Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE
研究概览
简要总结
The trial evaluates the safety and efficacy of one and two doses of the study drug, Allocetra-OTS, in patients who have been diagnosed with sepsis.
详细描述
The study drug, Allocetra-OTS is a cell-based therapeutic composed of donor apoptotic cells. The product contains allogeneic mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The study drug, Allocetra-OTS, is based on the known activity of apoptotic cells to contribute to maintenance of peripheral immune homeostasis. As altered immune response is associated with organ dysfunction in sepsis, the possibility is being tested that the study drug can improve the condition of sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected, presumed or documented infection from any source.
- •Initiation of antibiotics.
- •Meets Sepsis 3 criteria: The presence of organ dysfunction as identified by a total SOFA score ≥ 2 points above baseline.
- •Adult male or female, age between 18 and
- •GCS of >13 with verbal score of
- •Signed written informed consent by the patient.
排除标准
- •Participation in an interventional investigational trial within 30 days prior to diagnosis of sepsis.
- •Significant trauma requiring hospitalization within 30 days prior to diagnosis of sepsis.
- •Surgical intervention or hospitalization within 45 days prior to diagnosis of sepsis.
- •Pregnancy or breast-feeding female.
- •Progressive or poorly-controlled malignancies or < 6 month after active treatment for cancer (chemotherapy or irradiation).
- •Terminally ill patients defined as patients that prior to the current hospitalization are expected to live < 6 months (as assessed by the physician responsible for the patient).
- •Known active acute or chronic viral infections, e.g. Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) or other chronic infection.
- •Known severe chronic respiratory health problems with severe pulmonary hypertension (≥40 mmHg) or respirator dependency.
- •Known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to: biopsy-proven cirrhosis; portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
- •Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within six months prior to diagnosis of sepsis.
- •Known immunocompromised state or medications known to be immunosuppressive.
- •Organ allograft or previous history of stem cell transplantation
结局指标
主要结局
Assessment of safety by determining the number of participants with any Adverse Events (AE),Serious Adverse Events (SAE) and fatal SAE
时间窗: 28 days follow up
Incidence rates of any Adverse Events (AE), Serious Adverse Events (SAE) and fatal SAE
次要结局
- Organ function or support measurements(28 days follow up)
- Mortality(28 days follow up)
- Hospitalization(28 days follow up)
- CRP(28 days follow up)
- Lactate levels(28 days follow up)