NCT06731218

Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus

A Single-Center, Single-Arm, Open-Label Phase I Clinical Trial Evaluating the Safety and Efficacy of RGB-5088 Islet Cell Injection in the Treatment of Type 1 Diabetes Mellitus

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hangzhou Reprogenix Bioscience, Inc · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
BIOLOGICAL	RGB-5088	Transplantation under the anterior rectus sheath

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-12-31
• Completion: 2031-12-31
• First posted: 2024-12-12
• Last updated: 2025-09-15

Locations

1 site across 1 country: China