that I am strong and I want this and I can fight. I just need you on my team. And we met and afterward he was like, Im on board, Cat said.

So, CureforCat.com has launched again with everyone she loves giving you every reason you need to support this one cause. a video on the homepage features her mother, her brothers, friends and community members who believe in her mission to fight for everyone suffering from this rare disease.

Every day I wake up and something is different. Ive lost another thing that I can do. and because we dont know whats going to happen with the transplant whats going to be reversed, whats not we need it now. We dont need it in six months or a year. I wont even be alive in a year. Thats how sick I am. So its an urgent thing and I need the money ASAP, Cat said.

She needs $500,000 for the stem-cell transplant alone. Like last time, in addition to her disease, Cat has also been battling Medicare. Scleroderma is not on their pre-approved list. Shes had six of her doctors write letters on her behalf, but still no insurance coverage.

If shes able to successfully raise the money for the procedure, shell stay down in Los Angeles for recovery and care. The risks include graft vs host disease which gives her only a 50 percent chance of survival.

Whether this transplant works or not at least I will have fought all the way until the end, Cat said.

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Spokane woman willing to fight rare disease to the end - MyNorthwest.com

This University of Nevada Student Proved Doctors Wrong About MS – Study Breaks

Multiple sclerosis left Alexa Silvers legally disabled at sixteen, but an unpublicized treatment option completely cured her.

By Tylah Silva, Emerson College

Alexa Silvers is a college student, survivor and an all-around amazing human being.

The biggest obstacles most of us had to face at sixteen were hormonal acne and a bad breakup. Silvers had to deal with multiple sclerosis. The autoimmune disease known as M.S. attacked her legs and put her in wheelchair. The doctors told Silvers that treatments could help, but that ultimately her condition was permanent.

They were wrong.

Through it all, Silvers kept a faithful mind, putting her efforts into her treatment and researching a cure. Then, she stumbled upon stem cell research. With the help of her mother, many charitable donators and a staff of skillful doctors, Silvers was cured after having M.S. for four years.

Now, this University of Nevada at Reno student is making an effort to get the word out on stem cell treatments.

Tylah Silva: What was it like being diagnosed with M.S. at 16?

Alexa Silvers: It was completely life changing. I suddenly felt like an outcast, and felt like I was dealing with an issue that even my closest friends didnt completely get. I kept it a secret as best I could, but as my condition worsened, it became harder and harder to hide.

UN student Alexa Silvers

TS: Had you ever heard about M.S. before you were diagnosed?

AS: I had never heard of it until I started experiencing weird symptoms. Every Google search led me to undeniable M.S. When I brought the possibility up to my physician, she actually laughed and told me it was impossible for someone my age to have a disease like M.S.

TS: Were you frightened by your diagnosis?

AS: I was terrified. The scariest part of multiple sclerosis is its unpredictability. I was already legally disabled at 16, and I had no idea if I would wake up one day not able to walk suddenly. It was a constant struggle, countless failed medications, neurologists telling me that patients with images like mine should already be in a wheelchair, and that every day I wasnt I should be cherishing.

TS: What methods did you use to cope with your ailment?

AS: I am very strong in my faith. I notice that some people, when faced with adversity, tend to adopt a victim mentality and distance themselves from church and all support, but I made a conscious choice to do the opposite. I surrounded myself with people who helped me stay hopeful even when things werent looking great.

TS: How did your family and friends react?

AS: My family and closest friends were amazing, I did not want to be treated differently, and they were really great about making sure things still felt normal. Although, I think a lot of people didnt really understand, and to this day still dont. It was a lot of but you look fine.

TS: How did you stumble upon the stem cell research?

AS: I was running out of options as far as common M.S. treatments go. I had just relapsed on my third therapy, and decided there had to be a better option than a medication that only slows disability progression down 40 percent of the time. I watched M.S. news articles closely, and one day came across an article on a stem cell treatment that was successfully halting M.S. in England.

I immediately began searching on clinicaltrials.gov for a similar study in the U.S. I found one that Dr. Richard Burt had been conducting in Chicago for over 10 years. It had almost a 90 percent success rate in stopping disease progression. I just remember thinking, this has been happening since before I was born, and none of the many neurologists I have seen have even thought to mention it. This is a government trial with results posted in JAMA, and theres no way they havent heard of it. It really is a disservice to autoimmune patients worldwide.

TS: Have you heard any other stem cell success stories that have inspired you?

AS: Hundreds! I met so many other patients, even in just the two months I was in Chicago for my transplant. It is the most effective treatment for autoimmune disease, and it is saving lives.

TS: Do you have any thoughts about the future of U.S. healthcare as someone who is affected so personally by it?

AS: This experience has been very eye opening to where this countrys healthcare priorities lay. The fact is, a cure for autoimmune disease takes money away from big pharma. With all the successful trials already conducted with HSCT, statistically there is no logical reason it is not yet approved for treatment of MS. Stem cells have so much potential for future use; I have even seen ALS being treated with a similar protocol in the news very recently.

TS: I saw your Go Fund Me page that hit over its $115,000 goal. What was it like to get that kind of support?

AS: I never expected that level of support. It just went viral overnight. I remember the amount was stagnant for weeks, and one morning I woke up and it was over eighty thousand. Every time I refreshed the page it went up even higher.

I was crying all day, I couldnt believe this was all happening so quickly.

For the first time in years, I felt without a doubt that everything was going to turn out okay.

TS: What is like being M.S. free after so long?

AS: Its very surreal. I dont think Ill even completely believe it until I get my repeat images. Its crazy trying to comprehend that this is it. I notice improvements all the time; for example, I used to have to hug the rail on stairs and slowly guide myself down, and now I fly down hands free most days, not even thinking about it. I feel like I have my life back, and its the biggest blessing I have ever received.

TS: What is your relationship with your body now?

AS: I feel much more confident. Looking back at what I was able to get through reminds me not to sweat the little stuff. Being diagnosed with a chronic debilitating illness at 16 and completing an intense stem cell transplant three years later is not a small feat. I try to remember all I was able to accomplish.

I have lingering fears of course. This treatment doesnt heal existing nerve damage immediately, so I still have days where my symptoms resurface. I have to remember not get discouraged by the bad days; recovery is a roller coaster.

TS: What are you hoping for by getting your story out?

AS: I am hoping that this story can get to as many people as possible. Millions are affected by autoimmune disease or know someone who is, and if one person pursues a stem cell transplant after hearing my story, that makes it all worthwhile.

TS: What do you want people to know about MS or stem cell research?

AS: I want to make sure people know that if you choose to pursue a stem cell transplant, it may well be one of the hardest things you ever have to go through. At times it will be scary; you may feel weaker than you ever have and you may question your ability to cross the finish line, but a lifetime with an unpredictable chronic illness is much more terrifying. This is the best treatment out there. It gives second chances and a newfound appreciation for what it means to be in good health.

TS: Whats your next step?

AS: I will be returning to Chicago periodically for the next 5 years to get follow-up imaging. These MRIs will confirm my M.S. is in permanent remission. In the meantime, I am back at school pursuing a degree in Nutrition and Dietetics. I plan to take my life back and live it to the fullest. Never take your good health for granted, it is one of the greatest gifts you could ever receive.

Alexa SilversM.S.multiple sclerosis

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This University of Nevada Student Proved Doctors Wrong About MS - Study Breaks

French doctors offer hope to people with sickle cell disease with a successful DNA reversal treatment on a teenager – Ventures Africa

Thanks to the constant advancement of Science, a cure may have been discovered for sickle cell disease. Doctors in Paris have monitored and confirmed the success of a DNA reversal treatment carried out on a teenager 15 months ago. Since the disease is such that the bone marrow produces deformed red blood cells, scientists altered the genetic instructions in his bone marrow, so it produced healthy red blood cells.

James Gallagher for BBC reports that the teenager had his bone marrow taken out, stem cells harvested and genetically altered with a virus to infect it with correct instructions. Next, he underwent chemotherapy for four days to eliminate his diseased stem cells, before the corrected bone marrow was replanted. Since then, the teenager has received a clean bill of health. So far the patient has no sign of the disease, no pain, no hospitalisation We are quite pleased with that, Philippe Leboulch, a professor of medicine at the University of Paris, told the BBC.

Prior to the surgery, the condition of the teenager is said to have been critical. So much that he needed to have his spleen removed and his hips replaced. He also used to have a monthly blood transfusion to dilute his defective blood. But now, he no longer requires a transfusion.

Although Professor Leboulch is hesitant about asserting the treatment as a cure for sickle cell anaemia, the success of the pilot case is a significant milestone in the treatment of the disease. According to the professor, there needs to be more performance of this therapy on several patients to create a certainty that it is robust enough to propose it as a mainstream therapy.

