Celregen CRG-002 allogeneic iPSC-derived islets
Exploratory early-phase study of allogeneic iPSC-derived pancreatic islet cells given by portal-vein infusion or anterior rectus sheath transplantation in diabetes with hypoglycemia unawareness or severe events. The registry is enrolling by invitation; a conference abstract reports only the first participant through six months.
Primary endpoints
- Safety assessed by adverse events according to CTCAE v6.0
Results so far
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.