Stem Cell Therapy for Erectile Dysfunction - Alvarado Hospital
The first study in the U.S. to determine if stem cell therapy can treat erectile dysfunction. Alvarado Hospital #39;s Drs. Irwin Goldstein and Barry Handler discuss this FDA-approved study and...

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terapia celular para cinomose - distemper stem cell therapy
Caso de cinomose tratado com terapia celular - unesp - botucatu Stem cell therapy for distemper in a dog.

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terapia celular para cinomose - distemper stem cell therapy - Video

Stem-cell advocates pin their hopes on an artificial pancreas to treat diabetes.

Fourteen years ago, during the darkest moments of the stem-cell wars pitting American scientists against the White House of George W. Bush, one group of advocates could be counted on to urge research using cells from human embryos: parents of children with type 1 diabetes. Motivated by scientists who told them these cells would lead to amazing cures, they spent millions on TV ads, lobbying, and countless phone calls to Congress.

Now the first test of a type 1 diabetes treatment using stem cells has finally begun. In October, a San Diego man had two pouches of lab-grown pancreas cells, derived from human embryonic stem cells, inserted into his body through incisions in his back. Two other patients have since received the stand-in pancreas, engineered by a small San Diego company called ViaCyte.

Its a significant step, partly because the ViaCyte study is only the third in the United States of any treatment based on embryonic stem cells. These cells, once removed from early-stage human embryos, can be grown in a lab dish and retain the ability to differentiate into any of the cells and tissue types in the body. One other study, since cancelled, treated several patients with spinal-cord injury (see Geron Shuts Down Pioneering Stem-Cell Program and Stem-Cell Gamble), while tests to transplant lab-grown retina cells into the eyes of people going blind are ongoing (see Stem Cells Seem Safe in Treating Eye Disease).

Type 1 patients must constantly monitor their blood glucose using finger pricks, carefully time when and what they eat, and routinely inject themselves with insulin that the pancreas should make. Insulin, a hormone, triggers the removal of excess glucose from the blood for storage in fat and muscles. In type 1 diabetics, the pancreas doesnt make it because their own immune system has attacked and destroyed the pancreatic islets, the tiny clusters of cells containing the insulin-secreting beta cells.

The routine is especially hard on children, but if they dont manage their glucose properly, they could suffer nerve and kidney damage, blindness, and a shortened life span. Yet despite years of research, there is still just nothing to offer patients, says Robert Henry, a doctor at the University of California, San Diego, whose center is carrying out the surgeries for ViaCyte.

Henry slightly overstates the case, but not by much. There is something called the Edmonton Protocol, a surgical technique first described in the New England Journal of Medicine in 2000. It used islets collected from cadavers; by transplanting them, doctors at the University of Alberta managed to keep all seven of their first patients off insulin for an entire year.

Early hopes for the Edmonton Protocol were quickly tempered, however. Only about half of patients treated have stayed off insulin long-term, and the procedure, which is still regarded as experimental in the U.S., isnt paid for by insurance. It requires recipients to take powerful immune-suppressing drugs for life. Suitable donor pancreases are in extremely short supply.

The early success of the Edmonton Protocol came only two years after the discovery of embryonic stem cells, in 1998. Those pressing for a diabetes cure quickly set a new goal: pair something like the Edmonton Protocol with the technology of lab-grown beta cells, the supplies of which are theoretically infinite.

This biocompatible capsule is designed to protect manufactured pancreas cells.

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A Pancreas in a Capsule

Research scientists (from left) Dr Jim Faed, Vicky Nelson and Dr Paul Turner talk about the possibilities of finding a cure for type 1 diabetes, during the Lion's Lark in the Park at the Dunedin Botanic Garden yesterday. Photo by Gregor Richardson.

Cell biologist, haematologist and project leader Dr Jim Faed, of the University of Otago, made the promise during the Lion's Lark in the Park event at Dunedin's Botanic Garden yesterday, which aimed to help raise some of the $2.46 million needed to run the trials.

Dr Faed said their research involved trials using stem cells taken from the bone marrow of people with type 1 diabetes, and using them to stimulate insulin production.

The cells appeared to be able to ''turn off'' the auto immune response that causes type 1 diabetes, he said.

''We see this as the low hanging fruit of research into a cure for type 1 diabetes because it has already been done once before.''

Trials had already been carried out on mice and humans. It just needed fine tuning, he said.

Much of the funds raised would go towards the Spinal Cord Society which will develop its stem cell production facilities in Dunedin, so that patients' own cells can be grown and tested in clinical trials.

