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)
Facility
City
Region
Status
Tianjin First Center Hospital
Tianjin
Tianjin Municipality
Recruiting
More Hangzhou Reprogenix Bioscience, Inc trials in China
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.
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