COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary alveolar structure and functionality. A short review includes: - Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and was reported to the World Health Organization (WHO) Country Office. - January 30th, 2020 - The outbreak was declared a Public Health Emergency of International Concern. - February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like coronavirus) dies from the same virus. - February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19. - February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which were complicated with loss of lives.. - March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from the time when this virus was first detected, the virus has spread across the entire planet with cases identified in every country including Greenland. - March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more mildly affected areas. The elevated death risk estimates are probably associated with a breakdown of the healthcare system, indicating that enhanced public health interventions, including social distancing and movement restrictions, should be implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the United States is currently under some form of self- or mandatory quarantine as testing abilities ramp up.. March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New York-New Jersey, Washington, and California. Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical trials for drug testing started, and work on a long-term vaccine started. The recovering patients are presenting with mild to severe lung impairment as a result of the viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary function appears to be a permanent finding as a direct result of the interstitial lung damage and inflammatory changes that accompanied. This Phase 0, first-in-kind for humans, is use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanent damaged alveolar tissues of the lungs.
COVID-19 Viral Global Pandemic resulting in post-infection pulmonary damage, including
Fibrotic Lung Disease due to inflammatory and reactive protein secretions damaging pulmonary
alveolar structure and functionality. A short review includes:
- Early December, 2019 - A pneumonia of unknown cause was detected in Wuhan, China, and
was reported to the World Health Organization (WHO) Country Office.
- January 30th, 2020 - The outbreak was declared a Public Health Emergency of
International Concern.
- February 7th, 2020 - 34-year-old Ophthalmologist who first identified a SARS-like
coronavirus) dies from the same virus.
- February 11th, 2020 - WHO announces a name for the new coronavirus disease: COVID-19.
- February 19th, 2020 - The U.S. has its first outbreak in a Seattle nursing home which
were complicated with loss of lives..
- March 11th, 2020 - WHO declares the virus a pandemic and in less than three months, from
the time when this virus was first detected, the virus has spread across the entire
planet with cases identified in every country including Greenland.
- March 11th, 2020 - As of this date, Over 60% of all COVID-19 deaths in the U.S. can be
traced to that single nursing home in Seattle.
- March 11th, 2020 - Dr. Fauci from the National Institutes of Health (NIH) states, "If
you count all the estimated cases of people who may have it but haven't been diagnosed
yet, the mortality rate is probably closer to 1%," he said, "which means it's 10 times
more lethal than the seasonal flu."
- March 21st, 2020 - The U.S. has 24,105 active cases, 301 deaths, and 171 patients
declared recovered, a number which has since massively increased within the United
States and Globally.
- March 21st, 2020 - Emerging Infectious Disease estimates the risk for death in Wuhan
reached values as high as 12% in the epicenter of the epidemic and ≈1% in other, more
mildly affected areas. The elevated death risk estimates are probably associated with a
breakdown of the healthcare system, indicating that enhanced public health
interventions, including social distancing and movement restrictions, should be
implemented to bring the COVID-19 epidemic under control." March 21st 2020 -Much of the
United States is currently under some form of self- or mandatory quarantine as testing
abilities ramp up..
March 24th, 2020 - Hot spots are evolving and identified, particularly in the areas of New
York-New Jersey, Washington, and California
Immediate attention is turned to testing, diagnosis, epidemiological containment, clinical
trials for drug testing started, and work on a long-term vaccine started.
The recovering patients are presenting with mild to severe lung impairment as a result of the
viral attack on the alveolar and lung tissues. Clinically significant impairment of pulmonary
function appears to be a permanent finding as a direct result of the interstitial lung damage
and inflammatory changes that accompanied.
This Phase 0, first-in-kind for humans, is use of autologous, cSVF deployed intravenously to
examine the anti-inflammatory and structural potential to improve the residual damaged
tissues.
Previous utilization of cSVF remains in Clinical Trials at this moment for uses in Chronic
Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrotic Lung disorders,
showing encouraging safety profile and clinical efficacy. It is the intention of this study,
driven by the ongoing pandemic as a direct causative etiology for permanent lung damage
within the oxygen/carbon dioxide exchange resulting the the direct alveolar disruption and
scarring reaction.
The inflammatory mediation, autoimmune modulatory capabilities, and revascularization
potentials of the cSVF is becoming well recognized and documented in peer-reviewed literature
and in scientific studies.
Due to the urgency presented from the ongoing CoronaVirus pandemic, many patients that
survive experience demonstrate direct pulmonary damage residua. There is available a relative
new technology offered by Fluidda Inc in European Union (EU) known as "Functional Respiratory
Imaging (FRI) and examines pulmonary function and vascular capabilities in damaged lung
tissues. This study examines the lung baseline (post-infection), and at 3 and 6 month
intervals post-cSVF treatment to examine the functional airway configuration and efficiency
at those intervals.
Sporadic reports of use of stem cells or stem/stromal cells have revealed some positive
clinical outcomes, although not within a traditional randomized trial format at this point in
time. This study proposed in the specific situation of permanent residual dysfunction created
by the SARS-Co2 (Coronavirus) infection is felt to warrant a pilot study using the cSVF that
is in current Clinical Trials, which, at this point presents a very good safety profile with
the absence of adverse event (AE) or severe adverse events (SAE) as yet reported by the
trials.
Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)
Use of Disposable Microcannula Closed System (Tulip Med, 2.2 mm) Harvest of Autologous Adipose Stroma and Stem/Stromal Cell Content
Device: Centricyte 1000
Centricyte 1000 (Healeon Medical) Digestive (sterile Roche Liberase TM) Isolation/Concentration Protocol, Rinsing/Neutralization, and Pelletize the cSVF For Deployment Via Sterile Saline IV fluid Standard Protocol
Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution
Sterile Normal Saline Suspension cSVF in 250cc for Intravenous Delivery Including Use of 150 micron in-line filtration
Drug: Liberase Enzyme (Roche)
Sterile Collagenase Blend to separate cSVF from the AD-SVF
Other Name: Proteolytic Emzyme
Drug: Sterile Normal Saline for Intravenous Use
Sterile Normal Saline IV solution to provide suspension of cSVF in 250 cc via standard IV line, including sterile 150 micron in-line standard filter
Other Name: Suspensory Fluid for cSVF
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
Robert W. Alexander, MD, FICS, LLC
Stevensville, Montana, United States
Robert W Alexander, MD, Study Chair
Global Alliance Regenerative Medicine