WithdrawnPhase 1/2

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

Stopped: Study is being withdrawn for business reasons

United States0Started 2025-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

Timeframe: 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)

Timeframe: 90 day intervals through day 365

Trial details

NCT IDNCT06651515

SponsorSeraxis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

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