Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
NCT ID: NCT06654193
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2026-01-31
2028-01-01
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The investigators will enroll 10 patients in Cohort 1, the Phase 1 safety substudy. All patients in Cohort 1 will receive active investigational product (IP).
The investigators will enroll 60 patients in Cohort 2, the Phase 2a substudy; 30 patients will receive active IP, and 30 will receive placebo via randomization.
The study population is trauma and burn patients admitted to participating hospitals who meet the inclusion and exclusion criteria. The study population will be reflective of the general trauma population at the participating sites.
TREATMENT
TRIPLE
Study Groups
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Placebo
Normal saline
Normal Saline
Sterile Saline Solution
Treatment
Allogeneic adipose-derived HB-adMSCs
Allogeneic HB-adMSCs
Allogeneic HB-adMSCs
Interventions
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Allogeneic HB-adMSCs
Allogeneic HB-adMSCs
Normal Saline
Sterile Saline Solution
Eligibility Criteria
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Inclusion Criteria
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
1. Incarcerated individuals
2. Pregnant and lactating females
3. TBI deemed non-survivable by the trauma or neurosurgery attending physician
4. Hemodynamically unstable and requiring vasopressors for blood pressure support (systolic blood pressure ≥90 mmHg) during the 30-minute period prior to investigational product (IP) thawing/preparation
5. Pre-existing chronic kidney disease or acute kidney failure.
6. Pre-existing chronic liver disease.
7. Known immunodeficiency or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status.
8. Active malignancy.
9. Known allergy to dimethyl sulfoxide or human serum albumin.
10. No available intravenous access (peripheral or central) of at least 22-gauge needle that can be utilized exclusively for IP during the time of planned infusion.
11. Clinical condition that would be anticipated to deteriorate with IV administration of 250 ml of crystalloid.
12. Known Do Not Resuscitate (DNR) prior to randomization
18 Years
75 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
University of California, San Francisco
OTHER
University of Alabama at Birmingham
OTHER
Hope Biosciences LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Charles S Cox, Jr., MD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
University of Texas Health Science Center at Houston (UTHealth Houston)
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Sabrina Goddard, MD
Role: primary
Joseph Cuschieri, MD
Role: primary
Charles S Cox, Jr., Dr.
Role: primary
Other Identifiers
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HBAKI01
Identifier Type: -
Identifier Source: org_study_id