Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT06731218
Recruiting Phase 1

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

NCT06731218 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou Reprogenix Bioscience, Inc
Phase
Phase 1
Started
2025-02-17
Last updated
2025-09-15

Condition(s) studied

Diabetes Mellitus, Type 1Diabetes Mellitus

Investigational drug(s) / intervention(s)

RGB-5088 →

RGB-5088: Transplantation under the anterior rectus sheath

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Tianjin First Center Hospital Tianjin Tianjin Municipality Recruiting

More Hangzhou Reprogenix Bioscience, Inc trials in China

A Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 2 Diabetes Mellitus Starting soon

Other trials for the same condition

Abnormal Glucose Tolerance in Allogeneic Hematopoietic Stem Cell Transplantation Starting soon
A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function Recruiting
New Triple Therapy in Newly Diagnosed Type 2 Diabetes Starting soon
Assessing Incretin Therapy for Cardiovascular Risk Reduction and Diabetes Remission( ITCRDR Study) Enrolling by invitation
Construction and Empirical Research of a Risk Prediction Model for Preventing Lower Extremity Arteriosclerosis Obliterans in Diabetic Patients Based on the HAPA Model Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06731218 on ClinicalTrials.gov ↗ ← All trials in China