An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1D

General Information

Summary This is an open-label, multicenter, Phase 1 study evaluating the safety and tolerability of VCTX210A combination product in patients with T1D
Description VCTX210A combination product (unit) comprises 2 components: (1) allogeneic pancreatic endoderm cells (PEC210A) genetically modified using Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9 (CRISPR/Cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain the PEC210A cells.
Clinical trials phase Phase 1
Start date (estimated) 2022-01-24
End date (estimated) 2023-01-19
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 NCT05210530
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05210530
Other study identifiers
Name VCTX210A-101
Source weblink https://clinicaltrials.gov/ct2/show/NCT05210530
Public contact
Email MedicalAffairs@crisprtx.com
Public email MedicalAffairs@crisprtx.com
Last name Clinical Trials
Phone +1 (877) 214-4634
Country
United States
Sponsors ViaCyte
CRISPR Therapeutics AG

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 7