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

Phase 1

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus
• Interventions: Biological: RGB-5088

• Registration Number: NCT06731218
• Lead Sponsor: Hangzhou Reprogenix Bioscience, Inc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study Start: 2024-12-11
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2027-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RGB-5088	RGB-5088	Transplantation under the anterior rectus sheath

Primary Outcome Measures

Name	Time	Method
Safety as assessed by number of subjects with adverse events	From RGB-5088 transplantation to one year later
Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events	From 90 days to 365 days after RGB-5088 transplantation

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Tianjin First Center Hospital; 🇨🇳 Tianjin, Tianjin, China