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

April 17, 2020 updated by: Regeneris Medical

IV Infusion of Autologous Adipose Derived Mesenchymal Cells for Abatement of Respiratory Compromise in SARS-CoV-2 Pandemic (COVID-19)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • 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 Contact

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:

  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

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 28 days
Efficacy - Frequency of progression to mechanical ventilation
Time Frame: up to 28 days
Changes in progression or rate of subjects progressing to mechanical ventilation
up to 28 days
Efficacy - Changes in length of mechanical ventilation
Time Frame: up to 28 days
Changes in time subjects remain on mechanical ventilation
up to 28 days
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
up to 28 days
Efficacy - Changes in length of hospital stay
Time Frame: up to 28 days
Length of Hospital Stay
up to 28 days
Efficacy - Changes in mortality rate
Time Frame: up to 28 days
Mortality rate from all causes
up to 28 days

Collaborators and Investigators

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

Sponsor

Regeneris Medical

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 (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-MSCIV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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