Pulmonary Alveolar ProteinosisEarly Phase 1GARM-COVID19NCT04326036
Use of cSVF Via IV Deployment for Residual Lung Damage After Symptomatic COVID-19 Infection
A Early Phase 1 study testing Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF), Centricyte 1000 and IV Deployment Of cSVF In Sterile Normal Saline IV Solution in people with Pulmonary Alveolar Proteinosis and COPD, run by Black Tie Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Alveolar Proteinosis, COPD, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF), Centricyte 1000 and IV Deployment Of cSVF In Sterile Normal Saline IV Solution
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 31 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert W. Alexander, MD, FICS, LLC
Stevensville, Montana, 59870
About this study
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
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..
Read more
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.
Read the 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.
- Conditions
- Pulmonary Alveolar Proteinosis, COPD, Idiopathic Pulmonary Fibrosis, Viral Pneumonia, Coronavirus Infection, Interstitial Lung Disease
- Being tested
- Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF), Centricyte 1000, IV Deployment Of cSVF In Sterile Normal Saline IV Solution, Liberase Enzyme (Roche), Sterile Normal Saline for Intravenous Use
- Medical subject headings
- Pulmonary Alveolar Proteinosis, Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Pneumonia, Viral, Coronavirus Infections, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)Procedure or surgery
Use of Disposable Microcannula Closed System (Tulip Med, 2.2 mm) Harvest of Autologous Adipose Stroma and Stem/Stromal Cell Content
Centricyte 1000Device
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
IV Deployment Of cSVF In Sterile Normal Saline IV SolutionProcedure or surgery
Sterile Normal Saline Suspension cSVF in 250cc for Intravenous Delivery Including Use of 150 micron in-line filtration
Liberase Enzyme (Roche)Drug
Also called Proteolytic Emzyme
Sterile Collagenase Blend to separate cSVF from the AD-SVF
Sterile Normal Saline for Intravenous UseDrug
Also called Suspensory Fluid for cSVF
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
| Study group | Role | What they receive |
|---|---|---|
| Lipoaspiration | Experimental | Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue Receives: Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF) |
| Isolation & Concentration of cSVF | Experimental | 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 Receives: Device: Centricyte 1000; Drug: Liberase Enzyme (Roche) |
| Delivery cSVF via Intravenous | Experimental | 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 Receives: Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Drug: Sterile Normal Saline for Intravenous Use |
| Liberase TM | Other | Use of sterile Liberase TM enzyme to allow cSVF separation and isolation Receives: Device: Centricyte 1000; Drug: Liberase Enzyme (Roche) |
| Sterile Normal Saline | Other | 250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV Receives: Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Drug: Sterile Normal Saline for Intravenous Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
Measured: 1 month
Secondary outcomes (2)
Pulmonary Function Analysis
High Resolution Computerized Tomography of Lung (HRCT Lung) for Fluidda Analysis comparative at baseline and 3 and 6 months post-treatment comparative analytics
Measured: baseline, 3 Month, 6 months
Digital Oximetry
Finger Pulse Oximetry taken before and after 6 minute walk on level ground, compare desaturation tendency
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start25 Mar 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Alveolar ProteinosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Black Tie Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alexander, Robert W., M.D.
- Responsible party
- Sponsor
- Investigators
- Robert W Alexander, MD, Study chair, Global Alliance Regenerative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326036
- Sponsor's protocol ID
- GARM COVID19
- Acronym
- GARM-COVID19
- Status last verified
- Feb 2023
- First submitted
- 26 Mar 2020
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: In discussion phase
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.
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
PubMed 32064853Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov. 2020 Mar;19(3):149-150. doi: 10.1038/d41573-020-00016-0. No abstract available.
PubMed 32127666Wu K, Peng G, Wilken M, Geraghty RJ, Li F. Mechanisms of host receptor adaptation by severe acute respiratory syndrome coronavirus. J Biol Chem. 2012 Mar 16;287(12):8904-11. doi: 10.1074/jbc.M111.325803. Epub 2012 Jan 30.
PubMed 22291007Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
PubMed 32015507Ding Y, He L, Zhang Q, Huang Z, Che X, Hou J, Wang H, Shen H, Qiu L, Li Z, Geng J, Cai J, Han H, Li X, Kang W, Weng D, Liang P, Jiang S. Organ distribution of severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV) in SARS patients: implications for pathogenesis and virus transmission pathways. J Pathol. 2004 Jun;203(2):622-30. doi: 10.1002/path.1560.
PubMed 15141376Kawase M, Shirato K, van der Hoek L, Taguchi F, Matsuyama S. Simultaneous treatment of human bronchial epithelial cells with serine and cysteine protease inhibitors prevents severe acute respiratory syndrome coronavirus entry. J Virol. 2012 Jun;86(12):6537-45. doi: 10.1128/JVI.00094-12. Epub 2012 Apr 11.
PubMed 22496216Zhang R, Pan Y, Fanelli V, Wu S, Luo AA, Islam D, Han B, Mao P, Ghazarian M, Zeng W, Spieth PM, Wang D, Khang J, Mo H, Liu X, Uhlig S, Liu M, Laffey J, Slutsky AS, Li Y, Zhang H. Mechanical Stress and the Induction of Lung Fibrosis via the Midkine Signaling Pathway. Am J Respir Crit Care Med. 2015 Aug 1;192(3):315-23. doi: 10.1164/rccm.201412-2326OC.
PubMed 25945397
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04326036
- Acronym / sponsor ID
- GARM-COVID19 / GARM COVID19
- Conditions
- Pulmonary Alveolar Proteinosis, COPD, Idiopathic Pulmonary Fibrosis, Viral Pneumonia, Coronavirus Infection, Interstitial Lung Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Black Tie Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alexander, Robert W., M.D.