''It's the only method that's attacking the cause of diabetes. Most of the other treatments are basically designed to manufacture insulin artificially.

''What we are looking for is a cure, not just support of people with the disease.

''This will be a sustained cure that doesn't require top ups.''

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Stem cells cure hope for diabetes

Neck and Shoulder arthritis two years after stem cell therapy by Harry Adelson, N.D.
Steve describes his outcome two years after stem cell therapy for his arthritic neck and shoulder by Dr Harry Adelson http://www.docereclinics.com.

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Neck and Shoulder arthritis two years after stem cell therapy by Harry Adelson, N.D. - Video

Nicholasville, KY (PRWEB) February 04, 2015

Rescued when he was only 4 weeks old, Nakiia, a 15-year-old Panther, has been living in severe pain after a jumping incident. Jan Hall, Nakiias owner has dedicated her life to rescuing animals. Nakiia, the namesake of her rescue foundation The Nakiia Foundation is the love of her life. Witnessing this fabulous animal in such pain was too much for Jan to bear. The Doctors treating Nakiia decided to undertake a revolutionary medical procedure, which centers on regenerative medicine.

Newman Veterinary Center in DeLand Florida performed MediVets Adipose (fat)-derived stem cell therapy. The male Florida panther underwent this procedure, more commonly performed on domestic animal such as dogs, cats and horses. The procedure is an effort to ease the pain from severe arthritis in his joints. This was a last stage effort for the panther that can no longer continue to live in such pain.

Though stem cell treatments have been performed in exotic animals before, it is still a rare and exciting undertaking. Utilizing MediVet Biologics procedure, Dr. Ted Oliver was able to ensure the process will produce the best possible results. MediVets procedure is completed in one day and in-clinic.

Stem Cell treatments in the past have often been controversial when embryonic cells where involved, with adipose or fat tissue Nakiias own adult stem cells could be easily concentrated and activated with minimal risk. Until recently Veterinarians only had the option of utilizing outside labs for processing of autologous cells, with the one step surgical treatment available from MediVet Biologics, Veterinarians all around the country can eliminate the costs and variability in shipping by utilizing an onsite simple procedure.

During the procedure, Dr. Oliver removed about four tablespoons of belly fat from the panther. The fat was then processed in-clinic by a trained technician. The cells are incubated, isolated and activated by a patented process. Dr. Oliver carefully re-administered the cells directly back into Nakiia. Nakiias excess cells will be stored for future use eliminating the need to surgically re-harvest additional tissue.

MediVets primary mission and goal is to help all animals live a pain free life. In regenerative medicine and biologic intervention age is not a disease rather a challenge that presents us many opportunities to develop cutting edge treatments to combat issues related to the aging process. Our partnerships with progressive Veterinarians such as Newman Veterinary Centers allow us to extend affordable cutting edge treatments to animals who otherwise potentially have limited treatments available. We look forward to following Nakiias progress." - Jeremy Delk, CEO of MediVet Biologics.

Newman Veterinary Center was honored to be a part of Nakiias stem cell procedure. The excitement that this 146-lb. cat brought to our clinic was unparalleled. We have very high hopes that Nakiia will be feeling much better very soon. - Erica Kent Director of Operations at Newman Veterinary Centers.

Nakiias story will air on Wednesday, February 4th on CBS WKMG (local 6) with Mike Holfeld, Investigative Reporter.

About MediVet Biologics MediVet Biologics is the Worlds leading provider of Veterinary regenerative medicine. The central Kentucky based company was founded in 2009 and quickly gained favor in the Veterinary industry with the advent of in-clinic adipose derived stem cell and platelet rich plasma treatments. Since gaining wide appeal in the small and large veterinary market MediVet Biologics has developed a strong biologic pipeline that includes, among other cutting edge treatment options, patient specific immunotherapy services.

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Florida Panther Receives Cutting Edge Stem Cell Procedure from MediVet Biologics

Peek the American black bear (Courtesy: Topeka Zoo)

Peek the bear is shown undergoing a CT scan at St. Francis Health Center in this photo from the Topeka Zoo.

St. Francis Health Center staff watch as a CT scan is performed on Peek the black bear. (Courtesy: Topeka Zoo)

TOPEKA, Kan. (WIBW) - An American black bear at the Topeka Zoo may be the first bear ever to undergo stem cell treatment for a spinal problem.

