The US Food and Drug Administration have approved human trials for a new technique of implanting insulin producing islet cells.
The product that has received approval is called VC-01, with VC standing for ‘virtual cure’. VC-01 involves a capsule, called the Encaptra drug delivery system, being implanted under the skin. Within the Encaptra system are stem cells, called PEC-01 cells, which have been programmed to develop into insulin producing islet cells.
The Encaptra system has life changing properties for people with type 1 diabetes as it allows insulin to pass out of the capsule, nutrients such as glucose and oxygen to pass into the capsule to feed the living cells yet protects the cells from the immune attack of type 1 diabetes.
The major problem in type 1 diabetes is that the immune system gets incorrectly programmed to attack insulin producing cells. The human clinical trials will therefore allow ViaCyte, the company that has developed the VC-01 system, to test how strongly the technique performs in humans with type 1 diabetes.
ViaCyte has received an important boost this week, towards funding human trials, as the company has recently received $20 million (around £12 million) from the large pharmaceutical firm Johnson and Johnson. The new technology from ViaCyte also has the type 1 diabetes charity, the JDRF, to thank for help in funding earlier development work.
The FDA approval means that the VC-01 product can begin phase I and phase II human clinical trials to test whether the islet cell encapsulation therapy is effective within humans.
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