Clinical Trial of Mesenchymal Stem Cells in the Treatment of Severe Acute Kidney Injury

Phase 1

• Conditions: Acute Kidney Injury; Mesenchymal Stem Cells
• Interventions: Other: Saline; Biological: Mesenchymal stem cells

• Registration Number: NCT04194671
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Acute kidney injury(AKI) is a common, severe emergency case in clinics,especially severe AKI ,which is associated with higher morbidity and mortality. Effect of routine therapy is limited and mesenchymal stem cells (MSC)are considered a new therapy for treating severe acute kidney injury. Patients will be randomized to receive intravenous infusion of MSC, or placebo control. This trial is to investigate whether MSC can improve renal recovery and mortality of patients with AKI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-25
• Study Start: 2021-12-31
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Have severe AKI defined as more than two-fold increase serum creatinine level compared with baseline within 48 hours and/or urinary output consistently<0.5 ml/kg/h over 12 hours
• Age between 18 and 65 years
• Willing or having a legally acceptable representative to give a written informed consent
• Able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up

Exclusion Criteria

• AKI due to post-renal outflow obstruction,glomerulonephritis,lupus nephritis, antineutrophil cytoplasmic antibody (ANCA) related nephritis, antiglomerular basement membrane disease, cryoglobulinemia, thrombotic microangiopathy, and AKI caused by purpura nephritis
• Pregnant or lactating woman
• Allergic person
• Organ transplant or hematopoietic stem cell transplant
• Patients with malignant tumors or those with a history of cancer
• Life expectancy is less than 3 months
• Known end-stage liver disease
• Uncontrollable infection
• Patients younger than 65 years old ,whose estimated glomerular filtration rate (eGFR) were less than 60
• Severe pulmonary dysfunction
• Severe cardiac dysfunction,left ventricular ejection fraction is less than 40%, or severe arrhythmia patients
• Hemodynamically unstable patients
• Organ failure affecting more than 2 non-renal organs
• Acute or chronic vasculitis of any cause
• History of chronic systemic infection of any cause
• The investigators believe that subjects may need to gradually increase the dose of vasopressor to achieve and / or maintain hemodynamic stability
• Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of >15 mg/day of prednisone or the equivalent within the past 30 days
• Platelet count <25,000/uL or other severe hematologic abnormalities, causing the subject to be at risk of death
• Patients need mechanical ventilation
• Participate in other clinical trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline cohort	Saline	-
Mesenchymal stem cells cohort	Mesenchymal stem cells	-

Primary Outcome Measures

Name	Time	Method
The difference in the renal function between the two groups (MSC treatment group vs placebo control group) within 28 days after receiving MSC/ placebo treatment	within 28 days after receiving MSC/ placebo treatment	Compare the creatinine concentration between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.

Secondary Outcome Measures

Name	Time	Method
Overall survival within 28 days after receiving MSC/ placebo treatment	28 days	Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment	3 months	Compare the rate of renal replacement therapy (RRT) dependence between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
Adverse events within 3 months after receiving MSC/ placebo treatment	3 months	Compare the rate of adverse events between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment.
Complete renal recovery within 3 months after receiving MSC/ placebo treatment	3 months	Compare the rate of complete renal recovery between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment. We considered complete recovery as alive, free of RRT, and the SCR decreased to no more than 1.5 times of the baseline level.
Partial renal recovery within 3 months after receiving MSC/ placebo treatment	3 months	Compare the rate of partial renal recovery between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment. Partial recovery refers to survival, free of RRT, and the SCR 1.5 times higher than the baseline level of creatinine.
Overall survival within 3 months after receiving MSC/ placebo treatment	3 months	Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment	3 months	Compare the days in ICU and hospital between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China