drugset / Trial / NCT06651515

A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia

NCT06651515 ↗

Phase 1/2 Withdrawn Seraxis
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-04
Primary completion
2027-03
Completion
2028-03

Outcome

Outcome not reported

Stopped (Business): “Study is being withdrawn for business reasons”

Drugs

EvaluationDrugModalityDoseRoute
Subject SR-02 Cell therapy — Other