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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04194671
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Chen Xiangmei, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Placebo-controlled, Single -Blind Study of Mesenchymal Stem Cells Therapy in Subjects With Severe Acute Kidney Injury Receiving Routine Therapy
Estimated Study Start Date : January 31, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022

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




Primary Outcome Measures :
  1. Progession of renal function in patients within 28 days after receiving MSC treatment [ Time Frame: within 28 days after receiving MSC treatment ]

Secondary Outcome Measures :
  1. Overall survival within 28 days after receiving MSC treatment [ Time Frame: 28 days ]
  2. Overall survival within 3 months after receiving MSC treatment [ Time Frame: 3 months ]
  3. RRT dependent within 3 months after receiving MSC treatment [ Time Frame: 3 months ]
  4. Complete renal recovery within 3 months after receiving MSC treatment [ Time Frame: 3 months ]
  5. Partial renal recovery within 3 months after receiving MSC treatment [ Time Frame: 3 months ]
  6. Duration of ICU among survivors within 3 months [ Time Frame: 3 months ]
  7. Duration of hospitalization among survivors within 3 months [ Time Frame: 3 months ]
  8. Adverse events within 3 months [ Time Frame: 3 months ]


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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 65years
  • 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, 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 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
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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: December 16, 2019
Last Verified: December 2019

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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