Zoo Director Brendan Wiley says Peek, who is 20-years old, started losing control of her hind legs two weeks ago. The condition worsened and zoo staff says pain medication was not having any impact on the situation.

One of the unique things about this scenario is that Peek hasnt acted like anything is hurting her. It is like the front half of her body can no longer communicate with the back half, said Animal Care Supervisor Shanna Simpson.

The zoo worked with St. Francis Health Center to perform a CT scan. Peek was tranquilized and transported to St. Francis' imaging facilities.

"Our first priority is human patient safety and access," says Brent Wilkins, director of Imaging Services at St. Francis Health. "We work with the Topeka Zoo to accommodate animals that need CT scans in off hours when one of our CT scanners is available. We made sure the bear was separated from any other patients and performed a high-level decontamination and cleaning of the area, called a terminal cleaning, after the bears visit."

The scan revealed an area of Peek's spine with spinal stenosis, a narrowing of her spinal column, causing pressure on the spinal cord.

In anticipation of future treatment, Dr. Larry Snyder and Dr. Travis Gratton, veterinarians from Topeka's University Small Animal Hospital were contacted. Before Peek was transported for the CT scan, the two harvested fat cells, which they converted to stem cells to inject back into her. The theory behind the treatment is that the stem cells can stimulate damaged area to repair and heal itself.

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Newswise Two scientists from the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have received a California Institute of Regenerative Medicine (CIRM) Tools and Technology Award that will forward revolutionary stem cell medicine. The UCLA researchers were among only 20 scientists nationwide to receive the Tools and Technologies Award, the most of any institution represented.

Recipients receiving awards for their respective projects included Dr. James Dunn, professor of bioengineering and surgery, for his research investigating skin-derived precursor stem cells for the treatment of enteric neuromuscular dysfunction, and Dr. Hanna Mikkola, associate professor of molecular, cell and developmental biology, for her work creating a suite of engineered human pluripotent stem cell lines to facilitate the generation of patient specific hematopoietic stem cells.

UCLA Broad Stem Cell Research Center Director Owen Witte said, We are very grateful for CIRMs support of these potentially groundbreaking projects intended to overcome significant bottlenecks in driving stem cell therapies to the clinic.

The CIRM Tools and Technologies initiative is designed specifically to support research that can address regenerative medicines unique translational challenges. The award seeks to facilitate the creation, design and testing of broadly applicable novel tools and technologies for addressing translational bottlenecks to stem cell therapies.

Dr. James Dunn: Unlocking the Secrets of Neuromuscular Dysfunction

Dr. Dunns cutting-edge work focuses on assessing the therapeutic potential of skin-derived stem cells to treat neuromuscular gastrointestinal diseases. CIRM reviewers noted that, if successfully completed, the project would likely have a major impact upon the field. His lab will develop a model of intestinal neuromuscular dysfunction that is amenable to stem cell transplantation.

Dunns novel approach to treat these patients will use stem cells reprogrammed from the patients own skin (induced pluripotent stem cells) to generate the neural system to correct the intestinal dysfunction. Dunn and his team hope the research will result in a clinical trial using patient specific induced pluripotent stem cells and provide a critical step toward an improved therapeutic approach and to treat intestinal neuromuscular dysfunction.

Dr. Dunns research was additionally supported by the National Institutes and Sun West Company.

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UCLA Researchers Receive Prestigious CIRM Tools and Technologies Award

TORONTO - Gordie Howe's son says the hockey legend's stroke symptoms have improved since his treatment with stem cells at a Mexican clinic in early December and he wants him to repeat the procedure.

But regenerative medicine experts say there's no scientific evidence such therapies work, and in some cases they can be seriously harmful or even deadly.

The 86-year-old Howe suffered two disabling strokes late last year. In December, the family took him to a Tijuana clinic where he received stem cell injections as part of a clinical trial being run under a licensing agreement with Stemedica Cell Technologies of San Diego, Calif.

The experimental treatment involved injecting neural stem cells into Howe's spinal canal, along with intravenous infusions of mesenchymal stem cells, which are found in bone marrow, fat and umbilical cord blood.

Marty Howe said his father can walk again, his speech is improving and he is regaining some of the weight he lost following the strokes.

"After his stem cell treatment, the doctor told us it was kind of an awakening of the body, and it was all that," he told The Canadian Press while in Calgary for a hockey promotion event Tuesday. "They call it the miracle of stem cells and it was nothing less than a miracle."

