In search of a 'virtual cure' for diabetes

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

San Diego-based ViaCyte has received FDA permission to try its stem cell-based diabetes therapy. The Phase 1/2 combination trial will look for both safety and early signs of efficacy.

ViaCyte grows replacement insulin-producing cells from human embryonic stem cells, which are placed in a semipermeable pouch. The pouch will be implanted into patients, allowing insulin and other hormones to enter the patient's bloodstream.

The combination product of pouch and cells is called VC-01. ViaCyte says the product has the potential to provide a "virtual cure" for Type 1 diabetes. The company announced last month it had applied to begin the clinical trial.

Animal trials have shown that the replacement cells successfully duplicate the function of the insulin-producing beta cells. These cells secrete not only insulin, which lowers blood sugar, but hormones such as glucagon, which raises it. Providing a range of hormones as in the natural pancreas is expected to provide better control of blood sugar than with insulin alone.

The green light is not only good news for privately held ViaCyte, but for California's stem cell agency, the California Institute for Regenerative Medicine. The agency has granted ViaCyte more than $38 million to research and develop the treatment. CIRM has been under pressure in recent years to show that its $3 billion in state bond funding is leading to therapies.

CIRM was created to help develop stem cell treatments for diseases that are currently incurable with traditional approaches, C. Randal Mills president and CEO of the stem cell agency, said in an agency statement. Working in collaboration with CIRM for the past 6 years, ViaCyte has developed a particularly novel approach to overcome the challenges of treating type 1 diabetes. Anytime a product, particularly one as innovative as this one, progresses from the lab and into clinical trials its very encouraging news, particularly for the patients suffering from the disease.

The ViaCyte team is very pleased to have received FDA acceptance for our clinical trial protocol and look forward to initiating this study shortly, ViaCyte president and CEO Paul Laikind said in the statement. The commencement of this trial marks a significant milestone that could not have been achieved without the support we have received and continue to receive from CIRM.

Inadequate control of blood sugar increases the risk of heart disease, stroke, kidney failure and other complications of diabetes.

The ViaCyte product contains immature beta cells, grown from the embryonic stems cells. After implantation, the cells mature and begin to release the appropriate hormones in response to blood sugar levels.

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In search of a 'virtual cure' for diabetes