Recruiting
Phase 1
Phase 2

HB-adMSCs

Sponsor:

Hope Biosciences LLC

Code:

NCT06654193

Conditions

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Allogeneic HB-adMSCs

Normal Saline

Study Details

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).

Conditions

Acute Kidney Injury

Study ID

NCT06654193

Start date

Feb 1, 2026

Status verified date

Mar, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Normal saline

experimental: Treatment

Allogeneic adipose-derived HB-adMSCs

Interventions

Allogeneic HB-adMSCs

Allogeneic HB-adMSCs

Normal Saline

Sterile Saline Solution

Primary outcome measure

  • Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs) [ Time Frame: 1 year ]
  • Duration of Acute Kidney Injury (AKI) at Stage 2 [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Health Science Center at Houston (UTHealth Houston)

Recruiting

Houston, Texas, United States, 77479

Contacts

Principal Investigator:

Charles S Cox, Jr., Dr.

More Information

Sponsor

Hope Biosciences LLC

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • acute kidney injury
  • stem cells
  • aki
  • hope biosciences

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hope Biosciences LLC on 2026-03-04.