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)

Seraxis

Status and phase: Begins enrollment in 1 month; Phase 2; Phase 1

Conditions: Diabetes Mellitus Type 1

Treatments: Biological: Allogeneic Pancreatic Endocrine Cell Clusters

Study type: Interventional

Funder types: Industry

Identifiers

NCT06651515

SR-02-201

Details and patient eligibility

About

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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

SR-02 Allogeneic pancreatic endocrine cell clusters

Experimental group

Treatment:

Biological: Allogeneic Pancreatic Endocrine Cell Clusters