Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury (AKI)

Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Normal Saline; Drug: Allogeneic HB-adMSCs

Detailed Description

This multicenter, prospective, randomized, double-blind, placebo-controlled pragmatic Phase 1/Phase 2a clinical study aims to investigate, through the collection of valid scientific evidence necessary to determine safety and effectiveness, the potential use of adiposederived allogenic MSCs to prevent progression of trauma-induced AKI. We hypothesize that infusing a total of 3 doses of MSCs over 72 hours at 24-hour intervals starting in patients with modified KDIGO Stage 2 or 3 AKI will prove to be safe and efficacious.

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).

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Charles S Cox, Jr., MD; Phone Number: 713-500-7307; Email: Charles.S.Cox@uth.tmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Not yet recruiting
      • University of Alabama at Birmingham
      • Contact: Sabrina Goddard, MD
      • Principal Investigator: Sabrina Goddard, MD
      • Sub-Investigator: John B Holcomb, MD
  • California
    • San Francisco, California, United States, 94143
      • Not yet recruiting
      • University of California, San Francisco
      • Sub-Investigator: Lucy Kornblith, MD
      • Contact: Joseph Cuschieri, MD
      • Principal Investigator: Joseph Cuschieri, MD
      • Principal Investigator: Shibani Pati, MD, PhD
      • Sub-Investigator: Kathleen Liu, MD, PhD
  • Texas
    • Houston, Texas, United States, 77479
      • Recruiting
      • University of Texas Health Science Center at Houston (UTHealth Houston)
      • Sub-Investigator: Claudia Pedroza, PhD
      • Contact: Charles S Cox, Jr., Dr.; Phone Number: 713-500-7307; Email: Charles.S.Cox@uth.tmc.edu
      • Principal Investigator: Charles S Cox, Jr., Dr.
      • Sub-Investigator: Erin E Fox, PhD
      • Sub-Investigator: John Harvin, MD, MS
      • Sub-Investigator: Laura Moore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Normal saline	Drug: Normal Saline; Sterile Saline Solution
Experimental: Treatment; Allogeneic adipose-derived HB-adMSCs	Drug: Allogeneic HB-adMSCs; Allogeneic HB-adMSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)	Incidence of treatment-related adverse events (TEAEs) will be monitored to assess the safety of the infusion product on the patients in Phase 1 of the trial.	1 year
Duration of Acute Kidney Injury (AKI) at Stage 2	Proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with progression of Kidney Disease Improving Global Outcomes (KDIGO) Stage 2 AKI	The progression from Stage 2 to Stage 3 AKI often constitutes the initiation of renal replacement therapy (RRT), tripling of creatinine levels or creatinine > 4 mg/dL with an increase of 0.5 mg/dL, with an associated marked increase in morbidity, mortality, and cost.	1 year
Mortality at 30, 90 days and 365 days	Whether the patient remains alive or not at 1 month, 3 months, and 1 year	1 year
Severity of complications, including incidence of sepsis, ARDS, venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF)	Severity of each complication will be determined by complication-specific criteria, e.g. Berlin criteria (mild, moderate, severe)	1 year
Number of patients with Recurrent AKI during the same hospitalization	Defined as the amount of patients who have several episodes of AKI in the same hospitalization	1 year
Post-injury organ dysfunction and thromboinflammation	Includes incidence of sepsis, acute respiratory distress syndrome (ARDS), venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF)	1 year
Number of participants with chronic critical illness (≥14 days)	Determined by prolonged intensive care unit (ICU) admission (≥14 days) with evidence of ongoing organ dysfunction	1 year
Hospital-, ICU- and ventilator-free days	Defined as the number of days a patient was not in the hospital or on the ventilator or in the ICU at 30 days or hospital discharge/death	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of renal injury biomarkers altered by adipose-derived MSCs	8 plasma samples from enrolled patients at timepoints from the time of enrollment will be collected. The investigators hypothesize that MSC treatment would result in attenuation of dysregulated inflammation and endothelial injury will be reduced.	1 year

Collaborators and Investigators

• Sponsor: Hope Biosciences LLC
• Collaborators: The University of Texas Health Science Center, Houston; University of Alabama at Birmingham; University of California, San Francisco
• Investigators: Principal Investigator: Charles S Cox, Jr., MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: acute kidney injury; stem cells; aki; hope biosciences
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: HBAKI01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No