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.
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.
Biological: Autologous Adipose MSC's
Autologous Adipose Derived Mesenchymal Cells 500,000/kg IV
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
Ryan Welter, MD PhD
(508) 576-8325
r.welter@regenerismedical.com