Adipose-Derived Stromal Vascular Fraction Cell Therapy to Treat Post COVID-19 Respiratory Distress - An Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Safety- adverse events
研究概览
简要总结
This study is an early feasibility study to evaluate the safety of a single intravenous injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of continuing respiratory distress after recovery from COVID-19.
详细描述
The GID SVF-2 device is indicated for use for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of continuing respiratory distress after recovery from COVID-19.
The primary objective of this study is to evaluate the safety of a single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from initial COVID-19 infection.
The secondary objective is preliminary assessment of feasibility of a single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from COVID-19.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects that are ambulatory and previously hospitalized for a confirmed diagnosis of COVID-19 using RT-PCR test
- •Male or female subjects between the ages of 18-75
- •SpO2 > 92% on room air
- •Subjects with BMI ≥22
- •Subjects with Forced Vital Capacity (FVC) ≥ 40% predicted and ≤ 70% predicted
- •Subjects with DLCO ≥ 20% predicted and ≤ 70% predicted
- •Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study before any study procedures are performed
- •Subjects with the ability to speak, read and understand English
- •Subjects with the ability to complete follow up as specified in the protocol
排除标准
- •Subjects taking immunosuppressive drugs
- •Subjects with history of lung malignancy
- •Subjects allergic to lidocaine or epinephrine
- •Women that are pregnant or planning to become pregnant during the study
- •Women that are lactating
- •Women on hormonal contraceptives in the past 30 days
- •Women currently on hormone replacement therapy
- •Subjects with chronic kidney disease Stage 4 and Stage 5
- •Subjects with a history of pulmonary embolism
- •Subjects with a history of anti-phospholipid syndrome
- •Subjects participating in any other clinical study
- •Subjects with history of deep vein thrombosis
- •Subjects with history of Cirrhosis with Pugh classification of B or C
- •Subjects on hemodialysis
- •Subjects with organ dysfunction or predisposed to organ dysfunction (i.e., pre-dialysis & orthopnea)
- •Subjects with a history of prior clotting disorders or thrombotic syndrome
- •Subjects with myocardial infarction within the past 2 months
- •Subjects with blood pressure <85/50 mmHg or >160/100 mmHg or mean arterial pressure <60 mmHg or >120 mmHg
- •Subjects with a history of drug or alcohol abuse
- •Pulse <50 bpm or >140 bpm
- •Cardiac rhythm showing rapid atrial fibrillation with heart rate >120 bpm or ventricular tachycardia
研究组 & 干预措施
Open Label Treatment Arm
A single intravenous injection of autologous adipose-derived SVF for treatment of continuing respiratory distress after recovery from COVID-19 for reintroduction to the same patient during a single surgical procedure.
干预措施: GID SVF-2 Device System (Device)
结局指标
主要结局
Safety- adverse events
时间窗: Baseline to 3 months post treatment
Evaluation of type and frequency of adverse events.
次要结局
- Pulmonary Function - Carbon Monoxide diffusing Capacity(Baseline to 3 months post treatment)
- Pulmonary Function - SpO2(%)(Baseline to 3 months post treatment)
- Pulmonary Function - Forced Vital Capacity(Baseline to 3 months post treatment)