Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn
Overview
- Phase
- Phase 1
- Intervention
- Normal Saline
- Conditions
- Not specified
- Sponsor
- Hope Biosciences LLC
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)
- Status
- Recruiting
- Last Updated
- last month
Overview
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).
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Placebo
Normal saline
Intervention: Normal Saline
Treatment
Allogeneic adipose-derived HB-adMSCs
Intervention: Allogeneic HB-adMSCs
Outcomes
Primary Outcomes
Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)
Time Frame: 1 year
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.
Duration of Acute Kidney Injury (AKI) at Stage 2
Time Frame: 2 days
Proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment
Secondary Outcomes
- 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)
- Hospital-, ICU- and ventilator-free days(1 year)
- Number of patients with Recurrent AKI during the same hospitalization(1 year)