However, experts in the field question whether stem cells are responsible for Howe's improvement and caution that most so-called stem cell therapies have not gone through rigorous scientific trials, nor have they been approved as treatments by Health Canada or the U.S. Food and Drug Administration.

Mick Bhatia, director of McMaster University's Stem Cell and Cancer Research Institute, said there are many unknowns in Howe's case, such as how many stem cells were administered, were tests done to see whether they migrated to the targeted area of the body, and did they take up residence where they might have some effect or simply disappear?

"Is this a transient effect, or is it really a perceived or somewhat of a placebo effect and is there something really happening? Scientifically and biologically that is important," Bhatia said Wednesday from Hamilton.

And because Howe received adult stem cells produced from donor cells, he may have needed to take drugs to prevent an immune reaction as well as anti-inflammatory medications, he said.

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TORONTO - Gordie Howe's son says the hockey legend's stroke symptoms have improved since his treatment with stem cells at a Mexican clinic in early December and he wants him to repeat the procedure.

But regenerative medicine experts say there's no scientific evidence such therapies work, and in some cases they can be seriously harmful or even deadly.

The 86-year-old Howe suffered two disabling strokes late last year. In December, the family took him to a Tijuana clinic where he received stem cell injections as part of a clinical trial being run under a licensing agreement with Stemedica Cell Technologies of San Diego, Calif.

The experimental treatment involved injecting neural stem cells into Howe's spinal canal, along with intravenous infusions of mesenchymal stem cells, which are found in bone marrow, fat and umbilical cord blood.

Marty Howe said his father can walk again, his speech is improving and he is regaining some of the weight he lost following the strokes.

"After his stem cell treatment, the doctor told us it was kind of an awakening of the body, and it was all that," he told The Canadian Press while in Calgary for a hockey promotion event Tuesday. "They call it the miracle of stem cells and it was nothing less than a miracle."

However, experts in the field question whether stem cells are responsible for Howe's improvement and caution that most so-called stem cell therapies have not gone through rigorous scientific trials, nor have they been approved as treatments by Health Canada or the U.S. Food and Drug Administration.

Mick Bhatia, director of McMaster University's Stem Cell and Cancer Research Institute, said there are many unknowns in Howe's case, such as how many stem cells were administered, were tests done to see whether they migrated to the targeted area of the body, and did they take up residence where they might have some effect or simply disappear?

"Is this a transient effect, or is it really a perceived or somewhat of a placebo effect and is there something really happening? Scientifically and biologically that is important," Bhatia said Wednesday from Hamilton.

And because Howe received adult stem cells produced from donor cells, he may have needed to take drugs to prevent an immune reaction as well as anti-inflammatory medications, he said.

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Gordie Howe's stem cell therapy raises concerns among experts

Stem Cell Therapy + PRP Helps Shoulder Injury and Whiplash Patient - Denise Lawson
Denise Lawson experienced two motor vehicle accidents in 2001 that left her with neck pain, headaches, and sporadic episodes of weakness on the left side of her body. Over time, Denise developed...

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Stem Cell Therapy + PRP Helps Shoulder Injury and Whiplash Patient - Denise Lawson - Video

13 ABC: Advancements in stem cell therapy - 1/27/15
ProMedica Physician Roger Kruse, MD, discusses use of stem cell therapy in orthopedic care.

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13 ABC: Advancements in stem cell therapy - 1/27/15 - Video

Stem Cell Therapy Treatment for Limb Girdle Muscular Dystrophy by Dr.PV Mahajan
Patient testimonial of Limb Girdle Muscular Dystrophy treated by StemRx Bioscience Solutions Pvt. Ltd.

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Stem Cell Therapy Treatment for Limb Girdle Muscular Dystrophy by Dr.PV Mahajan - Video

Cost of Stem Cells Transplant in Mexico l Placid Answer
In this Video you can get the best answers for your questions about Cost of Stem Cells Transplant in Mexico! http://www.placidway.com/answer-detail/1477/What-is-the-cost-of-stem-cells-transplant-...

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Thursday 01/22: Celebrity Transformations; Stem Cell Therapy Debate; Samantha Harris Health Crisis
http://www.thedoctorstv.com Subscribe to The Doctors: http://bit.ly/SubscribeTheDrs LIKE us on Facebook: http://bit.ly/FacebookTheDoctors Follow us on Twitter: http://bit.ly/TheDrsTwitter Follow...

