RecruitingPhase 1NCT06731218

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


Sponsor

Hangzhou Reprogenix Bioscience, Inc

Enrollment

10 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This Phase I study is testing a new treatment called RGB-5088 in people with Type 1 diabetes to see if it is safe and whether it helps preserve or restore the body's ability to produce insulin. **You may be eligible if...** - You are 18–60 years old - You have confirmed Type 1 diabetes (including those who have had a liver or kidney transplant) - Your C-peptide level (a marker of insulin production) is very low - You have had at least one severe low blood sugar episode in the past 12 months **You may NOT be eligible if...** - You have Type 2 diabetes - You have untreated diabetic eye disease (proliferative retinopathy) - You have serious heart disease, severe gut problems, or serious mental health conditions - You have any history of cancer - You have a history of tobacco, alcohol, or drug abuse - You are pregnant, breastfeeding, or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRGB-5088

Transplantation under the anterior rectus sheath


Locations(1)

Tianjin First Center Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06731218


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