However, just as the bone marrow transplant, the only known cure for sickle cell anaemia is expensive, this pioneering treatment is quite costly and can only be performed in highly advanced hospitals. This already poses a huge challenge to the African continent where the disease is predominant, as the cost implications are bound to widen between developed and developing countries, largely due to exchange rates.

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French doctors offer hope to people with sickle cell disease with a successful DNA reversal treatment on a teenager - Ventures Africa

Creative Medical Technology Holdings Appoints Internationally Renowned Stem Cell Pioneer as Chief Scientific Officer – Yahoo Finance

SAN DIEGO and PHOENIX, March 8, 2017 /PRNewswire/ --Creative Medical Technology Holdings, Inc. (CELZ) announced today the appointment of Dr. Thomas Ichim to the position of Chief Scientific Officer. Dr. Ichim will lead development of the Company's clinical stage CaverStemTM personalized stem cell therapy for erectile dysfunction, as well as advance preclinical and eventually clinical studies on the Company's universal donor AmnioStemTM stem cell therapy for post-stroke recovery.

"It is my honor to welcome Dr. Ichim to the position of Chief Scientific Officer," said Timothy Warbington, President and CEO of CELZ. "I have known Dr. Ichim for more than 10 years and have witnessed him grow his previous company, Medistem Inc., from concept to FDA Investigational New Drug (IND) clearance, to eventual acquisition by the NYSE traded company Intrexon. I am confident that Dr. Ichim will put CELZ on the same trajectory of success."

"Having published 20 peer-reviewed papers with Dr. Ichim over the last nine years, I greatly respect his unique ability to rapidly accelerate progress from concept, to patent, product. I look forward to continuing our collaborations in his new position," said Dr. Amit Patel, Cofounder and Board Member of CELZ, and Head of Cardiac Surgery at University of Miami.

"Dr. Ichim represents a true visionary in the area of cellular therapy, being one of the few people that effectively combines deep knowledge of basic science, regulatory affairs, and clinical translation. I plan to leverage our existing strengths at the Pacific Neurosciences Institute and at St John Providence to accelerate neurological uses of the Company's AmnioStemTM stem cell, particularly in the indication of post-stroke recovery," said Dr. Santosh Kesari, MD, PhD, FANA, FAAN, Scientific Advisory Board Member of CELZ. Dr. Kesari is Chair and Professor, Department of Translational Neurosciences and Neurotherapeutics, John Wayne Cancer Institute, as well as Director of Neuro-oncology, Providence Saint John's Health Center and leads the Pacific Neuroscience Research Center at Pacific Neuroscience Institute.

"I am enthusiastic about working with the distinguished team that Mr. Warbington assembled to accelerate clinical development of the Company's products," said Dr. Thomas Ichim, Ph.D. "This is one of those few occasions when one finds themselves in a position to work with people that one respects both as individuals and as leaders in their fields."

Dr. Ichim has extensive experience with stem cell therapy and cellular product development through FDA regulatory pathways. Dr. Ichim spent over seven years as the Chief Executive Officer, and subsequently, President and Chief Scientific Officer of Medistem, developing and commercializing a novel stem cell, the Endometrial Regenerative Cell, through drug discovery, optimization, preclinical testing, IND filing, and up through Phase II clinical trials with the FDA. Subsequent to the acquisition of Medistem by Intrexon, in a deal worth $26 million, Dr. Ichim was brought on to the parent company in its cell engineering unit as Vice President of Cellular Therapy. Dr. Ichim has over 100 patents and patent applications, as well as 103 peer reviewed publication.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a clinical stage biotechnology company currently trading on the OTCQB under the ticker symbol CELZ. For further information about the company go to http://www.creativemedicaltechnology.com.

Forward-Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at http://www.sec.gov.

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Creative Medical Technology Holdings Appoints Internationally Renowned Stem Cell Pioneer as Chief Scientific Officer - Yahoo Finance

Radiation study points to leukemia risk for Mars explorers – New Atlas

2 pictures

The Martian environment is not too damaging to NASA's Curiosity Mars rover, but that won't be the case for one-day settlers on the Red Planet(Credit: NASA/JPL-Caltech/MSSS)

The prospect of a manned mission to Mars raises all kinds of uncertainties, including how the explorers will feed themselves and find shelter, assuming that they make it there in the first place. But one of the real reservations scientists currently hold about travel to the Red Planet is what kind of impact deep-space radiation might have on the human body. In a new NASA-funded study, researchers have found that it may heighten the risk of leukemia in humans, brought on by changes to the health and function of vital stem cells.

