A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2028-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SR-02 Allogeneic pancreatic endocrine cell clusters

Group Type EXPERIMENTAL

Allogeneic Pancreatic Endocrine Cell Clusters

Intervention Type BIOLOGICAL

Allogeneic Pancreatic Endocrine Cell Clusters

Interventions

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Allogeneic Pancreatic Endocrine Cell Clusters

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No