Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2026-01-01
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DKD
MSCs
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.
HN
MSCs
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.
non-DKD
0.9% sodium chloride
The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.
non-HN
0.9% sodium chloride
The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.
Interventions
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0.9% sodium chloride
The control group will receive a placebo, which is an intravenous infusion of 250 mL of 0.9% sodium chloride injection.
MSCs
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.
Eligibility Criteria
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Inclusion Criteria
* Pathological diagnosis of diabetic nephropathy or hypertensive renal damage
* 15 ≤ eGFR \< 60 mL/min/1.73m², UACR \> 300 mg/g
* Age ≥ 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Air Force Medicial University
OTHER
Responsible Party
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Li Jipeng
Principal Investigator
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Study Protocol: English Translation Version2
Other Identifiers
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KY20242307
Identifier Type: -
Identifier Source: org_study_id