A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness


Sponsored by ViaCyte, in collaboration with California Institute for Regenerative Medicine (CIRM)

Focus Areas: Beta Cell Therapies

What is This Study?

In this Phase 1 and Phase 2 trial also known as PEC-Direct, ViaCyte is testing whether or not their VC-02 device can be implanted and maintained safely for up to two years, as well as if the product can be an effective treatment. The device contains ViaCyte’s PEC-01 cells, which are derived from stem cells and designed to mature into human pancreatic islet cells, including glucose-responsive insulin-secreting beta cells, following implant.

Why do We Care?

There is a lot to be excited about here! If PEC-01 cells prove to be functional, this would solve a major barrier to beta cell therapy—a lack of donor beta cells. In October of 2019, ViaCyte presented positive preliminary data that showed their PEC-01 cells are capable of producing C-peptide in patients with type 1 diabetes. C-petide is a biomarker for insulin and is used for assessing insulin-producing cells in patients with type 1 diabetes (T1D). Unlike their other trial, PEC-Encap, this trial is only for high-risk patients, as it requires immunosuppression.

When Might we See Results?

Preliminary results were presented in October 2019, and the estimated primary completion date is late 2020 (with a secondary completion date of March 2022)

Further Reading

Implanted PEC-01 Cells Capable of Producing Insulin According to New Data Presented from ViaCyte

ViaCyte presented preliminary data from their PEC-Direct trial, showing that PEC-01 cells are capable of producing insulin in patients with type 1 diabetes.MORE

Stay tuned for in-depth coverage from Beyond Type 1 on the results of this study. To learn more about this trial click here

Find a Type 1 Trial Near You

WRITTEN BY BT1 Editorial Team, POSTED 03/23/20, UPDATED 07/25/23

This piece was authored collaboratively by the Beyond Type 1 Editorial Team.