NCT07275788
Recruiting
Phase 1
An Exploratory Study of REGEND003 Kidney Progenitor Cells on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)
Regend Therapeutics1 site in 1 country15 target enrollmentStarted: January 8, 2026Last updated:
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Regend Therapeutics
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Adverse Event (AE) associated with the Cell Therapy
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
REGEND003
Experimental
REGEND003 for dosage escalation
Intervention: REGEND003 (Biological)
Placebo
Placebo Comparator
Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Adverse Event (AE) associated with the Cell Therapy
Time Frame: Within 24 weeks post-treatment
The incidence and severity of adverse events will be evaluated.
Secondary Outcomes
- 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)
- Change from Baseline in Urine Albumin-Creatinine Ratio (uACR)(Within 24 weeks post-treatment)
- Change from Baseline in Kidney Volume(Winthin 24 weeks post-treatment)
- Change from Baseline in Renal Cortical Thickness (RCT)(Within 24 weeks post-treatment)
- Changes from Baseline in the Outcomes from Kidney Disease Quality of Life (KDQOL) Survey(Within 24 weeks post-treatment)
- Change from Baseline in Blood Pressure(Within 24 weeks post-treatment)
- Time from Injection to First Kidney Disease Progression (KDP)(Within 24 weekd post-treatment)
Investigators
Study Sites (1)
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