Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSeraxis
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Allogeneic pancreatic endocrine cell clusters
Treatment groups
9 Participants
are divided into 1 treatment groupLocations
This trial has no locations
Sponsors and collaborators
Seraxis
Lead sponsor
Source ClinicalTrials.gov