Actively Recruiting
Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
Led by Hope Biosciences LLC · Updated on 2026-03-04
70
Participants Needed
3
Research Sites
99 weeks
Total Duration
On this page
Sponsors
H
Hope Biosciences LLC
Lead Sponsor
T
The University of Texas Health Science Center, Houston
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 75 years old
- Diagnosed with Modified KDIGO Stage 2 Acute Kidney Injury within 10 days after injury
- Admitted to Intensive Care Unit or Intermediate Medical Unit
- Received at least 3 units of blood products within 6 hours of admission for trauma, or have 15% or greater burn area, or any electrical or crush injury
- Expected to survive at least 24 hours after diagnosis of Stage 2 AKI
- Patient or legally authorized representative has signed informed consent
You will not qualify if you...
- Incarcerated individuals
- Pregnant or breastfeeding females
- Non-survivable traumatic brain injury as determined by physician
- Hemodynamically unstable requiring vasopressors for blood pressure support (systolic BP 60 mmHg) within 30 minutes before investigational product preparation
- Pre-existing chronic kidney disease or acute kidney failure
- Pre-existing chronic liver disease
- Known immunodeficiency or use of immunosuppressive medications likely causing immunosuppression
- Active cancer
- Known allergy to dimethyl sulfoxide or human serum albumin
- No intravenous access of at least 22-gauge needle available exclusively for study infusion
- Clinical condition expected to worsen with IV administration of 250 ml crystalloid
- Known Do Not Resuscitate status before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Not Yet Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
3
University of Texas Health Science Center at Houston (UTHealth Houston)
Houston, Texas, United States, 77479
Actively Recruiting
Research Team
C
Charles S Cox, Jr., MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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