Clinical trial NCT04194671: Clinical Trial of Mesenchymal Stem Cells in the Treatment of Severe Acute Kidney Injury
Official title: A Single-center, Randomized, Placebo-controlled, Patient-blinded Study of Mesenchymal Stem Cells Therapy in Subjects With Severe Acute Kidney Injury Receiving Routine Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Kidney Injury
Mesenchymal Stem Cells
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: within 28 days after receiving MSC/ placebo treatment
Secondary outcomes:
measure: Overall survival within 28 days after receiving MSC/ placebo treatment
timeFrame: 28 days
measure: Overall survival within 3 months after receiving MSC/ placebo treatment
timeFrame: 3 months
measure: Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment
timeFrame: 3 months
measure: Complete renal recovery within 3 months after receiving MSC/ placebo treatment
timeFrame: 3 months
measure: Partial renal recovery within 3 months after receiving MSC/ placebo treatment
timeFrame: 3 months
measure: ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment
timeFrame: 3 months
measure: Adverse events within 3 months after receiving MSC/ placebo treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
citation: Yang Y, Gao J, Wang S, Wang W, Zhu FL, Wang X, Liang S, Feng Z, Lin S, Zhang L, Chen X, Cai G. Efficacy of umbilical cord mesenchymal stem cell transfusion for the treatment of severe AKI: a protocol for a randomised controlled trial. BMJ Open. 2022 Feb 21;12(2):e047622. doi: 10.1136/bmjopen-2020-047622.