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

NCT06654193 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HBAKI01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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

Keywords

acute kidney injury; stem cells; aki; hope biosciences

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Number of patients with progression of Kidney Disease Improving Global Outcomes (KDIGO) Stage 2 AKI

  1 year

• Mortality at 30, 90 days and 365 days

  1 year

• Post-injury organ dysfunction and thromboinflammation

  1 year

• Number of participants with chronic critical illness (≥14 days)

  1 year

• Severity of complications, including incidence of sepsis, ARDS, venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF)

  1 year

Other Outcomes (1)

• Number of renal injury biomarkers altered by adipose-derived MSCs

  1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Normal Saline

Treatment

EXPERIMENTAL

Allogeneic adipose-derived HB-adMSCs

Drug: Allogeneic HB-adMSCs

Interventions

Allogeneic HB-adMSCs DRUG

Allogeneic HB-adMSCs

Treatment

Normal Saline DRUG

Sterile Saline Solution

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 75 years old AND
• Diagnosed with Modified KDIGO Stage 2 AKI within the first 10 days after injury AND
• Admitted to Intensive Care Unit or Intermediate Medical Unit AND
• 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
• Expected to survive at least 24 hours after diagnosis of KDIGO Stage 2 AKI AND
• Patient or patient's Legally Authorized Representative (LAR) has voluntarily signed the informed consent.

You may not qualify if:

• Patients are ineligible if they meet ONE OR MORE of the following:
• Incarcerated individuals
• Pregnant and lactating females
• TBI deemed non-survivable by the trauma or neurosurgery attending physician
• 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
• Pre-existing chronic kidney disease or acute kidney failure.
• Pre-existing chronic liver disease.
• Known immunodeficiency or concurrent use of potentially immunosuppressive medications at doses likely to result in an immunosuppressed status.
• Active malignancy.
• Known allergy to dimethyl sulfoxide or human serum albumin.
• 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.
• Clinical condition that would be anticipated to deteriorate with IV administration of 250 ml of crystalloid.
• Known Do Not Resuscitate (DNR) prior to randomization

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• University of Alabama at Birmingham: collaborator
• Hope Biosciences LLC: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

NOT YET RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

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

Houston, Texas, 77479, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Charles S Cox, Jr., MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles S Cox, Jr., MD

CONTACT

713-500-7307; Charles.S.Cox@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This multicenter, prospective, randomized, double-blind, placebo controlled pragmatic Phase 1/Phase 2a clinical study will enroll severely injured trauma or burn patients who have developed Stage 2 AKI. Eligible patients will be randomized to receive Hope Biosciences (HB)-adMSCs or placebo administered within 24 hours of consent and in 3 doses, each 24 hours apart. 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.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 23, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (3)