Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn
Hope Biosciences LLC
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).
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…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Between 18 and 75 years old AND 2. Diagnosed with Modified KDIGO Stage 2 AKI within the first 10 days after injury AND 3. Admitted to Intensive Care Unit or Intermediate Medical Unit AND 4. Received at least 3 units of any blood product within 6 hours of admission for trauma OR 15% or greater burn area OR any electrical burn OR any crush injury AND 5. Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI AND 6. Patient or patient's Legally Authorized Representative (LAR) has voluntarily signed the informed consent. Exclusion Criteria: Patients are…
Interventions
- DrugAllogeneic HB-adMSCs
Allogeneic HB-adMSCs
- DrugNormal Saline
Sterile Saline Solution
Locations (3)
- University of Alabama at BirminghamBirmingham, Alabama
- University of California, San FranciscoSan Francisco, California
- University of Texas Health Science Center at Houston (UTHealth Houston)Houston, Texas