NCT04194671

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

A Single-center, Randomized, Placebo-controlled, Patient-blinded Study of Mesenchymal Stem Cells Therapy in Subjects With Severe Acute Kidney Injury Receiving Routine Therapy

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-12-31
• Primary completion: 2022-10-31
• Completion: 2022-12-31
• First posted: 2019-12-11
• Last updated: 2021-10-25

Locations

1 site across 1 country: China