RGB-5088 islet cell transplantation for Type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I, single-center, single-arm, open-label trial of RGB-5088 islet cell transplantation in adults with Type 1 diabetes. The study enrolls patients aged 18–60 with stimulated C-peptide < 0.3 ng/mL who have had at least one severe hypoglycemic episode in the prior 12 months. Participants will receive RGB-5088 transplantation and undergo close monitoring for safety, changes in C-peptide, insulin requirements, and episodes of hypoglycemia. The main goal is to characterize safety and early signals of therapeutic effect to guide further development.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin First Center Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Linlin Jiang
• Email: Linlin.jiang@reprogenix.com
• Phone: +86+571-88601920

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.