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

Hangzhou Reprogenix Bioscience, Inc1 site in 1 country10 target enrollmentFebruary 17, 2025

ConditionsDiabetes Mellitus, Type 1 Diabetes Mellitus

InterventionsRGB-5088

DrugsRGB-5088

Overview

Phase: Phase 1
Intervention: RGB-5088
Conditions: Diabetes Mellitus, Type 1
Sponsor: Hangzhou Reprogenix Bioscience, Inc
Enrollment: 10
Locations: 1
Primary Endpoint: Safety as assessed by number of subjects with adverse events
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 17, 2025

End Date

December 31, 2031

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hangzhou Reprogenix Bioscience, Inc

Responsible Party

Sponsor

Eligibility Criteria

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

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.

Arms & Interventions

RGB-5088

Transplantation under the anterior rectus sheath

Intervention: RGB-5088

Outcomes

Primary Outcomes

Safety as assessed by number of subjects with adverse events

Time Frame: From RGB-5088 transplantation to one year later

Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events

Time Frame: From 90 days to 365 days after RGB-5088 transplantation

Secondary Outcomes

Safety as assessed by number of subjects with adverse events(From RGB-5088 transplantation to end of study (up to 5 years))
Proportion of subjects who are insulin independent(From 90 days to end of study (up to 5 years))
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events(From 90 days to end of study (up to 5 years))