COVID-19 Stem Cell Therapy: A Phase I Study of Intravenous Administration of Allogeneic Adipose Stem Cells
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
- Frequency of all adverse events
研究概览
简要总结
This study is designed rapidly assess safety and preliminary efficacy in hospitalized patients with COVID-19 respiratory distress to provide clinical guidance for possible wider use in treating patients in this pandemic environment. This data will be used for FDA IND filings and pursuit of a BLA.
详细描述
This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients.
Study Objectives:
Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 disease and respiratory distress.
Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to hospital as in-patient (ward or ICU)
- •Respiratory distress - respiratory rate ≥ 30/minute (or PaO2:FiO2 <300)
- •Bilateral lung infiltrates (CT or frontal X-ray)
- •Supplemental oxygen started but NOT intubated or ventilated
- •COVID-19 (SARS-CoV-2) antigen test positive (FDA-approved test);
- •CDC confirmation not necessary
- •Time from Enrollment to treatment must be less than 24 hours
- •Age: 18-80 years
- •Gender: any
- •Suitability for cellular therapy: In the opinion of the Investigator or the Sponsor the patient is suitable for cellular therapy
- •Cognitive function: Able to understand and willing to sign informed consent form or legally authorized representative or surrogate
排除标准
- •Intubation / ventilation
- •Current therapy is working, and patient is clinically improving
- •Disease Conditions: Heart failure severe (NY Heart Association Classification IV); Clinical evidence of left heart failure or volume overload as a primary explanation for the bilateral pulmonary infiltrates; Any disease or condition other than current respiratory COVID-19 disease for which 6-month mortality is estimated to be greater than 50%; Moderate to severe liver failure; Severe chronic respiratory disease or the use of home oxygen use prior to this current illness; Currently receiving extracorporeal life support (ECLS/ECMO)
- •Past Disease Conditions: Any history of malignancy within the last 2 years (except for patients in remission or cured of the malignancy); Lung transplant patient or lobectomy; Deep venous thrombosis or pulmonary embolism within past 3 months; History of splenectomy
- •Other Experimental Conditions: Currently enrolled or treated in last 60 days in another clinical study
- •Consent Issues: Do not resuscitate (DNR) order in place; Not willing to follow lung protective ventilation strategy, if needed
- •Concurrent disease or circumstances that Investigator or Sponsor judges to be an unacceptable risk to patient health or a confounding variable to assessment or problem in completion of trial.
结局指标
主要结局
Frequency of all adverse events
时间窗: Through study completion, an average of three months
Frequency of all reported adverse events in study
Frequency of serious adverse events
时间窗: Through study completion, an average of three months
Frequency of all serious adverse events in study
Frequency of infusion related serious adverse events
时间窗: 6 hours post infusion
Frequency of SAEs in the 6 hours post-infusion for each infusion
次要结局
- Mortality(Study days 0-28)
- ICU Free Days(Days 0 through 28)
- Total ICU Days(Days 0 through discharge, an average of 28 days)
- Ventilator Free Days(Study days 0-28)
- Total Hospital Days(Days 0 through discharge, an average of 28 days)
- Improvement in Oxygenation(Study days 0, 2, 4, 6)