NCT06654193 Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury
| NCT ID | NCT06654193 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hope Biosciences LLC |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2026-02-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Charles S Cox, Jr., MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06654193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06654193 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06654193 currently recruiting?
Yes, NCT06654193 is actively recruiting participants. Contact the research team at Charles.S.Cox@uth.tmc.edu for enrollment information.
Where is the NCT06654193 trial being conducted?
This trial is being conducted at Birmingham, United States, San Francisco, United States, Houston, United States.
Who is sponsoring the NCT06654193 clinical trial?
NCT06654193 is sponsored by Hope Biosciences LLC. The principal investigator is Charles S Cox, Jr., MD at The University of Texas Health Science Center, Houston. The trial plans to enroll 70 participants.
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