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NOT YET RECRUITING
NCT07581197
PHASE1/PHASE2

Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes

Sponsor: Seraxis

View on ClinicalTrials.gov

Summary

This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.

Official title: A Phase 1/2 Dose Escalation Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes (SUGR)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2026-11

Completion Date

2029-11

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Allogeneic pancreatic endocrine cell clusters

Allogeneic pancreatic endocrine cell clusters