Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection (GARM-COVID19)
Pulmonary Alveolar Proteinosis, COPD, Idiopathic Pulmonary Fibrosis
About this trial
This is an interventional treatment trial for Pulmonary Alveolar Proteinosis
Eligibility Criteria
Inclusion Criteria:
- Must have confirmed and documented Coronaviral (COVID-19) infection history with involvement of lung tissues
- Must be clear of any viral shed residual confirmed by negative viral testing protocol accepted by the Center for Disease Control (CDC) and/or the FDA
- Must have discharge confirmation from infectious disease managing Provider declaring freedom of viral load or active infection
- Must have a written Medical History of Physical and discharge summary (if hospitalized) from appropriate Center or Licensed Medical Provider
- Must agree to provide a HRCT LUNG study done at baseline (before), 3 months and 6 months
- Must be able to provide full Informed Consent (ICF)
Exclusion Criteria:
- Active or positive testing of COVID-19 With Clinical Report and Discharge Summary from Hospital or Treatment Facility
- Lung disorder without prior confirmation by approved test protocol of history of COVID-19
- Patient health or condition deemed dangerous or inappropriate for transport, exceeding acceptable stress for transport or care needed to achieve access to the clinical facility, at the discretion of the Providers
- Expected lifespan of < 6 months
- Serious of life threatening co-morbidities, that in the opinion of the investigators, may compromise the safety or compliance with the study guidelines and tracking
Sites / Locations
- Robert W. Alexander, MD, FICS, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Other
Other
Lipoaspiration
Isolation & Concentration of cSVF
Delivery cSVF via Intravenous
Liberase TM
Sterile Normal Saline
Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue
Isolation & Concentration of cellular stromal vascular fraction (cSVF) using Healeon Centricyte 1000 Centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocols
cSVF from Arm 2 is suspended in a 250 cc of sterile Normal Saline IV solution and deployed though 150 micron in-line filtration and intravenous route over 30-60 minute timeframe
Use of sterile Liberase TM enzyme to allow cSVF separation and isolation
250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV