Implanting pancreatic cell clusters to treat severe hypoglycemia in type 1 diabetes
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
This study is testing if implanting pancreatic cell clusters can help people with type 1 diabetes who have severe low blood sugar episodes feel better and stay safe.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Seraxis Industry-sponsored |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT06651515 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of implanting allogeneic pancreatic endocrine cell clusters into the omentum of patients with type 1 diabetes who experience severe recurrent hypoglycemia. It aims to determine the optimal treatment dose while requiring immunosuppression to prevent rejection of the implanted cells. Participants will be monitored for safety and efficacy outcomes, contributing to the understanding of this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a long-standing diagnosis of type 1 diabetes and a history of recurrent severe hypoglycemia.
Not a fit: Patients who are using anti-diabetic agents other than insulin or have recently used weight loss medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of severe hypoglycemia in patients with type 1 diabetes.
How similar studies have performed: While this approach is novel, similar studies involving cell transplantation for diabetes management have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria * Adult 18 to 65 years with a clinical history of T1D * Diagnosis of T1D at \<40 years of age * insulin dependence for ≥5 years at pre-screening * Recurrent severe hypoglycemia * Willingness to use continuous glucose monitoring Key Exclusion Criteria * Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening * Weight loss medication(s) within 3 months of Screening Other protocol defined Inclusion/Exclusion criteria may apply
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- UPMC Presbyterian Shadyside — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Mohammad Razvi
- Email: clinicaltrials@seraxis.com
- Phone: 240-308-8681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.