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Phase 1/2Not yet recruitingNCT07581197

Seraxis SR-02 pancreatic endocrine cells in adult T1D

What this study tests

First-in-human Seraxis phase 1/2 study of allogeneic pancreatic endocrine cell clusters implanted into the omentum of adults with type 1 diabetes and severe recurrent hypoglycemia. The initial SR-02 study still requires immunosuppression.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-05-12.

Most recent recorded citation date: 2026-05-12. 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

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults aged 18-65 with type 1 diabetes and level 3 hypoglycemia. 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 posted yet.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 are not specified here. 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.

Primary endpoints

  • Safety and tolerability of SR-02 from day 35 to day 365
  • Change in C-peptide secretion from enrollment to day 365

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. [1]