CIRM video
The California stem cell agency’s $39 million investment
in a possible therapy for diabetes moved forward this week with the
announcement that the treatment could enter clinical trials as early as next
month.
ViaCyte, a San Diego, Ca., firm, and the agency announced
yesterday that the firm has applied with the FDA to start the testing to determine whether
the product is safe in human beings. The
Juvenile Diabetes Research Foundation, which is also funding the ViaCyte
product, said the therapy was “potentially transformative.”
Randy Mills, president of the $3 billion stem cell
agency, said in a press release,
“This is good news for ViaCyte and is a clear sign of the progress they are making. Filing for an IND is a crucial step along the path to bringing a stem cell treatment to patients. CIRM will be working with them and supporting them every step of the way to try and make this happen as quickly, and as safely, as possible.”
The agency described the treatment like this:
“Viacyte’s approach uses a thin plastic pouch, containing an immature form of pancreatic cells that, when implanted under the skin, are designed to mature and become insulin-producing and other cells needed to regulate blood glucose levels. These cells are able to sense when blood glucose is high, and then secrete insulin to restore it to a healthy level. In effect this is designed to mimic the glucose regulating functions of the pancreas, which, in people with T1D(type one diabetes), no longer works. This approach was shown to be effective in extensive preclinical testing in models of the disease.”
Paul Laikind, president of ViaCyte, told Bradley
Fikes of the San Diego U-T that if “all goes smoothly” the initial stage of the
clinical trials could begin next month or in September. Fikes also quoted the first chairman of the stem cell
agency, Robert Klein, whose son has diabetes, as saying,
"This is an exciting day for the father of any son or daughter who has Type 1 diabetes."
The therapy, which is based on human embryonic stem cells, could take years to successfully
complete all of the necessary clinical trials. Only one out of 10 possible
therapies that enter clinical trials enters the marketplace.
