Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT06654193

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury | DecenTrialz