Category Archives: Cell Therapy

ViaCyte, a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, has filed an Investigational New Drug application with the United States Food and Drug Administration, seeking to start a Phase 1/2 clinical trial in patients with type 1 diabetes, it was reported on Friday.

The trial will assess the safety and efficacy of ViaCyte's VC-01 product candidate, a stem cell-derived, encapsulated cell replacement therapy. The company has also submitted a Medical Device Master File to the United States Food and Drug Administration in support of the Encaptra drug delivery system, the device component of the VC-01 product candidate. The company's VC-01 product candidate includes pancreatic progenitor cells, called PEC-01 cells, which are derived from a proprietary human embryonic stem cell line.

Paul Laikind, Ph.D., president and chief executive officer of ViaCyte, said, 'The filing of this IND represents the culmination of many years of research and development by a dedicated team focused on developing a cell replacement therapy for patients with type 1 diabetes and advancing our VC-01 product candidate to human clinical trials. The ViaCyte team has been assisted and supported by the California Institute for Regenerative Medicine (CIRM) a leading organisation focused on advancing the field of stem cell-based technologies, and JDRF, the leading advocacy organisation for patients with type 1 diabetes.'

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ViaCyte asks FDA for go-ahead with human trials of cell replacement therapy for diabetes

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Stem Cell Research & Therapy | Full text ...

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DR ANDREW J ROCHMAN: ON STEM CELL THERAPY

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DR ANDREW J ROCHMAN: ON STEM CELL THERAPY - Video

Paul Laikind, CEO of ViaCyte, which is making a treatment for diabetes from human embryonic stem cells.

In an historic announcement for the stem cell field, San Diego's ViaCyte said Thursday it has applied to start human clinical trials of its treatment for Type 1 diabetes.

ViaCyte grows replacement insulin-producing cells from human embryonic stem cells. The cells are packaged while maturing in a semi-permeable device and implanted. In animal trials, the cells produce insulin, relieving diabetes.

Now the company proposes to take what could be a cure for diabetes into people. ViaCyte has asked to begin a Phase 1/2 clinical trial, which would assess both safety and efficacy of its product. ViaCyte is targeting Type 1 diabetes, in which the insulin-producing cells are destroyed. Patients require multiple injections of insulin daily to survive.

The announcement is good news for California's stem cell agency, the California Institute for Regenerative Medicine. The agency has awarded nearly $39 million to ViaCyte to ready its device for human use.

Paul Laikind, ViaCytes chief executive, said if all goes smoothly, the first patients will be treated in August or September. Based on animal studies, it will take a few months to see results, and just a few patients will be treated at first.

CIRM itself, funded with $3 billion in state bond funds, has come under pressure to show results from its work. The money is projected to run out in 2017. Some supporters of the agency have proposed launching a new initiative to continue funding.

"This is a great example of how the investment that the voters made in creating CIRM is beginning to move from labs to patients," said Joe Panetta, a member of CIRM's governing board and chief executive of Biocom, the San Diego-based life science trade group. ""There are at least a dozen other clinical trials in progress. This is good for CIRM and San Diego."

Jonathan Thomas, chairman of CIRM's governing board, called the filing "a big step in developing therapies for Type 1 diabetes."

"The project is one that has been front and center for us for six years," Thomas said. "As a principal funder of Viacyte since 2008, we are delighted that they have taken this major step towards getting a Type 1 Diabetes therapy to patients."

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Diabetes stem cell therapy readied

Phoenix, AZ (PRWEB) July 17, 2014

Arizona Pet Vet Family of Animal Hospitals is hosting San Diego, California based Regenerative Veterinary Medicine company, Vet-Stem, Inc., for a summer session of RACE approved Credentialing Courses and wet-labs on stem cell therapy. AZ Pet Vets Family of 17 Animal Hospitals has been offering Vet-Stems Regenerative Cell Therapy to its small animal patients since 2010, and continuously strives to educate their team members on cutting-edge services like stem cell therapy.

