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: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Black Tie Medical, Inc.; Healeon Medical Inc
• Collaborator: Robert W. Alexander, MD
• Treatments: Pharmaceutical Solutions

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