Actively Recruiting
Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
Led by Hangzhou Reprogenix Bioscience, Inc · Updated on 2025-09-15
10
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years old, male or female
- Diagnosis of Type 1 diabetes mellitus, including those who had organ transplants like liver or kidney
- Stimulated C-peptide level less than 0.3 ng/mL
- At least one severe hypoglycemic episode in the 12 months before joining the study
You will not qualify if you...
- Diagnosis of Type 2 diabetes mellitus
- Untreated proliferative diabetic retinopathy
- Serious heart disease
- Serious gastrointestinal dysfunction
- Serious psychological diseases
- Any history of cancer
- History of tobacco, alcohol, or drug abuse
- For females: positive pregnancy test, breastfeeding, or unwillingness to use effective contraception during the study
- For males: intent to father a child or unwillingness to use effective contraception during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
Research Team
L
Linlin Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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