Category Archives: Stem 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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DR ANDREW J ROCHMAN: ON STEM CELL THERAPY

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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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