Status:
COMPLETED
An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1D
Lead Sponsor:
CRISPR Therapeutics AG
Collaborating Sponsors:
ViaCyte
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, Phase 1 study evaluating the safety and tolerability of VCTX210A combination product in patients with T1D
Detailed Description
VCTX210A combination product (unit) comprises 2 components: (1) allogeneic pancreatic endoderm cells (PEC210A) genetically modified using Clustered Regularly Interspaced Short Palindromic Repeats/CRIS...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Diagnosis of T1D for a minimum of 5 years
- Stable, optimized diabetic regimen for at least 3 months prior to enrollment
- Exclusion Criteria
- Medical history of islet cell, kidney, and/or pancreas transplant
- Occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment
- Known causes of diabetes other than T1D
- Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study
- Prior treatment with gene therapy or edited product
Exclusion
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05210530
Start Date
January 24 2022
End Date
January 19 2023
Last Update
June 26 2023
Active Locations (3)
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1
University of Alberta
Edmonton, Alberta, Canada
2
University of British Columbia
Vancouver, British Columbia, Canada
3
LMC Manna
Toronto, Ontario, Canada