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

General Information

Summary The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.
Clinical trials phase Phases 1/2
Start date (estimated) 2017-07-06
End date (estimated) 2023-10-19
Clinical feature
Label type 1 diabetes mellitus
Link http://purl.obolibrary.org/obo/DOID_9744
Description A diabetes mellitus that is characterized by destruction of pancreatic beta cells resulting in absent or extremely low insulin production.; Xref MGI. OMIM mapping confirmed by DO. [SN].

Administrative Information

NCT number NCT03163511
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03163511
Other study identifiers
Name VC02-101
Source weblink https://clinicaltrials.gov/ct2/show/NCT03163511
Public contact
Email info@viacyte.com
Public email info@viacyte.com
United States
Sponsors ViaCyte


Source pluripotent stem cell lines
Which differentiated cell type is used
Label progenitor cell of endocrine pancreas
Link http://purl.obolibrary.org/obo/CL_0002351
Description A progenitor cell that is able to differentiate into the pancreas alpha, beta and delta endocrine cells. This cell type expresses neurogenin-3 and Isl-1.


Recruitment Status Completed
Estimated number of participants 49