Mesenchymal Stem Cells for Chronic Kidney Diseases

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

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorThe First Affiliated Hospital of Air Force Medicial University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Agreement to participate in the trial and provision of signed written informed consent

Pathological diagnosis of diabetic nephropathy or hypertensive renal damage

15 ≤ eGFR < 60 mL/min/1.73m², UACR > 300 mg/g

Age ≥ 18 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

32 Participants

are divided into 4 treatment groups

Group A: DKDExperimental treatment 1 intervention

Group B: HNExperimental treatment 1 intervention

Group C: non-DKDPlacebo comparator 1 intervention

Group D: non-HNPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment to the end of treatment at 12 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Air Force Medicial University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: