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)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
• Intervention / Treatment: Other: Placebo; Biological: REGEND003

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Prof. Yu; Phone Number: 086-021-66111062; Email: yuchen@tongji.edu.cn

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Shanghai Tongji Hospital
    • Contact: Prof. Yu; Phone Number: 086-021-66111062; Email: yuchen@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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);
• At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test.

Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well.

• Presence of a current or prior history of malignant tumor at screening (with the exception of those with disease-free survival for more than 2 years, or malignancies deemed to be of low aggressiveness as assessed by the investigator).
• Patients with Type 1 Diabetes Mellitus;
• Patients undergoing regular hemodialysis or peritoneal dialysis;
• Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening;
• Presence of more than one episode of hypoglycemic coma (blood glucose ≤3.9 mmol/L) within 1 month prior to screening;
• Patients intolerant to renal puncture/intrarenal injection procedures;
• Patients with diagnosis of acute kidney injury, congenital or hereditary kidney diseases, renal atrophy, or other renal conditions deemed ineligible by the investigator, as well as patients with a history of kidney transplantation at screening;
• Presence of severe systemic diseases within 6 months prior to screening and judged by the investigator as unsuitable for the study;
• Patients requiring long-term anticoagulant or antiplatelet therapy who, in the investigator's judgment, cannot discontinue medication 1 week prior to renal puncture/intrarenal injection procedures;
• Patients with suicidal risk, history of psychiatric disorders, or history of epilepsy at screening;
• Patients with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening;
• Patients participated in other clinical trials with interventions within 1 month prior to screening;
• Subject with assessed survival time of less than 1 year by investigators at screening;
• Investigators, co-investigators, study coordinators, employees of participating investigators or research centers, or family members of the above individuals;
• Any condition that, in the investigator's judgment, may increase subject risk or interfere with the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo
Experimental: REGEND003; REGEND003 for dosage escalation	Biological: REGEND003; REGEND003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event (AE) associated with the Cell Therapy	The incidence and severity of adverse events will be evaluated.	Within 24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications associated with Intrarenal Injection	The incidence will be evaluated.	Within 24 weeks post-treatment
Change from Baseline in Concentration of C-Reactive Protein	C-Reactive Protein is a marker of inflammation in the body.	Within 24 weeks post-treatment
Change from Baseline in Glomerular Filtration Rate (GFR)	GFR is a critical measurement of kidney function, reflecting how efficiently the kidneys filter blood	Within 24 weeks post-treatment
Change from Baseline in Concentration of Serum Creatinine	A creatinine test is a measure of how well the kidneys are doing their job of filtering waste from the blood.	Within 24 weeks post-treatment
Change from Baseline in 24-Hour Urinary Protein Excretion	A 24-hour urine protein test measures the amount of albumin (the most common protein filtered in the kidney) in the urine over 24 hours.	Within 24 weeks post-treatment
Change from Baseline in Urine Albumin-Creatinine Ratio (uACR)	A urine albumin-creatinine ratio (uACR) is a urine (pee) test that help to understand the overall kidney health. A high uACR may be a sign of kidney disease.	Within 24 weeks post-treatment
Change from Baseline in Kidney Volume	Kidney volume provides key insights in many clinical situations. Abnormal kidney volumes often signal problems.	Winthin 24 weeks post-treatment
Change from Baseline in Renal Cortical Thickness (RCT)	RCT has also been used in the diagnosis of chronic kidney disease. With the progression of the disease, RCT decreases.	Within 24 weeks post-treatment
Changes from Baseline in the Outcomes from Kidney Disease Quality of Life (KDQOL) Survey	The Kidney Disease Quality of Life (KDQOL) survey has long been used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life. The minimal value is 0 and the maximal value is 100. A higher score means a better outcome.	Within 24 weeks post-treatment
Change from Baseline in Blood Pressure	Both systolic and diastolic blood pressures are assessed.	Within 24 weeks post-treatment
Time from Injection to First Kidney Disease Progression (KDP)	KDP is assessed by stage of disease, mortality and continous decreasing of GFR.	Within 24 weekd post-treatment

Collaborators and Investigators

• Sponsor: Regend Therapeutics
• Collaborators: Shanghai Tongji Hospital, Tongji University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cell Therapy; Chronic Kidney Disease; Type 2 Diabetes Mellitus; Kidney Progenitor Cells
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic
• Other Study ID Numbers: REGEND003-CKD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No