Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection

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.

Conditions

• Pulmonary Alveolar Proteinosis
• COPD
• Idiopathic Pulmonary Fibrosis
• Viral Pneumonia
• Coronavirus Infection
• Interstitial Lung Disease

Interventions

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

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

Sponsors & Collaborators

• Robert W. Alexander, MD

  collaborator UNKNOWN

• Black Tie Medical, Inc.

  lead INDUSTRY

Principal Investigators

• Robert W Alexander, MD · Global Alliance Regenerative Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-25

Primary Completion

2023-08-01

Completion

2024-01-31

FDA Drug

Yes

Countries

• United States

Study Locations