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

ClinicalTrials.gov ID: NCT06651515

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Official title

A Phase 1/2 Adaptive Dose Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06651515
Recruitment status: Withdrawn
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Seraxis; Industry
Enrollment: Not listed

Conditions and interventions

Conditions

Diabetes Mellitus Type 1

Interventions

Allogeneic Pancreatic Endocrine Cell Clusters Biological

Biological

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 2025 (Estimated)
Primary completion: Mar 2027 (Estimated)
Completion: Mar 2028 (Estimated)
Last update posted: Oct 16, 2025

2025 – 2028

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 2

Facility	City	State	ZIP	Site status
University of Pennsylvania	Philadelphia	Pennsylvania	19104	—
UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania	15213	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06651515, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 16, 2025 · Synced Nov 14, 2026