NCT07581197

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

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
37mo left

Started Nov 2026

Typical duration for phase_1

Status
not yet recruiting

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

May 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 1, 2026

Last Update Submit

May 6, 2026

Conditions

Diabete MellitusDiabete Type 1

Keywords

Severe hypoglycemia

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 35 to Day 365

  • Change in C-peptide secretion from baseline.

    Outcome will be measured by mixed-meal tolerance test (MMTT)-stimulated C peptide at 3-month intervals.

    Enrollment to Day 365

Study Arms (1)

SR-02 allogeneic pancreatic endocrine cell clusters

EXPERIMENTAL
Biological: Allogeneic pancreatic endocrine cell clusters

Interventions

Allogeneic pancreatic endocrine cell clustersBIOLOGICAL

Allogeneic pancreatic endocrine cell clusters

SR-02 allogeneic pancreatic endocrine cell clusters

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Director of Clinical Operations

CONTACT

240-308-8681info@seraxis.com

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

May 1, 2026

First Posted

May 12, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2029

Last Updated

May 12, 2026

Record last verified: 2026-05