Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection (GARM-COVID19)

February 21, 2023 updated by: Black Tie Medical, Inc.

Use of cSVF For Residual Lung Damage (COPD/Fibrotic Lung Disease After Symptomatic COVID-19 Infection For Residual Pulmonary Injury or Post-Adult Respiratory Distress Syndrome Following Viral (SARS-Co-2) Infection

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Stevensville, Montana, United States, 59870
        • Robert W. Alexander, MD, FICS, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lipoaspiration
Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue
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
Experimental: Isolation & Concentration of cSVF
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
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
Drug: Liberase Enzyme (Roche)
Sterile Collagenase Blend to separate cSVF from the AD-SVF
Other Names:
  • Proteolytic Emzyme
Experimental: Delivery cSVF via Intravenous
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
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: 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 Names:
  • Suspensory Fluid for cSVF
Other: Liberase TM
Use of sterile Liberase TM enzyme to allow cSVF separation and isolation
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
Drug: Liberase Enzyme (Roche)
Sterile Collagenase Blend to separate cSVF from the AD-SVF
Other Names:
  • Proteolytic Emzyme
Other: Sterile Normal Saline
250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV
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: 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 Names:
  • Suspensory Fluid for cSVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 1 month
Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Function Analysis
Time Frame: baseline, 3 Month, 6 months
High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics
baseline, 3 Month, 6 months
Digital Oximetry
Time Frame: 3 months, 6 months
Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Black Tie Medical, Inc.

Collaborators

Robert W. Alexander, MD

Investigators

  • Study Chair: Robert W Alexander, MD, Global Alliance Regenerative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2020

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GARM COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In discussion phase

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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