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

Chinese PLA General Hospital (301 Hospital)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Acute Kidney Injury

Mesenchymal Stem Cells

Treatments

Other: Saline

Biological: Mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT04194671

MSC-001

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
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