RecruitingPhase 1NCT06731218

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

Sponsor

Hangzhou Reprogenix Bioscience, Inc

Enrollment

10 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

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

Exclusion Criteria8

Type 2 diabetes patients;
Untreated proliferative diabetes retinopathy;
Serious heart disease;
Serious gastrointestinal dysfunction ；
Serious psychological diseases；
Any history of malignancy;
Have a history of tobacco, alcohol and drug abuse;
For female subjects: pregnancy test positive, lactation or unwilling to use effective contraceptive measures during the study period, male patients: intent to procreate or unwilling to use effective contraceptive measures during the study period.