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

Официальное название

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

Обзор

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).

Подробное описание

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).

Вмешательства

• Препарат Allogeneic HB-adMSCs
  Allogeneic HB-adMSCs
• Препарат Normal Saline
  Sterile Saline Solution

Первичные конечные точки

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

Вторичные конечные точки (7)

• Number of patients with progression of Kidney Disease Improving Global Outcomes (KDIGO) Stage 2 AKI [Срок оценки: 1 year]
• Mortality at 30, 90 days and 365 days [Срок оценки: 1 year]
• Post-injury organ dysfunction and thromboinflammation [Срок оценки: 1 year]
• Number of participants with chronic critical illness (≥14 days) [Срок оценки: 1 year]
• Severity of complications, including incidence of sepsis, ARDS, venous thromboembolism (VTE; pulmonary embolism and deep venous thrombosis), and multiple organ failure (MOF) [Срок оценки: 1 year]
• Hospital-, ICU- and ventilator-free days [Срок оценки: 1 year]
• Number of patients with Recurrent AKI during the same hospitalization [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of Alabama at Birmingham — Birmingham
• University of California, San Francisco — San Francisco
• University of Texas Health Science Center at Houston (UTHealth Houston) — Houston

Идентификаторы

NCT: NCT06654193 · HBAKI01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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