The question of how radiation affects humans in space is being addressed from a number of angles, with NASA conducting studies into its impacts on spacewalking astronauts, how it might affect cognition and behavior and how it might switch genes on and off. One source of radiation is galactic cosmic rays (GCRs), which predominantly travel from outside our solar system, while a closer source is our own Sun, which shoots off solar flares and energy in the form of electromagnetic waves and particles.

Here on Earth we are guarded from these dangers by our planet's magnetic field, but in space and on Mars whose magnetic field disappeared billions of years ago we'll receive no such protections. This week, NASA even floated the idea of one day creating an artificial magnetic field around Mars to protect crewed missions there in the future.

Research into the effects of deep-space radiation will help scientists determine how necessary such extreme measures might be. In the latest example of this, a team from Wake Forest Baptist Medical Center carried out a study looking to assess its impacts specifically on human hematopoietic stem cells (HSCs). These immature cells can develop into all types of blood cells, including those that fight infections and malignant cells, and have shown promise as tools in the fight against HIV and leukemia.

The team did this by taking HSCs from healthy donors aged between 30 and 55 (to represent typical astronauts) and exposed them to simulated solar energetic particles and GCRs at the same levels one is expected to experience during a Mars mission. Analysis of the cells in the lab afterwards revealed that the radiation affected the cells at the stem cell level, causing mutations in genes that affected their ability to develop into mature blood cells.

"Radiation exposure at these levels was highly deleterious to HSC function, reducing their ability to produce almost all types of blood cells, often by 60 to 80 percent," says Christopher Porada, senior researcher on the project. "This could translate into a severely weakened immune system and anemia during prolonged missions in deep space."

Studying the radiation-treated cells in the lab is one thing, studying them in the body is another. To get an insight into what that might look like, the team then transplanted the GCR-irradiated HSCs into mice in effect, "humanizing" them. The mice went on to develop T-cell acute lymphoblastic leukemia. The team describe this as the first demonstration that deep space radiation may increase the leukemia risk in humans.

"Our results show radiation exposure could potentially increase the risk of leukemia in two ways," says Porada. "We found that genetic damage to HSCs directly led to leukemia. Secondly, radiation also altered the ability of HSCs to generate T and B cells, types of white blood cells involved in fighting foreign 'invaders' like infections or tumor cells. This may reduce the ability of the astronaut's immune system to eliminate malignant cells that arise as a result of radiation-induced mutations."

The research was published in the journal Leukemia.

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Radiation study points to leukemia risk for Mars explorers - New Atlas

Center for Stem Cell & Regenerative Medicine – Institute for …

Phone 713.500.3429; Fax 713.500.2424

About the Center

A major focus of contemporary medicine is the development of effective therapies for the restoration of human tissues and organs lost to diseases and trauma. Regenerative Medicine is a rapidly emerging field that stands at the intersection of a variety of rapidly developing scientific disciplines: stem cell biology, tissue engineering, biomaterials, molecular biology, immunology and transplantation biology and clinical research. Implicit in the successful design, implementation and application of regenerative medicine/tissue engineering approaches to the repair of a damaged tissue or organ is the reliance on the unique biological properties of stem cells.

The mission statement of the Center for Stem Cell and Regenerative Medicine at the IMM is: To study the fundamental properties of stem cells and to translate their unique biological properties into novel cellular therapies for graft engineering and tissue regeneration for currently intractable disorders. While it is therefore implicit that any such program would span basic-translational-clinical research, it is essential that such an endeavour is ultimately underpinned by excellence in fundamental stem cell research. The Director of the Center, Dr. Brian R. Davis is currently in the process of recruiting a multidisciplinary faculty with the appropriate breadth of expertise, innovation and scientific rigor in the discipline of stem cell biology with the dual intention to promote the excellence and innovation of research within the Center and secondly to ensure the quality and appropriateness of stem cell based translational research initiatives emanating from the Center. In addition, the Center is also envisioned as an educational resource, which in the medium to long-term will be the basis for the development of an academic program in stem cell biology on campus. Moreover, by interfacing effectively with other programs and institutions within the UTHSC, the Center will also act as a focus to stimulate the development and implementation of novel cellular therapies for a range of diseases and disorders.

