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.
Update: The University of California at San Diego has been selected to launch the first-ever human test of ViaCyte’s experimental encapsulated cell replacement therapy, called VC-01™ for the treatment of T1D. The JDRF-funded trial will begin soon with only a handful of pre-selected people receiving the implant. After evaluating the results from this group, up to 40 people will be enrolled into the study beginning early next year when more trial sites will be added. Additional study details can be found at ClinicalTrials.gov.
JDRF has made its encapsulation research program a priority because of its potential to transform the way individuals with T1D manage their disease.
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