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Thursday 01/22: Celebrity Transformations; Stem Cell Therapy Debate; Samantha Harris Health Crisis - Video

FRESNO, Calif. (KFSN) --

Our bodies contain 23 pairs of them, 46 total. But if chromosomesare damaged, they can cause birth defects, disabilities, growth problems, even death.

Case Western scientist Anthony Wynshaw-Boris is studying how to repair damaged chromosomes with the help of a recent discovery. He's taking skin cells and reprogramming them to work like embryonic stem cells, which can grow into different cell types.

"You're taking adult or a child's skin cells. You're not causing any loss of an embryo, and you're taking those skin cells to make a stem cell." Anthony Wynshaw-Boris, M.D., PhD, of Case Western Reserve University, School of Medicine told ABC30.

Scientists studied patients with a specific defective chromosome that was shaped like a ring. They took the patients' skin cells andreprogrammed them into embryonic-like cells in the lab. They found this process caused the damaged "ring" chromosomes to be replaced by normal chromosomes.

"It at least raises the possibility that ring chromosomes will be lost in stem cells," said Dr. Wynshaw-Boris.

While this research was only conducted in lab cultures on the rare ring-shaped chromosomes, scientists hope it will work in patients with common abnormalities like Down syndrome.

"What we're hoping happens is we might be able to use, modify, what we did, to rescue cell lines from any patient that has any severe chromosome defect," Dr. Wynshaw-Boris explained.

It's research that could one day repair faulty chromosomes and stop genetic diseases in their tracks.

The reprogramming technique that transforms skin cells to stem cells was so ground-breaking that a Japanese physician won the Nobel Prize in medicine in 2012 for developing it.

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Stem Cells to Repair Broken Chromosomes: Medicine's Next Big Thing?

Bristol-Myers Squibb Co. (BMY: Quote) has entered into a clinical collaboration agreement with Eli Lilly and Co. (LLY: Quote) to explore combination regimens from its immuno-oncology portfolio with other mechanisms of action that may accelerate the development of new treatment options for patients.

As per the agreement terms, a phase 1/2 trial will evaluate Bristol-Myers Squibb's approved immunotherapy Opdivo in combination with Lilly's investigational Galunisertib as a potential treatment option for patients with advanced (metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma and non-small cell lung cancer.

Opdivo is approved by FDA for intravenous use for the treatment of patients with unresectable or metastatic melanoma while Galunisertib is currently under investigation as an oral treatment for advanced/metastatic malignancies, including phase 2 evaluation in hepatocellular carcinoma, myelodysplastic syndromes (MDS), glioblastoma, and pancreatic cancer.

In other related news, Lilly has also entered into a collaboration agreement with Merck & Co. Inc. (MRK: Quote) to evaluate the safety, tolerability and efficacy of Merck's KEYTRUDA in combination with Lilly compounds in multiple clinical trials.

Merck's KEYTRUDA was granted accelerated approval by FDA last September for unresectable or metastatic melanoma with disease progression following Ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

BMY closed Tuesday's trading at $63.12, up 1.51%.

Celsus Therapeutics plc (CLTX: Quote) has completed enrollment in its phase II study evaluating the safety and efficacy of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis.

The topline data from the trial are expected by end-February, 2015.

CLTX closed Tuesday's trading 10.39% higher at $5.95.

Cellular Dynamics International (ICEL: Quote) has entered into a research collaboration with privately-held Cord Blood Registry to reprogram newborn stem cells into induced pluripotent stem cells.

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LLY Collaborates With BMY And MRK, CLTX On Watchlist, ZLTQ Continues To Grow

A pioneering bone marrow post-transplant specialist nurse is introduced in Tyneside - the first post of its kind outside London.

Leading blood cancer charity Anthony Nolan has introduced the role based at the Northern Centre for Cancer Care, at Newcastles Freeman Hospital.

Susan Paskar has been employed in the job, funded by Anthony Nolan, to support patients with leukaemia and other blood cancers who have had bone marrow or stem cell transplants.

The 38-year-old will be patients dedicated point of contact at the hospital once they have been allowed to go home following their transplant and will be able to offer specialist support and advice.

Susan, who lives in Newcastle and has worked with bone marrow transplant patients at the Freeman Hospital for four years, said: I was very happy to take up this position as I saw that there was a need for more follow-up for patients they get a lot of support early on but we need to be able to continue to support them after their transplants so they can have the best possible quality of life.

I think the patients would tell you that this new role is a vital one. After their initial treatment comes to an end, patients will need long-term monitoring and they are often left with a lot of problems which may need further intervention, and many patients will need extra support to help them get used to the new normal.

