Celregen CRG-002 allogeneic iPSC-derived islets
What this study tests
Exploratory early-phase study of allogeneic iPSC-derived pancreatic islet cells given by portal-vein infusion or anterior rectus sheath transplantation in type 1 or pancreatogenic diabetes with hypoglycemia unawareness or severe hypoglycemic events. The registry is enrolling by invitation; a conference abstract reports only the first participant through six months.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-08-26.
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 18-70 with type 1 diabetes or pancreatogenic diabetes and hypoglycemia unawareness or severe hypoglycemic events. 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 registry results are posted. An EASD 2026 conference abstract reports one participant after a single intraportal infusion plus a glucocorticoid-free immunosuppressive regimen: complete insulin independence achieved on day 110, HbA1c reaching 6.0% at week 16, and 96.9% time in range at week 24, with fasting/stimulated C-peptide of 0.88/2.84 ng/mL. No acute rejection, portal-vein thrombosis, instant blood-mediated inflammatory reaction or thrombotic microangiopathy was reported; possibly related events were grade 1-2 hypoglycemia. This is n=1, six-month, conference-abstract evidence—not a response rate, durable result, peer-reviewed series or immunosuppression-free cure.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: Other regions. 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 assessed by adverse events according to CTCAE v6.0
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT07503028: Celregen CRG-002 allogeneic iPSC-derived islets · Trial registry — Enrolling by invitation, n=10, with primary completion estimated 18 January 2028; accessed 8 August 2026.
- [2]First-in-human transplantation of CRG-002, an iPSC-derived universal islet product for type 1 diabetes · Conference finding — EASD 2026 abstract publicly available and accessed 8 August 2026; presentation scheduled for 29 September 2026. One participant with six months of follow-up.