JDRF Partner ViaCyte to Immediately Initiate Type 1 Diabetes Clinical Trial
JDRF’s partner ViaCyte recently announced the U.S. Food and Drug Administration (FDA) is allowing them to move forward with a clinical trial of its innovative type 1 diabetes (T1D) encapsulated cell replacement therapy called VC-01™ product candidate. The company plans to immediately initiate the first ever clinical evaluation of a stem cell-derived islet replacement therapy for the treatment of people with T1D. The trial will enroll approximately 40 people at multiple clinical sites.
“On behalf of JDRF, I congratulate ViaCyte for this milestone,” said Derek Rapp, JDRF president and CEO. “We are extremely pleased the FDA has allowed the company to move forward with a human clinical trial of its innovative type 1 diabetes (T1D) encapsulated cell replacement therapy called VC-01™ product candidate. We are hopeful that beta cell encapsulation therapy could one day virtually eliminate the daily management burden for those living with T1D.”
An important goal of the trial will be to assess the safety of the VC-01 product candidate. Other key information to be collected will include: measures of insulin production to provide evidence of potential efficacy, changes to the amount of administered injected insulin, and the incidence of hypoglycemia. JDRF is providing key funding to support ViaCyte’s first ever clinical study of this exciting experimental therapy.
JDRF has made its encapsulation research program a priority because of its potential to transform the way individuals with T1D manage their disease.
For more information or to support JDRF’s encapsulation research program, please click here.