VCTX211: CRISPR gene-edited hypoimmune stem-cell islets
What this study tests
Phase 1 study of gene-edited pancreatic cells in a removable implant. The terminated study enrolled five participants. An August 2026 company presentation reports 12-month C-peptide, histologic cell survival and no serious adverse events; full registry results are not posted. These are CTX211 findings, not human evidence for its preclinical successor CTX213.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-05-07.
Most recent recorded citation date: 2026-08-03. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults 18-65 with type 1 diabetes diagnosed at least 5 years ago and on a stable diabetes regimen for at least 3 months. Excluded if they had a prior islet/kidney/pancreas transplant, two or more severe unexplained low-blood-sugar events in the past 6 months, recent immunosuppressant use, or prior gene therapy. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results are posted to ClinicalTrials.gov. The 3 August 2026 company presentation reports CTX211 C-peptide production at 12 months, no serious adverse events or adverse events of special interest, and histologic survival of insulin-producing graft cells despite device fibrosis and immune-cell infiltration. These sponsor-reported observations do not establish insulin independence, long-term safety or CTX213 efficacy. The registry records five enrolled participants and termination for follow-up in VCTX-201; it does not confirm that every participant was dosed or contributed to each reported observation.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Primary endpoints
- Incidence of adverse events related to VCTX211, the implant procedure, and study interventions (safety/tolerability)
- Change from baseline in C-peptide, a marker of the implanted cells producing insulin
The full picture
What was tested
VCTX211/CTX211 placed gene-edited, stem-cell-derived pancreatic cells in a removable implant. The edits were intended to improve immune evasion and cell survival without anti-rejection medication. This was a single-group Phase 1 safety study in Canadian adults with established type 1 diabetes.1
Registry status and population
The registry records five enrolled participants and termination, citing transfer to long-term follow-up in VCTX-201. Enrolment does not confirm that every participant received a dose or contributed to every reported observation. No registry results are posted. The protocol's exclusion of chronic immunosuppression is an eligibility criterion, not documentation of each participant's full medication course.1
What the company has reported
In January 2026, CRISPR Therapeutics reported detectable C-peptide at 12 months and a transition to CTX213 development.2 Its 3 August 2026 corporate presentation, slide 41, adds that CTX211 had no serious adverse events or adverse events of special interest, and that histology showed survival of transplanted insulin-producing cells despite fibrosis around the device and immune-cell infiltration.3
These findings are company-reported clinical context. They are more detailed than the January announcement but are not a full peer-reviewed or registry-posted clinical dataset. Detectable C-peptide is not insulin independence; the reported absence of serious events in this small study cannot establish long-term safety. The company's description of Phase 1 as completed does not change the registry's formal terminated status.13
Distinction from CTX213
CTX213 is a device-free successor. The same presentation describes its preclinical findings in a chemically induced diabetic rat model. CTX211 human experience does not establish CTX213 clinical efficacy, safety, durability or freedom from immunosuppression. The linked programme item scores the current preclinical CTX213 candidate and retains this trial as predecessor context.3
Sources
- [1]NCT05565248: study record · Trial registry — Current status, study design and eligibility checked 16 September 2026; this does not imply posted outcomes.
ClinicalTrials.gov, NCT05565248.
- [2]CRISPR Therapeutics: January 2026 priorities and CTX211 update · Manufacturer
CRISPR Therapeutics, January 12, 2026 company update filed with the SEC.
- [3]CRISPR Therapeutics corporate update, 3 August 2026 — CTX211/CTX213, slide 41 · Manufacturer · 2026-08-03 — Company presentation, not peer-reviewed clinical results. CTX211 human observations are separate from CTX213 animal findings.
CRISPR Therapeutics corporate update, 3 August 2026, slide 41.