Department of Surgery, University of Washington, USAFulltext PDF
A Coronavirus (nCoV-2) has caused a worldwide pandemic, beginning in Wuhan, China. Patient’s acquiring viral infection (COVID-19) which is featured by elevation of temperature, cough, severe fatigue, and a variety of symptoms mimicking the flu and pneumonias. This gradually extended to a progressive and serious respiratory failure with associated ARDS and severe pneumonias with residual scarring of the interstitial areas of the lung alveoli, resulting in acute life-threatening, and permanent compromised gas exchange. Those that survive controlled ventilation (low tidal volumes), medical induced coma, and prone positioning, are often left with reduction in pulmonary function abilities. This paper reviews some pertinent knowledge and advances in understanding of the pulmonary injuries and long-term damage of the COVID-19 patients, and reports a study to ameliorate such damage with use of cSVF for those who successfully recover. There now exists technology to perform sophisticated analytics (Functional Respiratory Imaging, FRI) developed by Fluidda (Belgium, EU) which provides great detail and information, including the ability to help triage the infected patients early to help assist in prediction of ventilation and ICU needs. In addition, author’s experience with use in Chronic Obstructive Pulmonary Disease (COPD) and Fibrotic Lung Diseases, the ability to evaluate effectiveness of use of cellular Stromal Vascular Fraction (cSVF) following intravascular deployment of isolated and concentrated cSVF. The hypothesis is that reduction of the widespread pulmonary inflammatory and immune responses which destroy much of the gas exchange abilities in the acute and residual damage which appears to create a long-term problem in the surviving patient population. Fluidda imaging analytics are effective at predictive studies which may prove of great help in anticipating which patient group is at most risk in the earlier infections to require ICU and potential ventilation needs. The clinical trial involves standard sterile microcannula harvesting of the SVF (GEMS, Tulip Medical, USA), followed by isolation/concentration of the cSVF within a closed system with incubation, agitation of enzyme in Centricyte 1000 (Healeon Medical, Newbury Park, CA, USA). The cSVF is then re-suspended and slowly delivered via peripheral IV deployment using 150 micron in-line filters. Serial examinations using High Resolution Computerized Tomography Lungs (HRCT Lungs) at both Total Lung Capacity (TLC) and Functional Residual Capacity (FRC) at baseline and 3 month intervals. In addition, tracking of functional lung testing, and oxygen demands (if appropriate). Experiences and research confirms the ability of components of the SVF to assist in the modulation of inflammatory and immune responses, which now appear be some of the most threatening and damaging effects in the COVID-19 patient population. This is a Phase 0/I Clinical Trial (10 Patients), with the plan to follow up with a full randomized Phase I/II study.
Alexander RW. Overview of COVID-19 Lung Damage Clinical Trial Using Cellular Stromal Vascular Fraction (CSVF) and Functional Respiratory Imaging (FRI) Analysis of Pulmonary Injury & Post-Viral (SARS=Cov-2) Adult Respiratory Distress Syndrome (ARDS). Ann Stem Cell Res Ther. 2020;4(1):1039..