A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness
Written by: Beyond Type 1 Editorial Team
2 minute read
March 23, 2020
Learn about the phase 1 + 2 clinical trial by ViaCyte testing its VC-02 device implant for safety and effectiveness over two years.
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
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Stay tuned for in-depth coverage from Beyond Type 1 on the results of this study. To learn more about this trial click here
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Beyond Type 1 Editorial Team
Beyond Type 1 is the largest diabetes org online, funding advocacy, education and cure research. Find industry news, inspirational stories and practical help. Join the 1M+ strong community and discover what it means to #LiveBeyond a diabetes diagnosis.
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