Status:
NOT_YET_RECRUITING
Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease
Lead Sponsor:
Regeneris Medical
Conditions:
Covid-19 Pneumonia
Cyotokine Storm
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
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 fu...
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 morta...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years of and less than 90
- COVID 19 diagnosis confirmed
- Ability to give informed consent
- Hospitalized
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04352803
Start Date
April 1 2020
End Date
April 1 2026
Last Update
April 21 2020
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