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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05210530
Other study ID # VCTX210A-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 24, 2022
Est. completion date January 19, 2023

Study information

Verified date June 2023
Source CRISPR Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date January 19, 2023
Est. primary completion date January 19, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Combination Product:
VCTX210A unit
CRISPR-Cas9 genetically modified PEC210A cells loaded into a delivery device

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta
Canada LMC Manna Toronto Ontario
Canada University of British Columbia Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
CRISPR Therapeutics AG ViaCyte

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events with causality related to VCTX210A units and/or the surgical procedures required to implant and explant the VCTX210A units. From implantation up to 6 months post implantation
Secondary Qualitative evaluation of immune response to VCTX210A units assessed by histological staining for markers of host innate immune cells within the graft. From implantation up to 6 months post implantation
Secondary Qualitative evaluation of immune response to VCTX210A units assessed by histological staining for markers of host adaptive immune cells within the graft. From implantation up to 6 months post implantation
Secondary Incidence of new alloreactive antibodies found in the blood of patients post implantation. From implantation up to 6 months post implantation
Secondary Incidence of new autoreactive antibodies found in the blood of patients post implantation. From implantation up to 6 months post implantation
Secondary The percentage of viable graft cells per unit using immunohistochemical staining. From implantation up to 6 months post implantation
Secondary The percentage of graft cells per unit that have differentiated into endocrine/beta cells as determined by immunohistochemical staining. From implantation up to 6 months post implantation
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