Study Stopped
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A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia
SUGR
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
1 other identifier
interventional
N/A
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2025
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
October 16, 2025
October 1, 2025
1.9 years
October 16, 2024
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To investigate the safety and tolerability based on the percentage and relatedness of all treatment emergent adverse events and serious adverse events (TEAEs and SAEs)
day 35 through day 365
The effect on endogenous insulin secretion as assessed by 90-minute MMTT-stimulated C-peptide >0.5 ng/ml (>0.17 nmol/L)
90 day intervals through day 365
Study Arms (1)
SR-02 Allogeneic pancreatic endocrine cell clusters
EXPERIMENTALInterventions
Allogeneic Pancreatic Endocrine Cell Clusters
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seraxislead
Study Sites (2)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2024
First Posted
October 21, 2024
Study Start
April 1, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
October 16, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share