RecruitingPhase 1NCT07275788

A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)

An Exploratory Study of REGEND003 Kidney Progenitor Cells on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)


Sponsor

Regend Therapeutics

Enrollment

15 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

REGEND003, which consists of human kidney progenitor cells, demonstrates promising potential in repairing kidney injury. The purpose of this study is to assess the saftey and tolerability of REGEND003 on patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease. It is an exploratory study with multi-centered, randomized, controlled, single-blinded, dose-escalated designs.


Eligibility

Min Age: 30 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing REGEND003, an experimental treatment, in people who have both Type 2 diabetes and chronic kidney disease (CKD). Researchers want to see if it can slow kidney damage in these patients. **You may be eligible if...** - You are 30–75 years old - You have had Type 2 diabetes for at least 1 year - You have been diagnosed with chronic kidney disease - You are willing to follow all study procedures **You may NOT be eligible if...** - You are pregnant, nursing, or planning a pregnancy within a year - You have active HIV, syphilis, hepatitis B (active, not carrier), or hepatitis C (active) - You have a current or recent cancer (within 2 years) - You have Type 1 diabetes - You are on dialysis - You have had severe low blood sugar episodes recently - You cannot tolerate a kidney biopsy or injection procedure - You have a history of kidney transplant or inherited kidney disease - You have a recent severe illness, psychiatric history, or epilepsy 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

BIOLOGICALREGEND003

REGEND003

OTHERPlacebo

Placebo


Locations(1)

Shanghai Tongji Hospital

Shanghai, China

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NCT07275788