Allogeneic Adipose-derived Mesenchymal Stem Cells (MSC) for Acute Kidney Injury After Trauma or Burn
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 5
- 主要终点
- Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Placebo
Normal saline
干预措施: Normal Saline (Drug)
Treatment
Allogeneic adipose-derived HB-adMSCs
干预措施: Allogeneic HB-adMSCs (Drug)
结局指标
主要结局
Incidence of infusion-related adverse events (AEs) or serious adverse events (SAEs)
时间窗: 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
时间窗: 2 days
Proportion of patients with a duration of Stage 2 AKI more than 2 days after the start of treatment
次要结局
- 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)