ViaCyte, a regenerative medicine company, announced the preliminary clinical data from its stem cell-derived islet cell replacement therapy, PEC‑Direct (VC-02), for patients with type 1 diabetes.
The early data proved positive, with the potential therapy able to show improvement to a patient who displayed glucose-responsive insulin production, after the implantation of pancreatic progenitor cells.
The snippet of data provided by the company showed that, during the nine-month study period, the patient experienced an increased time in range from 54% to 88% at week 42, and a 0.8% reduction of HbA1C from 7.4% to 6.6% at week 39. As a result, the company suggestive that this could indicate improved control of blood glucose associated with the delivery of the therapy.
Manasi Sinha Jaiman, VP of clinical development at ViaCyte, stated that this approach, with “optimisation”, could “fundamentally change the management of type 1 diabetes.”
What this could mean for patients was expressed by the company’s chief medical officer, Howard Foyt, as he stated that the data represented “progress toward our mission of a functional cure for type 1 diabetes.”
A further Phase II clinical trial is currently on going to determine the safety and efficacy of PEC-Direct.
Delivery through implant
PEC-Direct (VC-02) is a pouch containing PEC-01 cells that is implanted into the patient. The pouch itself is designed to allow blood vessels to enter the device and therefore directly interact with the implanted PEC-01 cells.
Due to the vascularization of the implanted cells, immune suppression therapy is necessary for patients receiving the treatment. As such, the company will seek to treat only patients with high-risk type 1 diabetes.
The cells contained within the device are pancreatic progenitor cells that mature into human islet tissue, which includes glucose-responsive insulin-secreting beta cells and other cells of the islet that are responsible for regulating blood glucose.
Manufacturing the cells
According to ViaCyte, the supply of PEC-01 cells is ‘potentially unlimited’ due to the cells being manufactured from a pluripotent stem cell line. The company was previously granted a patent for the manufacture of pancreatic progenitor cells from definitive endoderm cells.
Beyond the PEC-Direct program, ViaCyte is also working with CRISPR Therapeutics to use gene-editing technology to create an immune-evasive version of its pluripotent stem cell line.
This could allow for the elimination of any need for patients to take immunosuppressants, potentially broadening the pool of patients eligible to receive PEC-Direct beyond those with high-risk type-1 diabetes.
