A Phase 1 interventional study of VCTX211 in Diabetes Mellitus, Diabetes Mellitus, Type 1 and Glucose Metabolism Disorders, sponsored by CRISPR Therapeutics AG. Terminated at 2 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by CRISPR Therapeutics AG · Phase 1, Interventional, and Treatment
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →CRISPR Therapeutics AG is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Compared within Diabetes Mellitus, Type 1, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: VCTX211
CRISPR-Cas9 genetically modified PEC211 cells loaded into a delivery device
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.
Time frame: From implantation up to 12 months post implantation
Assess the clinical efficacy of VCTX211 units via evaluation of C-peptide increase from the baseline.
Time frame: From implantation up to 12 months post implantation
Incidence of adverse events reported in patients implanted with VCTX211 units.
Time frame: 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.
Time frame: From implantation up to 12 months post implantation
Assess the clinical efficacy of VCTX211 units via evaluation of changes in number of hypoglycemic evens from baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From implantation up to 12 months post implantation
Incidence of new alloreactive antibodies found in the blood of patients post implantation.
Time frame: From implantation up to 12 months post implantation
Incidence of new autoreactive antibodies found in the blood of patients post implantation.
Time frame: From implantation up to 12 months post implantation
The percentage of viable graft cells per unit using immunohistochemical staining.
Time frame: 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.
Time frame: From implantation up to 12 months post implantation
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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CRISPR Therapeutics AG