VC-01: ViaCyte first-gen encapsulated stem-cell islets
What this study tests
Early trial of stem-cell-derived pancreatic progenitors inside an immune-protective implant, without anti-rejection drugs. The study enrolled 19 people and was terminated for insufficient functional engraftment. Funder and sponsor reports describe a foreign-body response that limited cell survival and engraftment; some implanted cells survived and matured, but a clinically effective replacement therapy was not established.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2022-03-24.
Source dates appear in the references where available; this record has no dated citation metadata.
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 aged 18-55 with type 1 diabetes for at least 3 years, on stable diabetes treatment. People with advanced diabetes complications or already taking immune-suppressing drugs were excluded. 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
- The registry gives insufficient functional product engraftment as the reason for termination. CIRM reported that a foreign-body response limited engraftment in some cases, while surviving cells could differentiate into islet cells. The sponsor reported survival in some implants for up to two years. Preliminary reports found no evidence of immune sensitization or off-target growth, but this small study does not establish long-term safety or effective insulin replacement.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: United States, 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
- Safety and tolerability: number of adverse events through the Month 24 visit
- Efficacy: change in C-peptide (a marker of the implant's own insulin production) from baseline to Month 6
The full picture
What was tested
VC-01 placed stem-cell-derived pancreatic progenitors inside an immune-protective device under the skin, without anti-rejection drugs. The open-label Phase 1/2 study enrolled 19 adults. Safety and C-peptide production were its main outcomes.1
What was learned
The registry records termination for insufficient functional engraftment. CIRM's preliminary report describes a foreign-body response that limited engraftment in some cases. Surviving cells could differentiate into islet cells, and ViaCyte reported survival in some implants for up to two years.123 These findings do not demonstrate reliable insulin replacement.
The tissue response around the implant was an important limitation. Preliminary observations of immune protection and absence of off-target growth do not establish long-term safety.23
Sources
- [1]NCT02239354: study record · Trial registry — Current status, study design and eligibility checked 16 September 2026; this does not imply posted outcomes.
ClinicalTrials.gov, NCT02239354.
- [2]CIRM: VC-01 clinical trial Year 4 progress report · Open-source community — Primary funder report; preliminary observations, not a controlled efficacy publication.
- [3]ViaCyte: two-year STEP ONE data presented at ADA 2018 · Manufacturer
ViaCyte, two-year STEP ONE data presented at ADA 2018 (company report).