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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Allogeneic pancreatic endocrine cell clusters
Biological/VaccineAllogeneic pancreatic endocrine cell clusters
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: SR-02 allogeneic pancreatic endocrine cell clustersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To investigate the safety and tolerability of SR-02 when implanted in subjects with T1D and Level 3 hypoglycemia as assessed by CIT-TCAE v5.0.
Safety variables include the percentage, severity, and relatedness of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) from the SR-02 implant to Day 365.
Time frame
Day 35 to Day 3652
Change in C-peptide secretion from baseline.
Outcome will be measured by mixed-meal tolerance test (MMTT)-stimulated C peptide at 3-month intervals.
Time frame
Enrollment to Day 365Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: