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

Regeneris Medical0 sites20 target enrollmentApril 2020

ConditionsCovid-19 Pneumonia Cyotokine Storm

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Covid-19 Pneumonia
Sponsor: Regeneris Medical
Enrollment: 20
Primary Endpoint: Efficacy - Changes in length of mechanical ventilation
Status: Not yet recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

April 2020

End Date

April 2026

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Regeneris Medical

Responsible Party

Sponsor

Eligibility Criteria

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
•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.
•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