Category Archives: Cell Therapy

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

Some people say that osteoarthritis, cartilage degradation, and chronic joint pains degenerative diseases associated with agingare conditions with no cure, but Dr. Charlie Poblete and Dr. Jae Pak say otherwise.

It is a new era of medicine, opens Dr. Jae Pak, one of Koreas premier orthopedic stem cell surgeons and a visiting expert consultant of the Stem Care Orthopedics Department under Aivee Institute (AI). He was recently in the country to shed light on stem cell therapy and how it offers more accessible treament options for patients suffering from degenerative orthopedic conditions.

Dr. Pak was joined by Dr. Charlie Poblete, one of the countrys leading orthopedic surgeon who has a special interest on regenerative medicine and stem cells. Incidentally, Dr. Poblete is the head of the Stem Care Orthopedic Department of AI. Stem cells are not really part of alternative medicine. Its part of a modern medicine because we are talking about the biochemistry that goes on in the body with stem cell treatment, Dr. Charlie relates while adding, the good thing about medicine nowadays is its starting to look at the molecular aspect of the body, the molecular and cellular side of medicine.

Over the years, stem cell therapy has been touted as one procedure that can heal multitude of bone, cartilage, and joint ailments. Stem cells are the bodys natural healing cells. They are recruited by chemical signals emitted by damaged tissues to repair and regenerate the damaged cells. Stem cells derived from an individuals tissues may well be the next major development in medicine. In the right environment, these stem cells can change into bone, cartilage, muscle, fat, collagen, neural tissue, blood vessels, and even some organs. Stem cells may also effect healing by secreting special chemical messengers that repair damaged tissue.

There are many clinical conditions that benefits from stem cell therapy: heart attack patients have shown quicker healing period, improved condition for patients with multiple sclerosis, muscular dystrophy, Parkinsons disease, ALS, and stroke. Stem cells may also be effective in the treatment of macular degeneration, Crohns disease, and numerous pulmonary conditions. Also, stem cells are now used for patients with kidney failure and in the treatment of critical limb ischemia.

Stem Cell therapy is a simple procedure. Fat is aspirated from the tummy or the thighs, and then we separate the stem cells from them. It is then activated and injected into joints to restore and regenerate, explains Dr. Jae.

Stem Care by The Aivee Group is the countrys pioneer in advanced Autologous Stem Cell Therapy with an esteemed orthopedic team of doctors and surgeons regarded with international qualifications. The institute, with its CEO and medical director Dr. Z. Teo, together with his wife dermatologist Dr. Aivee Teo, now features a stronger multifaceted protocol in treating orthopedic ailments with a faster rate of positive patient response. They are also adept in complimentary therapies to further intensify the restorative powers of stem cells through the effective use of Growth Factors, Shockwave, Radio Frequency, and Electro Magnetic Therapies. 4033245, 4031982, 09209665613, 09175210222. http://www.stemcareinstitute.com

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Restore and Regenerate

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Newswise In a groundbreaking study that provides scientists with a critical new understanding of stem cell development and its role in disease, UCLA researchers at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research led by Dr. Kathrin Plath, professor of biological chemistry, have established a first-of-its-kind methodology that defines the unique stages by which specialized cells are reprogrammed into stem cells that resemble those found in the embryo.

The study was published online ahead of print in the journal Cell.

Induced pluripotent stem cells (known as iPSCs) are similar to human embryonic stem cells in that both cell types have the unique ability to self-renew and have the flexibility to become any cell in the human body. iPSC cells, however, are generated by reprogramming skin or blood cells and do not require an embryo.

Reprogramming is a long process (about one to two weeks) and largely inefficient, with typically less than one percent of the primary skin or blood cells successfully completing the journey to becoming an iPSC. The exact stages a cell goes through during the reprogramming process are also not well understood. This knowledge is important, as iPSCs hold great promise in the field of regenerative medicine, as they can provide a single source of patient-specific cells to replace those lost to injury or disease. They can also be used to create novel disease models from which new drugs and therapies can be developed.

This research has broad impact, because by deepening our understanding of cell reprogramming we have the potential to improve disease modeling and the generation of better sources of patient-specific specialized cells suitable for replacement therapy, said Plath. This can ultimately benefit patients with new and better treatments for a wide range of diseases.

Drs. Vincent Pasque and Jason Tchieu, postdoctoral fellows in the lab of Dr. Plath and co-first authors of the study, developed a roadmap of the reprogramming process using detailed time-course analyses. They induced the reprogramming of skin cells into iPSC, then observed and analyzed on a daily basis or every other day the process of transformation at the single-cell level. The data were collected and recorded over a period of up to two weeks.

Plaths team found that the changes that happen in cells during reprogramming occur in a sequential stage-by-stage manner, and that importantly, the stages were the same across all the different reprogramming systems and different cell types analyzed.

The exact stage of reprogramming of any cell can now be determined, said Pasque. This study signals a big change in thinking, because it provides simple and efficient tools for scientists to study stem cell creation in a stage-by-stage manner. Most studies to date ignore the stages of reprogramming, but we can now seek to better understand the entire process on both a macro and micro level.

