NCT06731218RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 17 Feb 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Hangzhou Reprogenix Bioscience, Inc
- Diseases
- Type 1 diabetes
- NCT number
- NCT06731218
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 17 Feb 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 2 diabetes patients;
- Untreated proliferative diabetes retinopathy;
- Serious heart disease;
- Serious psychological diseases；
- Any history of malignancy;
- Have a history of tobacco, alcohol and drug abuse;
Other
- Serious gastrointestinal dysfunction ；
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin First Center Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.