Back to resultsClinical Trial of Mesenchymal Stem Cells in the Treatment of Severe Acute Kidney Injury
Primary Purpose
Acute Kidney Injury, Mesenchymal Stem Cells
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mesenchymal stem cells
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury
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
Sites / Locations
- Chinese PLA General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mesenchymal stem cells cohort
Saline cohort
Arm Description
Outcomes
Primary Outcome Measures
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
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
Overall survival within 28 days after receiving MSC/ placebo treatment
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Overall survival within 3 months after receiving MSC/ placebo treatment
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment
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.
Complete renal recovery within 3 months after receiving MSC/ placebo treatment
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
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.
ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment
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.
Adverse events within 3 months after receiving MSC/ placebo treatment
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.
Full Information
NCT ID
NCT04194671
First Posted
December 9, 2019
Last Updated
October 19, 2021
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04194671
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2021 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Mesenchymal Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal stem cells cohort
Arm Type
Experimental
Arm Title
Saline cohort
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
In placebo control group, patients receive standard treatment and saline is administered via intravenous infusion on day 0 and day 7
Primary Outcome Measure Information:
Title
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
Description
Compare the creatinine concentration between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Time Frame
within 28 days after receiving MSC/ placebo treatment
Secondary Outcome Measure Information:
Title
Overall survival within 28 days after receiving MSC/ placebo treatment
Description
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Time Frame
28 days
Title
Overall survival within 3 months after receiving MSC/ placebo treatment
Description
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
Time Frame
3 months
Title
Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment
Description
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.
Time Frame
3 months
Title
Complete renal recovery within 3 months after receiving MSC/ placebo treatment
Description
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.
Time Frame
3 months
Title
Partial renal recovery within 3 months after receiving MSC/ placebo treatment
Description
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.
Time Frame
3 months
Title
ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment
Description
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.
Time Frame
3 months
Title
Adverse events within 3 months after receiving MSC/ placebo treatment
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Data will be available beginning immediately following publication and ending 36 months following article publication.
Citations:
PubMed Identifier
35190406
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.
Results Reference
derived
Learn more about this trial
Clinical Trial of Mesenchymal Stem Cells in the Treatment of Severe Acute Kidney Injury
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