Excerpt from:
Scientists Develop Pioneering Method to Define Stages of Stem Cell Reprogramming

NEW YORK (TheStreet) -- Shares of stem cell therapy developerNeuralstem (CUR) rose 4.62% to $2.72 on higher-than-average volume in afternoon trading Wednesday in sympathy with peer companyBrainstorm Cell Therapeutics (BCLI) .

Brainstorm intends to release the final results from its Phase 2a trial of its stem cell therapy NurOwn on Monday. The company describes NurOwn as an "autologous, adult stem cell therapy technology" designed to treat ALS, also known as Lou Gehrig's Disease.

The company will host a conference call on Monday to discuss the results.

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An experimental treatment that uses a patient's own stem cells may offer new hope for people with multiple sclerosis.

In a small clinical trial, patients experienced long-term disease remission after undergoing a transplant of their own hematopoietic stem cells. This type of cell is responsible for the formation of blood in the body and are typically derived from bone marrow. The patients also took high-dose immunosuppressive drugs.

The paper, published Monday in JAMA Neurology, reports on the third year of a five-year study. A total of 24 patients with active relapsing-remitting MS were enrolled in the trial. With this type of MS, patients have points when their disease is active followed by periods when they do not experience any symptoms.

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Dr. Jon LaPook goes inside the trial and approval process for an experimental treatment using stem cells designed to make Multiple Sclerosis pati...

The researchers found that nearly 79 percent of the patients who underwent the procedure sustained full neurologic function for the three years following the treatment and symptoms of their disease did not progress. Additionally, patients in that time period did not develop any new lesions related to their disease.

More than 90 percent of patients did not experience disease progression, while 86 percent did not have any periods of relapse. Though a small number of patients did have side effects from the immunosuppressive drugs, they were no different than the side effects typically experienced by MS patients taking the drugs who haven't undergone stem cell therapy.

"Longer follow-up is needed to determine the durability of the response," the authors write in the study. "Careful comparison of the results of this investigation and other ongoing studies will be needed to identify the best approaches for high-dose immunosuppressive therapies for MS and plan the next clinical studies."

The authors of an accompanying editorial say the research indicates this type of therapy has potential to work on patients who do not experience disease remission with medications alone, such as immunosuppressive drugs and anti-inflammatory drugs such as corticosteroids.

However, they add that "the jury is still out regarding the appropriateness and indication" of stem cell transplants for MS patients. Stem cell therapy is not approved by the U.S. Food and Drug Administration for the treatment of MS. The National Multiple Sclerosis Society currently funds 15 research projects on stem cell therapies that have the potential to prevent disease activity and repair nerve damage.

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Stem cell transplant may help patients with MS

FAT STEM CELL COMBINED/ Stem Cell Therapy
Adipose-Derived Stem Cells derived from the patients own fat provides a rich source of adult mesenchymal stem cells as demonstrated by Dr. Hong in this sessi...

By: Kab S. Hong M.D.

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FAT STEM CELL COMBINED/ Stem Cell Therapy - Video

David Eller could have retired a long time ago.

At the age of 76, he could spend his days on permanent vacation fly-fishing in Idaho, golfing in San Antonio or skiing on the Italian-Austrian border like he has done to get away from work for many years.

He isn't working because he is desperate for money and accolades. He's had those for many years.

During the '80s, Eller oversaw revolutionary cattle cloning practices as CEO of Granada BioSciences, a company he founded. He served as chairman of the Texas A&M System Board of Regents from 1983 to 1989. The Oceanography & Meteorology Building on A&M's campus was named in his honor in 1988.In 2000, he was namedexecutive vice president and president of DuPont's European operations.He is president of Eller Holding Company, a privately-held family investment company.

Instead of settling down after a life of amassing great wealth and personal achievement, he co-founded Houston-based Celltex Therapeutics Corporation in 2011 and put himself at the forefront of the contentious issue of autologous stem cell therapy in the name of fighting for ill people to harness the healing properties of their own bodies.

These days it is Celltex that drives Eller's passion, enabling him to combine his humanitarian and entrepreneurial impulses and perhaps one day leave a lasting mark on health care. It is the culmination of the journey he began on the A&M campus in the late 1950s.

"When I started this company I really didn't need another job," Eller said. "I certainly didn't need one with so many rules and regulations we had to adhere to that gives us a lot of headaches. All in all, the biggest reward out of it is seeing people improve their quality of life."

Since 2011, the company has helped treat approximately 600 patients between the ages of 6 and 96 by injecting stem cells taken from their own bodies into a troubled area with no complications, according to Eller. He believes Celltex's reach could expand tenfold if the entire operation could be conducted out of the United States, where the practice was banned in 2012, but that could take years of fighting a two-front war.

The daily war is educating as many doctors and potential patients as possible on the benefits of being treated with a one's own stem cells. The second, long-term war is maneuvering through the FDA's web of red tape that currently bans the practice from being performed on U.S. soil.

Eller spent four years in the Texas A&M Corps of Cadets until his 1959 graduation, which he says plays a major role in his character.

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Aggie grad happy to put off retiring to advance stem cell science