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

Description

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.

Conditions

Diabetes Mellitus Type 1

Study Overview

Study Details

Study overview

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.

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

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

Condition
Diabetes Mellitus Type 1
Intervention / Treatment

-

Contacts and Locations

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Pittsburgh

UPMC Presbyterian Shadyside, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to 65 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Seraxis,

    Study Record Dates

    2028-03