Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes

A Phase 1/2 Dose Escalation Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes (SUGR)

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07581197

Enrollment

Registered

2026-05-12

Start date

2026-11-01

Completion date

2029-11-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Mellitus, Diabete Type 1

Keywords

Severe hypoglycemia

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.

Interventions

BIOLOGICALAllogeneic pancreatic endocrine cell clusters

Allogeneic pancreatic endocrine cell clusters

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria * 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 Key

Exclusion criteria

* 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/

Design outcomes

Primary

Measure	Time frame	Description
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.	Day 35 to Day 365	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.
Change in C-peptide secretion from baseline.	Enrollment to Day 365	Outcome will be measured by mixed-meal tolerance test (MMTT)-stimulated C peptide at 3-month intervals.

Contacts

CONTACTDirector of Clinical Operations

info@seraxis.com240-308-8681

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026