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Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04352803
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : April 21, 2020
Information provided by (Responsible Party):
Regeneris Medical

Brief Summary:

The aim of this study is to evaluate the safety and efficacy of autologous adipose-derived mesenchymal cells for treating confirmed or suspected patients with SARS-CoV-2 and compromised respiratory function requiring hospitalization.

The hypothesis of the Study is autologous adipose-derived mesenchymal cells given IV to eligible patients will improve clinical outcomes of COVID 19 positive patients with severe pneumonia or ARDS by reducing or avoiding cytokine storm.

Condition or disease Intervention/treatment Phase
Covid-19 Pneumonia Cyotokine Storm Biological: Autologous Adipose MSC's Phase 1

Detailed Description:

While most patients with SARS-CoV-2 present with mild respiratory disease with the most common symptoms of fever and cough, approximately 14 % progress to severe pneumonia and ARDS.

The overall mortality rate is 2% but varies by country and age of the patient.

In COVID-19 ARDS standard supportive care and treatment for underlying illnesses remain the mainstay with limited success.

Numerous antiviral medications including remdesivir, lopinavir-ritonavir or lopinavir-ritonavir and interferon Beta-1a are in clinical trials but safety and efficacy remain unclear.

Inflammation associated with a cytokine storm begins at a local site and spreads throughout the body via systemic circulation. The lungs and other organs are damaged with progressive inflammation.

Mesenchymal cells offer the potential to treat viral infection both directly and through reducing the immune response. MSCs play a role as an immunomodulator, which is safe and effective as demonstrated in numerous clinical trials.

Mesenchymal cells are a potential privileged cell-based therapy in SARS-CoV-2. MSCs derived extracellular vesicles have demonstrated comparable and sometimes more effective effects in ameliorating lung inflammation and injury.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is an Interventional, Prospective, Open label (Voluntary Assignment), single to multiple center expansion, unmatched controlled, Sequentially Interim analysis tested Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IV Infusion of Autologous Adipose Derived Mesenchymal Cells for Abatement of Respiratory Compromise in SARS-CoV-2 Pandemic (COVID-19)
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Autologous Adipose Derived Mesenchymal Cells
Conventional treatment plus MSC's IV
Biological: Autologous Adipose MSC's
Autologous Adipose Derived Mesenchymal Cells 500,000/kg IV

No Intervention: Untreated
Conventional treatment only

Primary Outcome Measures :
  1. Safety - Incidence of unexpected adverse events [ Time Frame: up to 28 days ]
    Incidence of unexpected adverse events within 28 days following IV administration of MSCs.

  2. Efficacy - Frequency of progression to mechanical ventilation [ Time Frame: up to 28 days ]
    Changes in progression or rate of subjects progressing to mechanical ventilation

  3. Efficacy - Changes in length of mechanical ventilation [ Time Frame: up to 28 days ]
    Changes in time subjects remain on mechanical ventilation

  4. Efficacy - Changes in length of weaning of mechanical ventilation [ Time Frame: up to 28 days ]
    Changes in length of time subjects wean off of mechanical ventilation

  5. Efficacy - Changes in length of hospital stay [ Time Frame: up to 28 days ]
    Length of Hospital Stay

  6. Efficacy - Changes in mortality rate [ Time Frame: up to 28 days ]
    Mortality rate from all causes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  1. Male or female patients ≥ 18 years of and less than 90
  2. COVID 19 diagnosis confirmed
  3. Ability to give informed consent
  4. Hospitalized

Exclusion Criteria:

  1. Mild Illness

    1. Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, or headache. Rarely, patients may also present with diarrhea, nausea and vomiting.
    2. The elderly and immunosuppressed candidates may present with atypical symptoms. Symptoms due to physiologic adaptations of pregnancy or adverse pregnancy events, such as e.g. dyspnea, fever, GI-symptoms or fatigue, may overlap with COVID-19 symptoms. Still, they will be excluded, unless they progress to Inclusion Criteria within 72 hours from recruitment.
  2. Pneumonia (uncomplicated):

    a. Adults with pneumonia but no signs of severe pneumonia AND NO need for supplemental oxygen

  3. Reported pregnant or positive pregnancy test
  4. Other chronic respiratory disorders such as COPD, emphysema, lung cancer, or cystic fibrosis
  5. BMI lower than 21
  6. Skinfold test < 3 cm at harvest area
  7. Patients with Do-Not-Resuscitate orders that limit mechanical ventilation assistance in place at hospital admission
  8. Males and females < 18 years of age
  9. Patients who are currently breastfeeding
  10. Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection viruses.
  11. History of systemic malignant neoplasms within the last 5 years.
  12. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
  13. Participating in another clinical research study
  14. History of Bleeding disorder which in PI's opinion would render the patient unsuitable for the study
  15. PT (plasma) < 9 or >11.6 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
  16. PTT < 23 or >32 seconds and in the opinion of the PI and attending physician that lipoaspiration would be contraindicated. May be eligible for re-screening if coagulopathy improves within 72 hours of consent
  17. Platelets count less than 70,0000
  18. History of DVT

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 identifier (NCT number): NCT04352803

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Contact: Ryan Welter, MD PhD (508) 576-8325

Sponsors and Collaborators
Regeneris Medical

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Responsible Party: Regeneris Medical Identifier: NCT04352803    
Other Study ID Numbers: COVID-MSCIV
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneris Medical:
Additional relevant MeSH terms:
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Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases