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

NCT ID: NCT04194671

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2022-12-31

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.

Conditions

Acute Kidney Injury; Mesenchymal Stem Cells

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mesenchymal stem cells cohort

Group Type: EXPERIMENTAL

Mesenchymal stem cells

Intervention Type: BIOLOGICAL

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

Saline cohort

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

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

Interventions

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

Intervention Type: BIOLOGICAL

Saline

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiangmei

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35190406 (View on PubMed)

Other Identifiers

MSC-001

Identifier Type: -

Identifier Source: org_study_id