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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04194671
• Other study ID #: MSC-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 31, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Mesenchymal Stem Cells
• Wounds and Injuries

Intervention

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

Other:
• Saline
In placebo control group, patients receive standard treatment and saline is administered via intravenous infusion on day 0 and day 7

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 28 days after receiving MSC/ placebo treatment
Secondary	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.	28 days
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months