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

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 maintained safely for up to four (4) months.
Description Not Provided
Clinical trials phase Phase 1
Start date (estimated) 2017-07-05
End date (estimated) 2018-02-15
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 NCT03162926
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03162926
Other study identifiers
Name VC02-102
Source weblink https://clinicaltrials.gov/ct2/show/study/NCT03162926
Regulatory body approval
Name Food and Drug Administration (FDA)
Country
United States
Sponsors ViaCyte

Cells

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

Recruitment Status Completed
Estimated number of participants 3