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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
70
Allogeneic HB-adMSCs
Sterile Saline Solution
University of Alabama at Birmingham
Birmingham, Alabama, United States
NOT_YET_RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
NOT_YET_RECRUITINGUniversity of Texas Health Science Center at Houston (UTHealth Houston)
Houston, Texas, United States
RECRUITINGIncidence 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.
Time frame: 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
Time frame: 2 days
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.
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 1 year
Severity of complications, including incidence of sepsis, ARDS, venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF)
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Severity of each complication will be determined by complication-specific criteria, e.g. Berlin criteria (mild, moderate, severe)
Time frame: 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
Time frame: 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
Time frame: 1 year