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lipoaspiration | Experimental | Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)Closed sterile, disposable microcannula of small volume adipose tissue, including the stromal vascular fraction (SVF) (cells and stromal tissue |
| Isolation & Concentration of cSVF | Experimental | Device: Centricyte 1000, Drug: Liberase Enzyme (Roche)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 |
| Delivery cSVF via Intravenous | Experimental | Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution, Drug: Sterile Normal Saline for Intravenous UsecSVF 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 |
| Liberase TM | Other | Device: Centricyte 1000, Drug: Liberase Enzyme (Roche)Use of sterile Liberase TM enzyme to allow cSVF separation and isolation |
| Sterile Normal Saline | Other | Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution, Drug: Sterile Normal Saline for Intravenous Use250 cc of sterile Normal Saline for Intravenous with sterile 150 micron in-line filtration for suspension of the concentrated cSVF and deployment IV |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Lipoaspiration |
| Centricyte 1000Centricyte 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 | Device | Isolation & Concentration of cSVF, Liberase TM |
| IV Deployment Of cSVF In Sterile Normal Saline IV SolutionSterile Normal Saline Suspension cSVF in 250cc for Intravenous Delivery Including Use of 150 micron in-line filtration | Procedure or surgery | Delivery cSVF via Intravenous, Sterile Normal Saline |
| Liberase Enzyme (Roche)Also: Proteolytic EmzymeSterile Collagenase Blend to separate cSVF from the AD-SVF | Drug | Isolation & Concentration of cSVF, Liberase TM |
| Sterile Normal Saline for Intravenous UseAlso: Suspensory Fluid for cSVFSterile Normal Saline IV solution to provide suspension of cSVF in 250 cc via standard IV line, including sterile 150 micron in-line standard filter | Drug | Delivery cSVF via Intravenous, Sterile Normal Saline |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 month
Reporting of Adverse Events or Severe Adverse Events Assessed by CTCAE v4.0
2 secondary outcomes
Pulmonary Function Analysis
Time frame: baseline, 3 Month, 6 months
Digital Oximetry
Time frame: 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- BackgroundAlexander, 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.
- BackgroundAlexander, 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.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 32064853Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese.
- Background: PubMed 32127666Li G, De Clercq E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nat Rev Drug Discov. 2020 Mar;19(3):149-150. doi: 10.1038/d41573-020-00016-0. No abstract available.
- Background: PubMed 22291007Wu K, Peng G, Wilken M, Geraghty RJ, Li F. Mechanisms of host receptor adaptation by severe acute respiratory syndrome coronavirus. J Biol Chem. 2012 Mar 16;287(12):8904-11. doi: 10.1074/jbc.M111.325803. Epub 2012 Jan 30.
- Background: PubMed 32015507Zhou P, Yang XL, Wang XG, Hu B, Zhang L, Zhang W, Si HR, Zhu Y, Li B, Huang CL, Chen HD, Chen J, Luo Y, Guo H, Jiang RD, Liu MQ, Chen Y, Shen XR, Wang X, Zheng XS, Zhao K, Chen QJ, Deng F, Liu LL, Yan B, Zhan FX, Wang YY, Xiao GF, Shi ZL. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270-273. doi: 10.1038/s41586-020-2012-7. Epub 2020 Feb 3.
- Background: PubMed 15141376Ding Y, He L, Zhang Q, Huang Z, Che X, Hou J, Wang H, Shen H, Qiu L, Li Z, Geng J, Cai J, Han H, Li X, Kang W, Weng D, Liang P, Jiang S. Organ distribution of severe acute respiratory syndrome (SARS) associated coronavirus (SARS-CoV) in SARS patients: implications for pathogenesis and virus transmission pathways. J Pathol. 2004 Jun;203(2):622-30. doi: 10.1002/path.1560.
- Background: PubMed 22496216Kawase M, Shirato K, van der Hoek L, Taguchi F, Matsuyama S. Simultaneous treatment of human bronchial epithelial cells with serine and cysteine protease inhibitors prevents severe acute respiratory syndrome coronavirus entry. J Virol. 2012 Jun;86(12):6537-45. doi: 10.1128/JVI.00094-12. Epub 2012 Apr 11.
- Background: PubMed 25945397Zhang R, Pan Y, Fanelli V, Wu S, Luo AA, Islam D, Han B, Mao P, Ghazarian M, Zeng W, Spieth PM, Wang D, Khang J, Mo H, Liu X, Uhlig S, Liu M, Laffey J, Slutsky AS, Li Y, Zhang H. Mechanical Stress and the Induction of Lung Fibrosis via the Midkine Signaling Pathway. Am J Respir Crit Care Med. 2015 Aug 1;192(3):315-23. doi: 10.1164/rccm.201412-2326OC.
- Individual participant dataSharing planned: No. In discussion phase
Related trials for Pulmonary Alveolar Proteinosis
Active, not recruitingPhase 3
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Autoimmune Pulmonary Alveolar Proteinosis
RecruitingPhase 1/2
Safety and Efficacy of PMT Therapy of hPAP
Hereditary Pulmonary Alveolar Proteinosis
Not yet recruitingPhase 2
A Study of hBMMSC Injection in Patients With aPAP
Autoimmune Pulmonary Alveolar Proteinosis
RecruitingObservational study
A National Registry For Pulmonary Alveolar Proteinosis
Pulmonary Alveolar Proteinosis
RecruitingPhase 3
Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
Autoimmune Pulmonary Alveolar Proteinosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert W Alexander, MD study chair
Global Alliance Regenerative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF), Centricyte 1000 and IV Deployment Of cSVF In Sterile Normal Saline IV Solution in people with Pulmonary Alveolar Proteinosis and COPD, run by Black Tie Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326036, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.