Phase I Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 1 Diabetes Mellitus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RGB-5088.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1, Diabetes Mellitus. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological RGB-5088
Transplantation under the anterior rectus sheath
Primary outcome measures
- Safety as assessed by number of subjects with adverse events [Time frame: From RGB-5088 transplantation to one year later]
- Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events [Time frame: From 90 days to 365 days after RGB-5088 transplantation]
Secondary outcome measures (3)
- Safety as assessed by number of subjects with adverse events [Time frame: From RGB-5088 transplantation to end of study (up to 5 years)]
- Proportion of subjects who are insulin independent [Time frame: From 90 days to end of study (up to 5 years)]
- Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events [Time frame: From 90 days to end of study (up to 5 years)]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin First Center Hospital — Tianjin
Identifiers
NCT: NCT06731218 · RGB-5088-01