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 |
|
| Source weblink |
https://clinicaltrials.gov/ct2/show/NCT04678557 |
| Regulatory body approval |
| Name |
Food and Drug Administration (FDA) |
| Country |
|
|
| Public contact |
| Email |
info@viacyte.com |
| Public email |
info@viacyte.com |
| Country |
|
|
| Sponsors |
ViaCyte
|
Cells |
| 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 |
Terminated |
| Comment recruitment status |
Terminated (Insufficient functional product engraftment) |
| Estimated number of participants |
31 |
