Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Patients alive without grade 3, 4 infusional toxicity (Phase II)
研究概览
简要总结
This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.
详细描述
PRIMARY OBJECTIVE:
1. To assess the safety of administering cord blood derived mesenchymal stem cell (CB-MSC) infusions for treatment of moderate, severe or critical pneumonia.
SECONDARY OBJECTIVES:
- In the group of participants who present intubated on ventilator support, assess the proportion that are able to be successfully extubated.
- In the group of participants who present requiring supplemental oxygen but otherwise breathing without assistance, assess the rate of progression to intubation.
- Estimate the survival rate at day 30 post treatment separately by group.
- Determine the treatment effect on clinical parameters, oxygenation and respiratory parameters:
- Resolution of fever
- Changes in oxygen demand (increased oxygen saturation at similar FiO2 or decreased FiO2 requirement)
- Progression to mechanical ventilation
- Length of Mechanical ventilation
- Decrease in PEEP in intubated participants
- Decrease in FiO2 in intubated participants
- Determine the treatment effect on laboratory markers:
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
- None
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 or equal 18 years.
- •Participants with chest x-ray findings concerning for pneumonia from any cause, with clinical signs suggestive of at least moderate illness such as respiratory rate >20 breaths per minute or with oxygen saturation less than 93% on room air**
- •Participants with COVID-19 associated pneumonia must meet baseline categorization of Moderate, Severe or Critical COVID-19 per FDA Guidance for Industry COVID-19: Developing Drugs and Biologics Products for Treatment or Prevention, February
- •Negative pregnancy test in a woman with childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- •Participant or legally authorized representative consent. Participants with diminished mental capacity may be allowed on to enroll on the study.
- •Because of the nature of COVID-19, participants enrolled on this study with COVID-19 associated pneumonia may have been previously enrolled in other IND trials for their cancer diagnosis or for COVID-
- •These enrollments will not exclude them from enrollment to this study.
排除标准
- •Moribund participants not expected to survive up to 48 hours
- •Participants with severe chronic liver disease (Childs-Pugh score > 10)
- •Pregnant and/or lactating women
- •Participants on extracorporeal membrane oxygenation
研究组 & 干预措施
Phase II Arm II (standard of care)
Patients receive standard of care.
干预措施: Best Practice (Other)
Phase II Arm I (mesenchymal stem cells)
Patients receive MSCs as in the Pilot study.
干预措施: Mesenchymal Stem Cell (Biological)
Pilot study (mesenchymal stem cells)
Patients receive MSCs IV over 1-2 hours on day 1. Patients may receive a second infusion of MSCs within 7 days after the first infusion per physician discretion.
干预措施: Mesenchymal Stem Cell (Biological)
结局指标
主要结局
Patients alive without grade 3, 4 infusional toxicity (Phase II)
时间窗: At day 30 post MSC infusion
Patients alive with grade 3 or 4 infusional toxicity (Phase II)
时间窗: At day 30 post MSC infusion
Incidence of composite serious adverse events (Phase I)
时间窗: Within 30 days of the first mesenchymal stem cell (MSC) infusion
Serious adverse events with be comprised of grade 3 or 4 graft versus host disease or death and will be estimated and reported overall and by group, along with 95% confidence intervals.
Patients not alive (Phase II)
时间窗: At day 30 post MSC infusion
次要结局
- Hospitalization stay (Phase I)(Up to day 30 post MSC infusion)
- Proportion of successfully extubated patients who present intubated on ventilator support (Phase I)(Up to day 30 post MSC infusion)
- Intensive care unit stay (Phase I)(Up to day 30 post MSC infusion)
- Rate of successful progression to intubation in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)(Up to day 30 post MSC infusion)
- Overall survival rate (Phase I)(At day 30 post MSC infusion)
- Survival rate in patients who present intubated on ventilator support (Phase I)(At day 30 post MSC infusion)
- Survival rate in patients who require supplemental oxygen but who are otherwise able to breathe without assistance (Phase I)(At day 30 post MSC infusion)
- Clinical parameters (Phase I)(Up to day 30 post MSC infusion)
- Respiratory parameters (Phase I)(Up to day 30 post MSC infusion)
- Oxygenation parameters (Phase I)(Up to day 30 post MSC infusion)
- Laboratory markers (Phase I)(Up to day 30 post MSC infusion)
- Incidence of infusion-related adverse events (Phase I)(Up to day 30 post MSC infusion)