cSVF Therapy for Post-COVID Lung Damage (GARM-COVID19 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Black Tie Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people who had COVID-19 and now have lasting lung damage. They must have a confirmed history of COVID-19 with lung involvement, no current virus detected, and be able to give informed consent. They should also agree to lung scans before, at 3 months, and at 6 months post-treatment.

Treatment Details

The study tests the use of a patient's own stromal vascular fraction (cSVF) cells given through an IV to see if they can reduce inflammation and repair damaged lung tissue. This Phase 0 trial is the first time this treatment is being tried in humans.

5Treatment groups

Experimental Treatment

Group I: Sterile Normal SalineExperimental Treatment2 Interventions

250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV

Group II: LipoaspirationExperimental Treatment1 Intervention

Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue

Group III: Liberase TMExperimental Treatment2 Interventions

Use of sterile Liberase TM enzyme to allow cSVF separation and isolation

Group IV: Isolation & Concentration of cSVFExperimental Treatment2 Interventions

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

Group V: Delivery cSVF via IntravenousExperimental Treatment2 Interventions

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