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| Name | Class |
|---|---|
| ViaCyte | INDUSTRY |
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This is an open-label, multicenter, Phase 1 study evaluating the safety and tolerability of VCTX210A combination product in patients with T1D
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCTX210A combination product | Experimental | Up to seven (7) units will be implanted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCTX210A unit | Combination Product | CRISPR-Cas9 genetically modified PEC210A cells loaded into a delivery device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Qualitative evaluation of immune response to VCTX210A units assessed by histological staining for markers of host adaptive immune cells within the graft. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Manasi Jaiman, MD, MPH | ViaCyte | Study Director |
| Sandeep Soni, MD | CRISPR Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | Canada | |||
| University of British Columbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42023429 | Derived | Lin TM, Chang HF, Lin TC, Lin CH, Sun YL, Lin CS. Gene Therapy and Gene Editing in Type 1 Diabetes: CRISPR-Based beta-Cell Replacement and Treg Immune Modulation Approaches. Diabetes Obes Metab. 2026 Jul;28(7):5476-5491. doi: 10.1111/dom.70800. Epub 2026 Apr 23. | |
| 37528526 | Derived | Ellis CE, Mojibian M, Ida S, Fung VCW, Skovso S, McIver E, O'Dwyer S, Webber TD, Braam MJS, Saber N, Sasaki S, Lynn FC, Kieffer TJ, Levings MK. Human A2-CAR T Cells Reject HLA-A2 + Human Islets Transplanted Into Mice Without Inducing Graft-versus-host Disease. Transplantation. 2023 Sep 1;107(9):e222-e233. doi: 10.1097/TP.0000000000004709. Epub 2023 Aug 21. |
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| From implantation up to 6 months post implantation |
| Incidence of new alloreactive antibodies found in the blood of patients post implantation. | From implantation up to 6 months post implantation |
| Incidence of new autoreactive antibodies found in the blood of patients post implantation. | From implantation up to 6 months post implantation |
| The percentage of viable graft cells per unit using immunohistochemical staining. | From implantation up to 6 months post implantation |
| 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 |
| Vancouver |
| British Columbia |
| Canada |
| LMC Manna | Toronto | Ontario | Canada |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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