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NCT07581197Not yet recruitingPhase 1/2

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)

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
9 (estimated)
First submitted
1 May 2026
Start date
Nov 2026
Primary completion date
Nov 2028
Lead sponsor
Seraxis
NCT number
NCT07581197

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 9
  • From Nov 2026 to the primary completion date, Nov 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Weight loss medication(s) within 3 months of Screening
    • Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.