A Study to Evaluate Safety, Engraftment, and Efficacy of VC-01 in Subjects With T1 Diabetes Mellitus (VC01-103)

General Information

Summary VC01-103 will evaluate an experimental combination product, cell replacement therapy intended to provide a functional cure to subjects with Type 1 Diabetes.
Description This trial will test if VC-01 combination product can be implanted and maintained with safety, tolerability, and efficacy for up to Month 12/Week 52.
Clinical trials phase Phases 1/2
Start date (estimated) 2019-06-25
End date (estimated) 2019-11-19
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 NCT04678557
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04678557
Other study identifiers
Name VC01-103
Source weblink https://clinicaltrials.gov/ct2/show/NCT04678557
Regulatory body approval
Name Food and Drug Administration (FDA)
United States
Public contact
Email info@viacyte.com
Public email info@viacyte.com
United States
Sponsors ViaCyte


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 Terminated
Comment recruitment status Terminated (Insufficient functional product engraftment)
Estimated number of participants 31