NCT04447833进行中（未招募）1 期
Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome Validation of Mechanistic Pathways and Clinical Efficacy
Uppsala University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年6月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The incidence of pre-specified treatment related adverse events of interest (TRAEIs).
研究概览
简要总结
This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used synonymously in this protocol) support due to respiratory insufficiency with or without concomitant circulatory problems, will be included and treated with a single dose of KI-MSC-PL-205.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent prior to performing study procedures (and have given written consent)
- •Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test at screening
- •Male or female patient aged 18 to 65 years old
- •Patient must fulfil the Berlin Definition of severe ARDS within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
- •Patient is on respirator support within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
- •Pregnancy test in blood confirming negative results before enrolment (for women ≤55 years old)
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
- •Patients with history of treated blood and/or solid organ malignancy with recurrence within five years prior to dosing of the ATIMP are to be excluded. Patients with history of cervix cancer and non-melanoma skin cancer with recurrence within two years prior to dosing of the ATIMP are to be excluded
- •Pregnant or breast feeding female
- •Patient with a history of anti-coagulation therapy for other indications that short-term prophylaxis after surgery
- •Patients with a history and/ or on-going treatment for entity associated with bleeding disorder or potential risk for bleeding (e.g. inflammatory bowel disease, gastro-esophagitis with or without ulcers, haemophilia and other bleeding disorders, inflammatory musculo-skeletal disease with potential bleeding complications)
- •Patients with a history during the latest five years and/or on-going treatment for systemic infection (e.g. Septicaemia due to in vivo foreign body (e.g. stents, catheters, heart valve), tuberculosis, malaria, other opportunistic and parasite infections)
- •Any other irreversible disease or condition for which six-month mortality is estimated to be greater than 50%
- •Moderate to severe liver failure (Child-Pugh Score >12)
- •Reduced renal function with a creatinine clearance (Cockcroft-Gault Equation) < 45 mL/min/1.73m2
- •Severe chronic respiratory disease with a PaCO2 >50 mmHg or the use of home oxygen
- •Major trauma in the prior 5 days
- •Lung transplant patient
- •Patients on ECMO-support
- •Patients with a previous history of severe burns
- •Documented deep venous thrombosis or pulmonary embolism within past three months
- •Known hypersensitivity to DMSO
- •Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements
研究组 & 干预措施
Mesenchymal Stromal Stem Cell Treatment
Experimental
Infusion of allogeneic bone marrow derived mesenchymal stromal stem cells (MSC). First three patients receive a singe dose of 1x10^6 MSC/kg dose, next six patients receive a single dose of 2x10^6 MSC/kg.
干预措施: Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 (Drug)
结局指标
主要结局
The incidence of pre-specified treatment related adverse events of interest (TRAEIs).
时间窗: From drug administration to day 10 post-infusion
The incidence of pre-specified treatment related adverse events of interest (TRAEIs) occurring during the 10 days interval beginning with the start of the ATIMP infusion: * New ventricular tachycardia, ventricular fibrillation or asystole within 10 days after infusion * New cardiac arrhythmia requiring cardioversion within 10 days after infusion * Clinical scenario consistent with transfusion incompatibility or transfusion-related infection within 10 days after infusion * Thromboembolic events (e.g. Pulmonary embolism) within 10 days after infusion * Cardiac arrest or death within 10 days after infusion
次要结局
- Safety; All-cause mortality(60 days post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in Leucocytes(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in Trombocytes(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in plasma concentration of Aspartate amino transferase (ASAT)(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in Body temperature(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in plasma concentration of Prothrombin complex (PK)(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in plasma concentration of Alanine amino transferase (ALAT)(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in Blood pressure(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Efficacy; Pulmonary bilateral infiltrates(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in Quality of life(6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Efficacy; Sequential Organ Failure Assessment (SOFA) score(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, end of ICU)
- Lung fibrosis(Baseline (pre-infusion), day 1, 3, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Sensitisation test(Baseline (pre-infusion), day 60 post-infusion)
- Changes in plasma concentration of C-reactive protein (CRP)(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in plasma concentration of Creatinine(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Changes in plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP)(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Efficacy; Changes in oxygenation (PaO2/FiO2)(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion)
- Lung function(Day 60 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Six minutes walk test(6 months, 1, 2, 3, 4 and 5 years post-infusion)
- Efficacy; Changes in pulmonary compliance(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion)
- Efficacy; Changes in driving pressure (Plateau pressure- PEEP)(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion)
- Efficacy; Duration of ventilator support(Baseline (pre-infusion),day 1, 2, 3, 4, 7, 10 and 60 post-infusion)
- Efficacy; Hospital stay(Day 60 post-infusion)
- Blood biomarkers(Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion)
研究者
研究点 (1)
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