Could stem cells shield kidneys after severe injury?
NCT ID NCT06654193
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether stem cells from donated fat tissue can prevent kidney injury from getting worse in people who have been severely hurt in accidents or burns. About 70 ICU patients will receive either stem cells or a placebo. The goal is to see if the treatment is safe and helps kidneys recover faster, reducing the need for dialysis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs)
- What this could lead to
- If it works, this could point toward a treatment that prevents acute kidney injury from getting worse after severe trauma or burn, reducing the need for dialysis.
- What could go wrong
- This is an early Phase 1/2 trial with only 70 participants, so results are preliminary. Stem cell infusions carry risks like allergic reactions or infection, and the treatment may not improve kidney function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ineligible if they meet ONE OR MORE of the following: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Alabama at Birmingham
NOT_YET_RECRUITINGBirmingham, Alabama, 35294, United States
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University of California, San Francisco
NOT_YET_RECRUITINGSan Francisco, California, 94143, United States
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University of Texas Health Science Center at Houston (UTHealth Houston)
RECRUITINGHouston, Texas, 77479, United States
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Other studies related to the condition(s) this trial covers.
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- ICU kidney injury: does the pattern predict lasting damage?
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?
- Two blood tests may separate real kidney harm from a false alarm
- Can watching kidney oxygen during liver surgery keep kidneys safe?