Since Vet-Stems last training session with AZ Pet Vet in the summer of 2013 the number of pets diagnosed with arthritis has increased as much as an estimated 13% say industry sources. As many as 65% of dogs between the ages of 7 and 11 years old will be inflicted with some degree of arthritis. For certain specific breeds the percentage is as high as 70%, with an additional estimated 7% remaining undiagnosed. AZ Pet Vets Family of Animal Hospitals equips their veterinarians with a complete package of services to help diagnose and treat dogs that are suffering pain or inflammation from osteoarthritis or polyarthritis. Stem cell therapy is one of these services, most commonly used to help decrease inflammation, help with the pain of osteo or polyarthritis, as well as other joint or ligament issues, and muscle injuries.

Vet-Stems Corey Orava, DVM will be leading a series of daily training sessions which include a RACE (Registry of Approved Continuing Education from the American Association of Veterinary State Boards) approved credentialing course, and the ability to consult on potential stem cell therapy cases with current patients of AZ Pet Vets Family of Animal Hospitals. Each of these sessions will help veterinarians and their staff to learn the ins and outs of stem cell therapy, as well as benefit from a hands-on experience to bring the best care to their patients and pet owners. Under the mentorship of Dr. Orava all of the 17 AZ Pet Vet Animal Hospitals will have the potential to collect fat and inject stem cells on qualifying pet patients.

AZ Pet Vet is a family of 17 animal hospitals with one vision: to provide the best comprehensive care for their highly valued patients. Whether it be routine wellness, or other type of medical care, AZ Pet Vet provides loving care and treatment for pets. As animal lovers and pet owners, they understand the connection owners have with your pet. The doctors and staff at each hospital strive to build a long term relationship with their client families and their pets, always making recommendations in the pets best health interest. The AZ Pet Vet Family of Animal Hospitals offer complete veterinary care from wellness, to vaccines, spays and neuters, dental, surgical and now regenerative medicine. Their animal hospital locations can be easily found at http://www.arizonapetvet.com/.

Since its formation in 2002, Vet-Stem, Inc. has endeavored to improve the lives of animals through regenerative medicine. As the first company in the United States to provide an adipose-derived stem cell service to veterinarians for their patients, Vet-Stem pioneered the use of regenerative stem cells for horses, dogs, cats, and some exotics. In 2004 the first horse was treated with Vet-Stem Regenerative Cell Therapy for a tendon injury that would normally have been career ending. Ten years later Vet-Stem celebrated its 10,000th animal treated, and the success of establishing stem cell therapy as a proven regenerative medicine for certain inflammatory, degenerative, and arthritic diseases. As animal advocates, veterinarians, veterinary technicians, and cell biologists, the team at Vet-Stem tasks themselves with the responsibility of discovering, refining, and bringing to market innovative medical therapies that utilize the bodys own healing and regenerative cells. For more information about Vet-Stem and Regenerative Veterinary Medicine, visit http://www.vet-stem.com or call 858-748-2004.

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Arizona Pet Vet, a Family of Animal Hospitals in Central Arizona, is Hosting Vet-Stem, Inc. for Continued Education ...

The Philippine College of Physicians has called on the public to undergo stem cell therapy treatment only in institutions that have the approval of the following agenciesDepartment of Health, Food and Drug Administration and Professional Regulation Commission.

PCP president Dr. Anthony Leachon saidthe three offices have agreed to implement new guidelines as regards stem cell treatment facilities.

"Kung hindi maayos ang facilities, hindi ito ma-aprubahan. 'Pag ang produkto ay hindi registered sa FDA, hindi pwede. At pangatlo, kung ang doktor ay hindi siya specialist.... Kapag isa lang doon ang mali, wala na. All or none," Leachon said.

He noted that clinics should have a sign in front with a "stamp of approval" from all three. "Huwag ka pumunta doon kung walang stamp," he added.

Leachon said that while the DOH evaluated the facilities of clinics, the FDA would check on the medicine to be used. The PRC, he said, would identify whether the doctor that will administer the theraphy is a certified specialist.

He also added that doctors should first conduct clinical trials of the services to be offered in the clinic.

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Stem cell clinics soon to need okay of 3 agencies

Tuesday 07/15: Dangerous Additives in Beer? Stem Cell Therapy; Summer Health Tips - Show Promo
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