Actively Recruiting
A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
Led by Regend Therapeutics · Updated on 2026-03-17
15
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
R
Regend Therapeutics
Lead Sponsor
S
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 30 to 75 years at the time of signing the informed consent form
- Diagnosed with Type 2 Diabetes Mellitus for at least 1 year
- Diagnosed with Chronic Kidney Disease (CKD)
- Voluntarily sign the informed consent form, be able to cooperate in completing study-related procedures and examinations, capable of adequately recording or describing changes in their condition, and demonstrate strong compliance.
You will not qualify if you...
- Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant)
- Positive for treponema pallidum antibody (TP-Ab), HIV antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening
- Presence of current or prior malignant tumor at screening, except disease-free for more than 2 years or low aggressiveness malignancies
- Patients with Type 1 Diabetes Mellitus
- Patients undergoing regular hemodialysis or peritoneal dialysis
- Severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening
- More than one episode of hypoglycemic coma within 1 month prior to screening
- Intolerant to renal puncture/intrarenal injection procedures
- Diagnosis of acute kidney injury, congenital or hereditary kidney diseases, renal atrophy, or other ineligible renal conditions, or history of kidney transplantation
- Severe systemic diseases within 6 months prior to screening judged unsuitable for the study
- Requires long-term anticoagulant or antiplatelet therapy unable to discontinue 1 week prior to renal puncture/intrarenal injection
- Suicidal risk, history of psychiatric disorders, or epilepsy at screening
- Severe arrhythmias or heart conduction disorders (degree II or above) on 12-lead ECG at screening
- Participation in other clinical trials with interventions within 1 month prior to screening
- Assessed survival time less than 1 year at screening
- Investigators, study staff, or family members of these individuals
- Any condition that may increase risk or interfere with the trial as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Tongji Hospital
Shanghai, China, 200000
Actively Recruiting
Research Team
P
Prof. Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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