Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2025
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2024
CompletedFirst Posted
Study publicly available on registry
December 12, 2024
CompletedStudy Start
First participant enrolled
February 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
September 15, 2025
September 1, 2025
2.9 years
December 9, 2024
September 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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)
Study Arms (1)
RGB-5088
EXPERIMENTALTransplantation under the anterior rectus sheath
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin First Center Hospital
Tianjin, Tianjin Municipality, 300000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2024
First Posted
December 12, 2024
Study Start
February 17, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2031
Last Updated
September 15, 2025
Record last verified: 2025-09