BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

Study Overview
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Brief Summary
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The investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously. The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications.

Official Title
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Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19

Conditions
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COVID, Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes. Over 18 years. Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample. Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection. Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio <200 mm-Hg. Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment. Written or verbal informed consent from the patient, family member or legal representative. Exclusion Criteria: Any other cause of acute respiratory distress not attributable to SARS-Cov-2. RT-PCR of SARS-Cov-2 negative. Multi-organ failure (more than three organs) Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason. Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures. Active tumor disease. Previous immunosuppressive treatment. Allergy or hypersensitivity to the administered products. History of deep vein thrombosis or pulmonary embolism in the last 3 years. Participation in other clinical trials during the 3 months prior to the initial visit.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients receiving regular respiratory distress treatment | |
| Experimental: Treatment<br>Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells | Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells<br>* Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate) |  | 28 days | 
| Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate |  | 6 months |