IV Infusion of Autologous Adipose Derived Mesenchymal Cells for Abatement of Respiratory Compromise in SARS-CoV-2 Pandemic (COVID-19)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Efficacy - Changes in length of mechanical ventilation
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of autologous adipose-derived mesenchymal cells for treating confirmed or suspected patients with SARS-CoV-2 and compromised respiratory function requiring hospitalization.
The hypothesis of the Study is autologous adipose-derived mesenchymal cells given IV to eligible patients will improve clinical outcomes of COVID 19 positive patients with severe pneumonia or ARDS by reducing or avoiding cytokine storm.
详细描述
While most patients with SARS-CoV-2 present with mild respiratory disease with the most common symptoms of fever and cough, approximately 14 % progress to severe pneumonia and ARDS.
The overall mortality rate is 2% but varies by country and age of the patient.
In COVID-19 ARDS standard supportive care and treatment for underlying illnesses remain the mainstay with limited success.
Numerous antiviral medications including remdesivir, lopinavir-ritonavir or lopinavir-ritonavir and interferon Beta-1a are in clinical trials but safety and efficacy remain unclear.
Inflammation associated with a cytokine storm begins at a local site and spreads throughout the body via systemic circulation. The lungs and other organs are damaged with progressive inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of and less than 90
- •COVID 19 diagnosis confirmed
- •Ability to give informed consent
- •Hospitalized
排除标准
- •Mild Illness
- •Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, or headache. Rarely, patients may also present with diarrhea, nausea and vomiting.
- •The elderly and immunosuppressed candidates may present with atypical symptoms. Symptoms due to physiologic adaptations of pregnancy or adverse pregnancy events, such as e.g. dyspnea, fever, GI-symptoms or fatigue, may overlap with COVID-19 symptoms. Still, they will be excluded, unless they progress to Inclusion Criteria within 72 hours from recruitment.
- •Pneumonia (uncomplicated):
- •a. Adults with pneumonia but no signs of severe pneumonia AND NO need for supplemental oxygen
- •Reported pregnant or positive pregnancy test
- •Other chronic respiratory disorders such as COPD, emphysema, lung cancer, or cystic fibrosis
- •BMI lower than 21
- •Skinfold test < 3 cm at harvest area
- •Patients with Do-Not-Resuscitate orders that limit mechanical ventilation assistance in place at hospital admission
- •Males and females < 18 years of age
- •Patients who are currently breastfeeding
- •Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection viruses.
- •History of systemic malignant neoplasms within the last 5 years.
- •Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
- •Participating in another clinical research study
- •History of Bleeding disorder which in PI's opinion would render the patient unsuitable for the study
- •PT (plasma) < 9 or >11.6 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
- •PTT < 23 or >32 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
- •Platelets count less than 70,0000
- •History of DVT
结局指标
主要结局
Efficacy - Changes in length of mechanical ventilation
时间窗: up to 28 days
Changes in time subjects remain on mechanical ventilation
Efficacy - Changes in mortality rate
时间窗: up to 28 days
Mortality rate from all causes
Efficacy - Frequency of progression to mechanical ventilation
时间窗: up to 28 days
Changes in progression or rate of subjects progressing to mechanical ventilation
Safety - Incidence of unexpected adverse events
时间窗: up to 28 days
Incidence of unexpected adverse events within 28 days following IV administration of MSCs.
Efficacy - Changes in length of weaning of mechanical ventilation
时间窗: up to 28 days
Changes in length of time subjects wean off of mechanical ventilation
Efficacy - Changes in length of hospital stay
时间窗: up to 28 days
Length of Hospital Stay
次要结局
未报告次要终点