Some of the current areas of research in the Center are highlighted below:

Brian R. Davis, Ph.D. Associate Professor of Molecular Medicine & Director, Center for Stem Cell and Regenerative Medicine Annie and Bob Graham Distinguished Chair in Stem Cell Biology Ph.D. ~ California Institute of Technology / Pasadena, California

Qi Lin Cao,M.D. Associate Professor, The Vivian L. Smith Department of Neurosurgery & Center for Stem Cell and Regenerative Medicine M.D.~ Hunan Medical University / Hunan, China

Charles S. Cox, Jr.,M.D. Professor, Department of Pediatric Surgery& Center for Stem Cell and Regenerative Medicine M.D.~ The University of Texas Medical Branch / Galveston, Texas

Radbod Darabi, M.D., Ph.D. Assistant Professor of Stem Cell Biology, Center for Stem Cell and Regenerative Medicine M.D.- Zahedan University of Medical Sciences/ Zahedan, Iran Ph.D.- Tehran (Iran) University of Medical Sciences/ Tehran, Iran

Dong H. Kim,M.D. Professor,Chair, The Vivian L. Smith Department of Neurosurgery&Center for Stem Cell and Regenerative Medicine M.D.~ The Univeristy of California, San Francisco / San Francisco, California

Mikhail G. Kolonin,Ph.D. Associate Professor of Molecular Medicine,Center for Stem Cell and Regenerative Medicine Jerold B. Katz Distinguished Professorship in Stem Cell Research Ph.D.~ Wayne State University / Detroit, Michigan

Yong Li, M.D.,PhD Associate Professor, Department of Pediatric Surgery & Center for Stem Cell and Regenerative Medicine M.D.- Second Military Medical University / People's Republic ofChina Ph.D.- Third Miliary Medical University / People's Republic of China

Ying Liu, M.D.,Ph.D. Assistant Professor, The Vivian L. Smith Department of Neurosurgery & Center for Stem Cell and Regenerative Medicine M.D.- Peking University Health Science Center / Beijing, China Ph.D.- University of Utah / Salt Lake City, Utah

Nami McCarty,Ph.D. Associate Professor,Center for Stem Cell and Regenerative Medicine Ph.D.- Purdue University / West Lafayette, Indiana

Naoki Nakayama,Ph.D. Associate Professor of Molecular Medicine,Center for Stem Cell and Regenerative Medicine Ph.D.- University of Tokyo / Tokyo, Japan

Laura A. Smith Callahan,Ph.D. Associate Professor of Molecular Medicine,Center for Stem Cell and Regenerative Medicine Ph.D.- University of Michigan / Ann Arbor, Michigan

Pamela L. Wenzel, PhD Assistant Professor, Department of Pediatric Surgery & Center for Stem Cell and Regenerative Medicine PhD- The Ohio State University / Columbus, Ohio

Jiaqian Wu, PhD Assistant Professor, The Vivian L. Smith Department of Neurosurgery & Center for Stem Cell and Regenerative Medicine PhD- Baylor College of Medicine / Houston, Texas

Wa Xian, PhD Assistant Professor of Molecular Medicine, Center for Stem Cell and Regenerative Medicine PhD- The University of Texas, M. D. Anderson/ Houston, Texas

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Regenerative therapy is new frontier in injury recovery – TCPalm

Fran Foster, The Newsweekly 1:01 a.m. ET March 8, 2017

Regenerative Biologics Institute (RBI) Managing Director Jason Griffeth in the procedure room where he performs advanced regenerative medicine treatments. He has been studying the science of stem cells for nearly 20 years.(Photo: Fran Foster)

Whenever their bodies are ailing, people usually look for a magical solution or an easy-to-swallow pill to make things better. Turns out, in some situations, that sought-for remedy may be in your own fat cells.

Beth Darraugh, 50, lives here in Vero Beach as well as in New York City. She has been active all of her life from volleyball in her youth to walking along the beach in Mexico. Shes experienced plenty of aches and pains but, as she has gotten older, she realized she wasnt recovering as quickly.

I had already had some orthopedic problems with my knee and was told I was probably going to have to succumb to surgery, she says. I wasnt ready for that and started researching about other techniques. While in Mexico, walking with my mom, something didnt feel right and I knew I had to do something. (Living) part time in New York City requires a lot of walking and it was getting harder and harder.

This is where Regenerative Biologics Institute, located here in Vero Beach, entered Darraughs life. RBI provides an option for treating orthopedic conditions and pain besides pills, cortisone shots, arthroscopic surgery or total joint replacements, which can all have significant drawbacks.

