Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
NCT06731218 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-09-15
Summary
This Phase I clinical trial is a single-center, single-arm, open-label study aimed at evaluating the safety and therapeutic efficacy of RGB-5088 islet cell transplantation in patients with Type 1 Diabetes Mellitus.
Conditions
- Diabetes Mellitus, Type 1
- Diabetes Mellitus
Interventions
- BIOLOGICAL
-
RGB-5088
Transplantation under the anterior rectus sheath
Sponsors & Collaborators
-
Hangzhou Reprogenix Bioscience, Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-17
- Primary Completion
- 2027-12-31
- Completion
- 2031-12-31
Countries
- China
Study Locations
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