Mesenchymal Stem Cells for Chronic Kidney Diseases

NCT07240987 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: KY20242307
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the effect of intravenous injection of umbilical cord tissue derived mesenchymal stem cells (UMSCs) on the improvement of renal function in patients with chronic kidney disease (CKD) at stage 3 or 4, with the change of estimated glomerular filtration rate (eGFR) as the primary endpoint, and other changes in renal function laboratory indicators, changes in other organ system function laboratory indicators, and adverse reaction events as secondary endpoints. This trial aims to further evaluate the efficacy and safety of UMCSs in CKD patients, and provide new insights into expanding the clinical treatment strategies, delaying the progression and improving the prognosis of CKD patients.

Conditions

Kidney Disease, Chronic; Diabetic Kidney Disease (DKD); Hypertensive Nephropathy

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Efficacy Endpoints: Changes in eGFR, 24-hour urine protein, and UACR at 1, 3, 6, and 12 months will serve as primary endpoints to assess renal function improvement. Changes in other renal function parameters (e.g., quantitative urine protein, urine red blood cells, serum creatinine, cystatin C),and changes in other organ system function parameters (e.g., ECG/echocardiography, complete blood count, liver function, NT-proBNP, parathyroid hormone, 25-dihydroxyvitamin D, lymphocyte subsets) at 1, 3, 6, and 12 months will serve as secondary endpoints.

  From enrollment to the end of treatment at 12 months

Study Arms (4)

DKD

EXPERIMENTAL

Drug: MSCs

HN

EXPERIMENTAL

Drug: MSCs

non-DKD

PLACEBO COMPARATOR

Drug: 0.9% sodium chloride

non-HN

PLACEBO COMPARATOR

Drug: 0.9% sodium chloride

Interventions

0.9% sodium chloride DRUG

The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.

non-DKD; non-HN

MSCs DRUG

The experimental group will receive an intravenous injection of allogeneic MSCs at a dose of 1.0×10⁶ cells per kilogram, reconstituted with 250 mL of sodium chloride injection.

DKD; HN

Eligibility Criteria

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

You may qualify if:

• Agreement to participate in the trial and provision of signed written informed consent
• Pathological diagnosis of diabetic nephropathy or hypertensive renal damage
• ≤ eGFR \< 60 mL/min/1.73m², UACR \> 300 mg/g
• Age ≥ 18 years

You may not qualify if:

• Extremely severe anemia (hemoglobin \< 30 g/L)
• Received blood product transfusion therapy within 1 month
• Autosomal dominant or recessive polycystic kidney disease (ADPKD)
• History of kidney transplant or other solid organ transplant
• Active systemic or localized infection (e.g., pneumonia, osteomyelitis)
• Allergy to stem cells themselves or stem cell-related culture medium
• History of allergic reaction to cell products (e.g., blood transfusion, platelets)
• History of coagulation disorders (thromboembolism, pulmonary embolism, deep vein thrombosis)
• History of malignancy or current malignant disease
• Elevated tumor markers (AFP, CEA, CA199, CA125, etc.)
• Pregnant women or women with plans for pregnancy within 3 months after MSC therapy
• Participation in drug-related clinical trials within the past 2 months
• Any form of drug abuse, mental illness, or other conditions considered by the investigator as potentially affecting the trial's validity or the subject's health

Sponsors & Collaborators

• The First Affiliated Hospital of Air Force Medicial University: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetic Nephropathies; Hypertensive Nephropathy

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12