Many people are not aware that they can harness and concentrate their own bodys natural healing ability in the form of stem cells and platelets, said RBI Managing Director Jason Griffeth. There are safe and effective options that are treating these conditions through regenerative medicine.

Basically stem cells are the bodys natural repair cells, from which all other cells are derived. According to multiple research sources, stem cells can regenerate and heal injured tissue, as well as decrease inflammation. As we age, the amount of stem cells in our body declines as does our bodys ability to repair an injury.

RBIs Managing Director Jason Griffeth with Medical Director Dr. Brett Haake at their office across from Indian River Medical Center in Vero Beach(Photo: Fran Foster)

We found out that fat tissue is one of the richest sources of stem cell in the body and it works really well to unlock our bodies as a natural way of healing itself, Griffeth said, joking that Its not that bad to carry around a little extra fat.

The science behind it has been around since 1981 but has received more attention since money started pouring into the research. Professional athletes such as Mets pitcher Bartolo Colon and tennis star Rafael Nadal have reportedly used regenerative therapy to speed up injury recovery time.

In 2013, Harvard Medical School received a 10-year, multimillion grant from the National Football League Players Association for an initiative to prevent, treat and study football-related injuries.

The Mayo Clinic calls the therapy a "game-changing area of medicine," offering effective therapy for people whose conditions seem beyond repair.

Griffeth, a University of Florida masters graduate, studied biotechnology and cell science. He became fascinated with the human anatomy and its ability to help itself when he was working in Fort Lauderdale, in 2009, doing clinical studies with patients with damaged heart tissue.

RBI, located in Vero Beach, is committed to using stem cells for regenerative healing therapies once available only to professional athletes.(Photo: Fran Foster)

We would take a muscle biopsy from the thigh muscle, isolate the stem cells from that, then culture and expand them for about three weeks in our laboratory, he explained. Then we would use those cells to inject directly into the heart wall to help the damaged heart tissue. Of those studies, about a third of patients were significantly better, another third somewhat and the last third stayed the same but thats not necessarily a bad thing considering they didnt decline.

Currently, RBI is working on orthopedic conditions: arthritis, knee and other sport injuries.

Regenerative medicine is also not without its detractors. The FDA has approved just a handful of procedures (mainly for blood diseases such as leukemia) and insurance doesnt cover the treatment which can run into the thousands of dollars.

However, there are very few known side effects and very little recovery time. Plus, it's a treatment that addresses the underlying cause degenerating tissue as opposed to just treating symptoms.

Darragh said the only discomfort she had was when the cells were discharged into her knee there really wasnt a lot of room in there.

The guys (at RBI) laughed at me and said, You are only the second person that has complained about that. The other was a CrossFit athlete with little to no body fat especially around her joints.

Nevertheless, she walked out just fine, the same day.

RBI Medical Director Dr. Brett Haake believes there are a lot of misunderstandings about what regenerative medicine can do, as well as the science behind it.

The first way the public came to know about stem cells was through the embryonic stem cell research debate, where you are potentially destroying embryos, and the politics that come around that discussion, he said.

Haake explains, Its a simple process. We make a small incision, which doesnt even require stitches, go in and retract the fatty tissues. In about 45 minutes, we can isolate and concentrate on stem cells, combine them with your own highly concentrated platelets, which have a ton of growth factors, and inject them back to the area needed perhaps an elbow, a knee or an ankle.

Darragh says she researched treatments extensively and recommends others do the same.

Having this regenerative therapy is one of the best three things Ive done for myself. I had no idea it was available, although its very prominent in Europe and a lot of athletes use it, she says. The procedure makes perfect sense to me in that my body is healing itself. Im not introducing foreign objects, putting it through surgical trauma, taking pain medications. Its literally taking cells from one area to help heal another area. Your own body is healing your own body.

In regards to the procedure being ineligible for insurance coverage, she said that her insurance deductible was just as high, if not higher.

And the procedure only took a few hours. She loved the fact that the staff at RBI explained the entire process with enthusiasm and really believe in the work they are doing.

I have to say it lived up to exactly what they said it would do. I was in and out of the office the same day and was moving around right away, she said. Eight weeks later, its better than it has been for the past five years. Im planning on going back this December to have them work on my shoulder next.

Regenerative Biologics Institute (RBI) is located at 3755 Seventh Terrace, Suite 102 in Vero Beach. Visit their website at http://www.rbistemcell.com or call 772-492-6973.

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Regenerative therapy is new frontier in injury recovery - TCPalm