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

Regeneris Medical

Status and phase

Not yet enrolling

Phase 1

Conditions

Cyotokine Storm

Covid-19 Pneumonia

Treatments

Biological: Autologous Adipose MSC's

Study type

Interventional

Funder types

Other

Identifiers

NCT04352803

COVID-MSCIV

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.
Pneumonia (uncomplicated):

a. Adults with pneumonia but no signs of severe pneumonia AND NO need for supplemental oxygen
Reported pregnant or positive pregnancy test
Other chronic respiratory disorders such as COPD, emphysema, lung cancer, or cystic fibrosis
BMI lower than 21
Skinfold test < 3 cm at harvest area
Patients with Do-Not-Resuscitate orders that limit mechanical ventilation assistance in place at hospital admission
Males and females < 18 years of age
Patients who are currently breastfeeding
Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection viruses.
History of systemic malignant neoplasms within the last 5 years.
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
Participating in another clinical research study
History of Bleeding disorder which in PI's opinion would render the patient unsuitable for the study
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
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
Platelets count less than 70,0000
History of DVT