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

NCT06731218 · Hangzhou Reprogenix Bioscience, Inc
In plain English

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Official title
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
About this study
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 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.
Study design
Enrollment target: 10 participants
Allocation: na
Masking: none
Age groups: adult
Timeline
Starts: 2025-02-17
Estimated completion: 2031-12-31
Last updated: 2025-09-15
Interventions
Biological: RGB-5088
Primary outcomes
  • 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)
Sponsor
Hangzhou Reprogenix Bioscience, Inc · industry
Contacts & investigators
ContactLinlin Jiang · contact · Linlin.jiang@reprogenix.com · +86+571-88601920
All locations (1)
Tianjin First Center HospitalRecruiting
Tianjin, Tianjin Municipality, China
Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus · TrialPath