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
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Age: 18-60 years old (including 18 and 60 years old), male and female;
• Type 1 diabetes patients (including those who have received organ transplantation such as liver and kidney);
• Stimulated C-peptide \< 0.3 ng/mL;
• The patient had at least one severe hypoglycemia within 12 months before being included in the project
Locations
Other Locations
China
Tianjin First Center Hospital
RECRUITING
Tianjin
Contact Information
Primary
Linlin Jiang
Linlin.jiang@reprogenix.com
+86+571-88601920
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 10
Treatments
Experimental: RGB-5088
Transplantation under the anterior rectus sheath
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Reprogenix Bioscience, Inc