Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
Start Date
2/1/2026
Completion Date
1/1/2028
Summary
This study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of Allogeneic Hope Biosciences Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) to prevent progression of trauma-induced Acute Kidney Injury (AKI).
Detailed Description
This multicenter, prospective, randomized, double-blind, placebo-controlled pragmatic Phase 1/Phase 2a clinical study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of adiposederived allogenic MSCs to prevent progression of trauma-induced AKI. We hypothesize that infusing a total of 3 doses of MSCs over 72 hours at 24-hour intervals starting in patients with modified KDIGO Stage 2 or 3 AKI will prove to be safe and efficacious. Phase 1 of the study will include Cohort 1 (10 patients) and will confirm safety in this population with this cell formulation (cryopreserved and reanimated). Phase 2a of the study will include 60 patients (30 interventional, 30 placebo) and will look at duration of AKI at Stage 2 or higher (defined as proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment).
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Allogeneic HB-adMSCs
Normal Saline
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
University of California, San Francisco
San Francisco, California 94143
United States
University of Texas Health Science Center at Houston (UTHealth Houston)
Houston, Texas 77479
United States