Clinical Study on the Safety and Preliminary Efficacy of Umbilical Cord Mesenchymal Stem Cell Intravenous Infusion Therapy for Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
研究概览
简要总结
The object of this study is to observe the safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome, consisting with two phases.
详细描述
The secondary objectives are to observe the preliminary efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome. Phase One is an open-label, dose-escalation clinical study. Following safety and tolerability conclusions from Phase One, and upon evaluation and approval by the data safety committee and ethics committee, conduct Phase Two study, which will be a randomized, double-blind, placebo-controlled study. Dosage selection will be based on the safest and most effective dosage determined from Phase One results.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years, regardless of gender;
- •Meeting the ARDS Berlin diagnostic criteria;
- •Definite diagnosis within 72 hours;
- •P/F < 150mmHg;
- •Understanding and signing informed consent.
排除标准
- •Women of childbearing potential with a positive serum pregnancy test before medication, pregnant women, or lactating women;
- •ARDS directly caused by physical or chemical factors;
- •Moderate to severe liver damage (Child-Pugh score >12);
- •Chronic heart failure, New York Heart Association functional class IV;
- •Severe kidney disease undergoing renal replacement therapy;
- •Severe lung disease, Grade III or IV pulmonary hypertension, receiving oxygen therapy or ventilator support for more than one month in the six months prior to screening, end-stage lung disease, or severe physical limitations due to chest wall deformity;
- •Immunodeficiency, receiving immunosuppressive therapy within 2 weeks (except for low-dose corticosteroids), or with lymphoma, leukemia, or acquired immune deficiency syndrome; history of organ transplantation, bone marrow transplantation, or autologous hematopoietic stem cell suppression;
- •Expected survival time of less than 48 hours due to terminal illness;
- •Patients diagnosed with deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past three months;
- •Patients receiving ECMO therapy;
- •Hepatitis B, hepatitis C, syphilis, or HIV infection.
- •eGFR < 30ml/min/BSA;
- •ALT > 5 × ULN;
- •Absolute neutrophil count < 1500/μL;
- •Subjects who have participated in other clinical studies within the past month (excluding those who have not received intervention), or are currently participating in other experimental treatments;
- •Subjects deemed unlikely to benefit from the study by the investigator, or deemed unsuitable for participation in this study.
研究组 & 干预措施
placebo
1 intravenous infusion of an equal volume of cell-free placebo.
干预措施: Placebo (Drug)
MSC
Name：Human umbilical cord mesenchymal stem cells Specification: 30 ml/bag Dosage: 1×106cells/kg, 5×106cells/kg, 10×106cells/kg Usage: Intravenous infusion The stem cells used in this study are human umbilical cord mesenchymal stem cells (hUC-MSCs), which are derived from umbilical cords donated by healthy mothers who have given birth in maternity hospitals. hUC-MSCs are extracted, processed, cultured and harvested from umbilical cord donors recruited by laboratories complying with the GMP standards. hUC-MSCs cell suspensions that have passed the quality control will be put into bags and transported to the hospitals for use by the subjects of the present clinical study.
干预措施: umbilical cord mesenchymal stem cell (Drug)
结局指标
主要结局
The safety of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.
时间窗: The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.
The 28-day mortality of patients receiving umbilical cord mesenchymal stem cell therapy
次要结局
- The efficacy of umbilical cord mesenchymal stem cell therapy for acute respiratory distress syndrome.(The 1, 6, 24 hours; 3、7、14、21 days and 4, 12, 24, 36, 48 weeks after injection.)
研究者
Jianfeng Xie
deputy director
Southeast University, China