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Patients to be followed up in the VCTX-201 study
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| Name | Class |
|---|---|
| ViaCyte | INDUSTRY |
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This is an open-label, multicenter, Phase 1 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D
VCTX211 combination product (unit) compromises 2 components: (1) allogeneic pancreatic endoderm cells (PEC211) genetically modified using Cluster 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 PEC211 cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCTX211 unit | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCTX211 | Combination Product | CRISPR-Cas9 genetically modified PEC211 cells loaded into a delivery device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events with causality related to VCTX211 units, the surgical procedures and/or medical interventions required to implant and explant the VCTX211 units. | From implantation up to 12 months post implantation | |
| Assess the clinical efficacy of VCTX211 units via evaluation of C-peptide increase from the baseline. | From implantation up to 12 months post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events reported in patients implanted with VCTX211 units. | From implantation up to 12 months post implantation | |
| Assess the clinical efficacy of VCTX211 units via evaluation of changes in exogenous insulin use from baseline. | From implantation up to 12 months post implantation |
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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. |
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| Assess the clinical efficacy of VCTX211 units via evaluation of changes in number of hypoglycemic evens from baseline. | From implantation up to 12 months post implantation |
| Assess the clinical efficacy of VCTX211 units via evaluation of changes in hemoglobin A1C levels from baseline. | From implantation up to 12 months post implantation |
| Assess the clinical efficacy of VCTX211 units via evaluation of percentage of time in pre-defined glycemic ranges, as measured by a continuous glucose monitor, from baseline. | From implantation up to 12 months post implantation |
| Qualitative evaluation of immune response to VCTX211 units assessed by histological staining for markers of host adaptive immune cells within the graft. | From implantation up to 12 months post implantation |
| Incidence of new alloreactive antibodies found in the blood of patients post implantation. | From implantation up to 12 months post implantation |
| Incidence of new autoreactive antibodies found in the blood of patients post implantation. | From implantation up to 12 months post implantation |
| The percentage of viable graft cells per unit using immunohistochemical staining. | From implantation up to 12 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 12 months post implantation |
| Vancouver |
| British Columbia |
| 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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