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

Sponsor
Black Tie Medical, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04326036
Collaborator
Robert W. Alexander, MD (Other)
10
1
5
34.2
0.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)
  • Device: Centricyte 1000
  • Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution
  • Drug: Liberase Enzyme (Roche)
  • Drug: Sterile Normal Saline for Intravenous Use
Early Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 25, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [1 month]

      Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0

    Secondary Outcome Measures

    1. Pulmonary Function Analysis [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

    2. Digital Oximetry [3 months, 6 months]

      Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert W. Alexander, MD, FICS, LLC Stevensville Montana United States 59870

    Sponsors and Collaborators

    • Black Tie Medical, Inc.
    • Robert W. Alexander, MD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Black Tie Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT04326036
    Other Study ID Numbers:
    • GARM COVID19
    First Posted:
    Mar 30, 2020
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2022