Celregen CRG-002 iPSC-derived islets
Celregen Therapeutics
Promising first recipient, far too early to generalize.
What it is
Allogeneic iPSC-derived pancreatic islet cells in an invitation-only Chinese phase 1 study. A conference abstract (cited; text not retrievable in-session) reports that the first recipient became insulin-independent by day 110, but this is one person followed for only six months while receiving a glucocorticoid-free immunosuppressive regimen.
Editorial review: .
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 behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Insulin independence: The first reported recipient achieved complete insulin independence on day 110, but n=1 cannot establish a response rate.[2]
- Important harms and treatment burden
- Immunosuppression-free: The first participant received a glucocorticoid-free immunosuppressive regimen; glucocorticoid-free does not mean immunosuppression-free.[2]
- Approval and country access
- Invitation-only phase 1 study; no peer-reviewed participant series found in PubMed under the exact-phrase query checkedApproval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Six months of follow-up is an early function signal, not evidence of durable multi-year graft survival.[2]
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.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 35 × 30 + 18 × 20 + 12 × 20 + 45 × 10 + 15 × 10 + 25 × 10 = 2500; divide by total weight 100. Unrounded weighted result: 25.
The first reported recipient achieved complete insulin independence on day 110, but n=1 cannot establish a response rate.[2]
Six months of follow-up is an early function signal, not evidence of durable multi-year graft survival.[2]
The first participant received a glucocorticoid-free immunosuppressive regimen; glucocorticoid-free does not mean immunosuppression-free.[2]
Administration is by portal-vein infusion or transplantation beneath the anterior rectus sheath, less burdensome than major surgery but still procedural.[1]
Early study is small and limited to severe-hypoglycemia/hypoglycemia-unawareness populations.[1]
A phase 1 study is enrolling 10 people by invitation and has reported only its first participant in a cited conference abstract (abstract text not retrievable in-session), not a peer-reviewed paper or registry results posting.[2]
The full picture
CRG-002 belongs in the same broad race as zimislecel, SR-02 and other manufactured islet sources: make enough functional islets for transplantation without relying on scarce deceased-donor pancreases. The phase 1 registry plans 10 adults aged 18-70 with T1D or pancreatogenic diabetes and severe hypoglycemia/hypoglycemia unawareness, and describes portal-vein infusion or placement beneath the anterior rectus sheath.1 Its live status is enrolling by invitation, which this site's coarser trial taxonomy displays as recruiting.1
What the first-participant abstract reports
An EASD 2026 conference abstract reports six-month follow-up for the first recipient after one intraportal CRG-002 infusion and a glucocorticoid-free immunosuppressive regimen.2 At baseline, time in range was 33.9%, HbA1c was 9.4%, daily insulin was 27 IU, fasting C-peptide was undetectable below 0.5 ng/mL, and stimulated C-peptide was 0.13 ng/mL.2
The abstract reports time in range above 70% by day 30 and 96.9% at week 24, HbA1c falling to 6.9% at week 12 and 6.0% at week 16, and complete insulin independence achieved on day 110.2 At week 24, fasting and stimulated C-peptide were 0.88 and 2.84 ng/mL. It reports no acute rejection, portal-vein thrombosis, instant blood-mediated inflammatory reaction or thrombotic microangiopathy; possibly treatment-related events were grade 1-2 hypoglycemia.2
The evidence boundary
This is a meaningful participant-level proof-of-function signal, not a cure claim. It is one person, six months, in a conference abstract whose presentation is scheduled for 29 September 2026. There is no peer-reviewed participant series and no results posting on the trial registry. A response in one selected recipient gives no response rate, and six months cannot establish durability.
The immune caveat is equally important. The regimen was glucocorticoid-free, not immunosuppression-free.2 CRG-002 therefore does not yet solve the systemic immune-management barrier that keeps cell replacement from broad T1D use. The next evidence to watch is whether more of the planned 10 participants reproduce the result, with transparent adverse events and follow-up measured in years rather than months.
Coming soon
ETA · Phase 1 enrolling by invitation; cited abstract data cover only n=1 with six months of follow-up (abstract text not retrievable in-session), with primary completion estimated January 2028
- →Full EASD presentation of the first-participant result · 29 September 2026
- →Results beyond the first participant and beyond six months described in the cited abstract · No public readout date found in the checked registry and PubMed sources; registry completion estimated January 2028
Sources
- [1]CRG-002 allogeneic iPSC-derived pancreatic islet cells (NCT07503028) · Trial registry — Enrolling by invitation, n=10, with primary completion estimated 18 January 2028; live-checked 27 August 2026 (last registry update 26 August 2026).
ClinicalTrials.gov. CRG-002 allogeneic iPSC-derived pancreatic islet cells (NCT07503028). Enrolling by invitation; 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 page resolves (abstract text not retrievable in-session); accessed 8 August 2026 as cited; presentation in the EASD late-breaking session. Conference abstract only, reported as one participant and six months of follow-up.
Sun B, et al. First-in-human transplantation of CRG-002, an iPSC-derived universal islet product for type 1 diabetes. EASD 2026 conference abstract (page resolves; abstract text not retrievable in-session), accessed 8 August 2026 as cited; presentation in the EASD late-breaking session.