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ViaCyte plans phase 1/2 clinical trial for candidate cell replacement therapy
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The FDA has accepted ViaCyte, Inc.’s investigational new drug application for its VC-01 candidate cell replacement therapy to treat type 1 diabetes, according to a company press release.
ViaCyte announced plans to initiate a phase 1/2 clinical trial to evaluate a stem cell-derived islet replacement therapy for type 1 diabetes treatment.
“We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to initiating this study shortly,” Paul Laikind, PhD, president and chief executive officer of ViaCyte. “The Commencement of this clinical trial marks a significant milestone for ViaCyte, as we being studying the use of the VC-01 product candidate for the treatment of type 1 diabetes. Instrumental in our ability to achieve this milestone are [the Juvenile Diabetes Research Fund], the leading global organization focused on type 1 diabetes (T1D) research, and the California Institute for Regenerative Medicine, a leading organization focused on advancing stem cell research and regenerative medicine.”
VC-01 consists of pancreatic progenitor cells encapsulated in ViaCyte’s Encaptra device. After implantation, the cells are designed to mature and change to insulin-producing beta and other endocrine cells to help regulate blood glucose.
The trial will be conducted among patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. Along with safety, the study will evaluate effectiveness in replacing lost endocrine function. Insulin production will also be evaluated by measuring C-peptide.