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

Hangzhou Reprogenix Bioscience, Inc

Status and phase

Enrolling

Phase 1

Conditions

Diabetes Mellitus, Type 1

Diabetes Mellitus

Treatments

Biological: RGB-5088

Study type

Interventional

Funder types

Industry

Identifiers

NCT06731218

RGB-5088-01

Details and patient eligibility

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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.