Susan will also be able to refer patients to other services, such as dieticians, and to help them overcome any physical and psychological difficulties they experience after their transplant.

She added: It is a very rewarding job as you maintain your relationships with patients for a long time. You get to know your patients, and their families, really well.

Anthony Nolan is introducing three specialist nurse positions as part of its focus on improving quality of life for people after a transplant.

The first nurse, Hayley Leonard, has already taken up a position at The Royal Marsden in London. Susan took up her role in Newcastle in December and a third nurse will be recruited to work at Manchester Royal Infirmary and The Christie, in Manchester.

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Post-transplant specialist nurse is introduced in Newcastle Freeman Hospital

Researchers at King's College London have identified a new mechanism by which skin damage triggers the formation of tumours, which could have important therapeutic implications for patients suffering with chronic ulcers or skin blistering diseases.

The study, published today in Nature Communications, highlights an innate sensing of bacteria by immune cells in the formation of skin tumours. This molecular process could tip the balance between normal wound repair and tumour formation in some patients, according to researchers.

Although an association between tissue damage, chronic inflammation and cancer is well established, little is known about the underlying cause. Epidermolysis Bullosa (EB), for instance, is one of several rare inherited skin conditions associated with chronic wounding and increased risk of tumours.

However, this study - funded primarily by the Medical Research Council (MRC) and the Wellcome Trust - is the first to demonstrate that bacteria present on the skin can contribute to the development of skin tumours.

Researchers found that when mice with chronic skin inflammation are wounded they develop tumours at the wound site, with cells of the immune system required for this process to take place. They discovered that the underlying signalling mechanism involves a bacterial protein, flagellin, which is recognised by a receptor (Toll-like receptor 5) on the surface of the immune cells.

Although the direct relevance to human tumours is yet to be tested, researchers have shown that a protein called HMGB1 - found to be highly expressed in mice with chronic skin inflammation - is increased in human patients with Epidermolysis Bullosa (EB). The study found a reduction in HMGB1 levels in mice when the TLR-5 receptor was removed from immune cells. This raises the possibility of future treatments aimed at reducing levels of the flagellin bacterial protein on the skin surface, or targeting the TLR-5 receptor.

Professor Fiona Watt, lead author and Director of the Centre for Stem Cells and Regenerative Medicine at King's College London, said: 'These findings have broad implications for various types of cancers and in particular for the treatment of tumours that arise in patients suffering from chronic ulcers or skin blistering diseases.

'In the context of chronic skin inflammation, the activity of a particular receptor in white blood cells, TLR-5, could tip the balance between normal wound repair and tumour formation.'

Professor Watt added: 'Our findings raise the possibility that the use of specific antibiotics targeting bacteria in wound-induced malignancies might present an interesting clinical avenue.'

###

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Bacteria could contribute to development of wound-induced skin cancer

Published 07 January 2015

Gamida Cell, a leader in cell therapy technologies and products for transplantation and adaptive immune therapy, announced that orphan drug designation has been granted by The US Department of Health and Human Services, The FDA Office of Orphan Products Development (OOPD) for the investigational medicinal product NiCord for the treatment of acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), Hodgkin lymphoma and myelodysplastic syndrome (MDS).

The FDA orphan drug designation coincides with the positive opinion of the European Medicines Agency's (EMA's) Committee for Orphan Medicinal Products (COMP) regarding NiCord as a treatment for AML. Gamida Cell intends to file for NiCord orphan drug status with the EMA for other indications as well.

"Receipt of orphan drug status for NiCord in the US and Europe advances Gamida Cell's commercialization plans a major step further, as both afford significant advantages. We very much appreciate the positive feedback and support of the FDA and EMA and look forward to continuing what has been a very positive dialogue with these important agencies," said Gamida Cell president and CEO Dr. Yael Margolin.

The FDA and EMA grant an orphan drug designation to promote the development of products that demonstrate promise for the treatment of rare diseases or conditions. Orphan drug designation provides for various regulatory and economic benefits, including seven years of market exclusivity in the U.S. and 10 years in the EU.

NiCord is derived from a single cord blood unit which has been expanded in culture and enriched with stem cells using Gamida Cell's proprietary NAM technology.

It is currently being tested in a Phase I/II study as an investigational therapeutic treatment for hematological malignancies such as leukemia and lymphoma. In this study, NiCord is being used as the sole stem cell source.

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Gamida Cell's NiCord gets FDA and EMA orphan drug status