ViaCyte, a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, has filed an Investigational New Drug application with the United States Food and Drug Administration, seeking to start a Phase 1/2 clinical trial in patients with type 1 diabetes, it was reported on Friday.

The trial will assess the safety and efficacy of ViaCyte's VC-01 product candidate, a stem cell-derived, encapsulated cell replacement therapy. The company has also submitted a Medical Device Master File to the United States Food and Drug Administration in support of the Encaptra drug delivery system, the device component of the VC-01 product candidate. The company's VC-01 product candidate includes pancreatic progenitor cells, called PEC-01 cells, which are derived from a proprietary human embryonic stem cell line.

Paul Laikind, Ph.D., president and chief executive officer of ViaCyte, said, 'The filing of this IND represents the culmination of many years of research and development by a dedicated team focused on developing a cell replacement therapy for patients with type 1 diabetes and advancing our VC-01 product candidate to human clinical trials. The ViaCyte team has been assisted and supported by the California Institute for Regenerative Medicine (CIRM) a leading organisation focused on advancing the field of stem cell-based technologies, and JDRF, the leading advocacy organisation for patients with type 1 diabetes.'

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ViaCyte asks FDA for go-ahead with human trials of cell replacement therapy for diabetes