A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia
Megadott ok: Study is being withdrawn for business reasons
Key facts
- Where
- Philadelphia és Pittsburgh, Egyesült ÁllamokSee the 2 sites
- Phase
- 1/2. fázis
Where in Egyesült Államok
- University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- UPMC Presbyterian ShadysidePittsburgh, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Seraxis
- Trial code
- NCT06651515
- Record updated
- 2025. október 16.
- Original 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.Read full original descriptionShow less
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 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: Weight loss medication(s) within 3 months of Screening; Other protocol defined Inclusion/Exclusion criteria may apply; Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening.