NCT07581197
Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
Not Yet Recruiting · Phase 1, Phase 2 · Seraxis · registry updated 2026-10-19
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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
Exclusion
- 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.