WITHDRAWN

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-04
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT06651515

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Seraxis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2028-03

Study Record Updates

Study Start Date2025-04
Study Completion Date2028-03

Terms related to this study

Keywords Provided by Researchers

  • severe hypoglycemia
  • diabetes mellitus
  • endocrine system diseases
  • glucose metabolism disorders

Additional Relevant MeSH Terms

  • Diabetes Mellitus Type 1