Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
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.