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

NCT07275788 | Recruiting Phase 1

• 1 other identifier: REGEND003-CKD-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)

Keywords

Type 2 Diabetes Mellitus; Chronic Kidney Disease; Cell Therapy; Kidney Progenitor Cells

Outcome Measures

Primary Outcomes (1)

• Adverse Event (AE) associated with the Cell Therapy

  The incidence and severity of adverse events will be evaluated.

  Within 24 weeks post-treatment

Secondary Outcomes (11)

• Complications associated with Intrarenal Injection

  Within 24 weeks post-treatment

• Change from Baseline in Concentration of C-Reactive Protein

  Within 24 weeks post-treatment

• Change from Baseline in Glomerular Filtration Rate (GFR)

  Within 24 weeks post-treatment

• Change from Baseline in Concentration of Serum Creatinine

  Within 24 weeks post-treatment

• Change from Baseline in 24-Hour Urinary Protein Excretion

  Within 24 weeks post-treatment

Study Arms (2)

REGEND003

EXPERIMENTAL

REGEND003 for dosage escalation

Biological: REGEND003

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

REGEND003 BIOLOGICAL

REGEND003

REGEND003

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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;

Sponsors & Collaborators

• Regend Therapeutics: lead
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator

Study Sites (1)

Shanghai Tongji Hospital

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Prof. Yu

CONTACT

086-021-66111062; yuchen@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 10, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)