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

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ClinicalTrials.gov Identifier: NCT04326036
Recruitment Status : Enrolling by invitation
First Posted : March 30, 2020
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
Robert W. Alexander, MD
Information provided by (Responsible Party):
Healeon Medical Inc

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

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Study Type : Interventional
Estimated 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 : March 25, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : December 31, 2021


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 Name: 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 Name: Suspensory Fluid for cSVF

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 Name: Proteolytic Emzyme

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 Name: Suspensory Fluid for cSVF




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 month ]
    Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0


Secondary Outcome Measures :
  1. 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

  2. Digital Oximetry [ Time Frame: 3 months, 6 months ]
    Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326036


Locations
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United States, Montana
Robert W. Alexander, MD, FICS, LLC
Stevensville, Montana, United States, 59870
Sponsors and Collaborators
Healeon Medical Inc
Robert W. Alexander, MD
Investigators
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Study Chair: Robert W Alexander, MD Global Alliance Regenerative Medicine
Publications:
Alexander, Robert W., Overview of Cellular Stromal Vascular Fraction (cSVF) & Biocellular Uses of Stem/Stromal Cells & Matrix (tSVF + HD-PRP) in Regenerative Medicine, Aesthetic Medicine and Plastic Surgery. 2019, S1003, DOI: 10.24966/SRDT-2060/S1003.
Alexander, Robert W., Understanding Adipose-Derived Stromal Vascular Fraction (AD-SVF) Cell Biology and Use on the Basis of Cellular, Chemical, Structural and Paracrine Components. (2012), J of Prolotherapy, 4: 855-869.

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Responsible Party: Healeon Medical Inc
ClinicalTrials.gov Identifier: NCT04326036    
Other Study ID Numbers: GARM COVID19
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In discussion phase

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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:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Pulmonary Alveolar Proteinosis
Pneumonia
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Idiopathic Interstitial Pneumonias