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

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ClinicalTrials.gov Identifier: NCT04194671
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Mesenchymal Stem Cells Biological: Mesenchymal stem cells Other: Saline Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 31, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal stem cells cohort Biological: Mesenchymal stem cells
In experimental group, patients receive standard treatment and allogeneic human umbilical cord derived-mesenchymal stem cells (MSCs) is administered via intravenous infusion on day 0 and day 7
Placebo Comparator: Saline cohort Other: Saline
In placebo control group, patients receive standard treatment and saline is administered via intravenous infusion on day 0 and day 7


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: 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 :
  1. Overall survival within 28 days after receiving MSC/ placebo treatment [ Time Frame: 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.

  2. Overall survival within 3 months after receiving MSC/ placebo treatment [ Time Frame: 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.

  3. Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment [ Time Frame: 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.

  4. Complete renal recovery within 3 months after receiving MSC/ placebo treatment [ Time Frame: 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.

  5. Partial renal recovery within 3 months after receiving MSC/ placebo treatment [ Time Frame: 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.

  6. ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment [ Time Frame: 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.

  7. Adverse events within 3 months after receiving MSC/ placebo treatment [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194671


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chen Xiangmei, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT04194671    
Other Study ID Numbers: MSC-001
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: Data will be available beginning immediately following publication and ending 36 months following article publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases