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

NCT04194671 | Unknown Phase 1

• 1 other identifier: MSC-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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

  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 Outcomes (7)

• Overall survival within 28 days after receiving MSC/ placebo treatment

  28 days

• Overall survival within 3 months after receiving MSC/ placebo treatment

  3 months

• Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment

  3 months

• Complete renal recovery within 3 months after receiving MSC/ placebo treatment

  3 months

• Partial renal recovery within 3 months after receiving MSC/ placebo treatment

  3 months

Study Arms (2)

Mesenchymal stem cells cohort

EXPERIMENTAL

Biological: Mesenchymal stem cells

Saline cohort

PLACEBO COMPARATOR

Other: Saline

Interventions

Mesenchymal stem cells 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

Mesenchymal stem cells cohort

Saline OTHER

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

Saline cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• 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.

  PMID: 35190406 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: December 31, 2021
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning immediately following publication and ending 36 months following article publication.

Locations

CN (1)