Phase I / II Clinical Trial, Multicenter, Randomized and Controlled, to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19

Andalusian Network for Design and Translation of Advanced Therapies6 sites in 1 country26 target enrollmentApril 27, 2020

ConditionsSars-CoV2

InterventionsALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

DrugsALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

Overview

Phase: Phase 1
Intervention: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Conditions: Sars-CoV2
Sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Enrollment: 26
Locations: 6
Primary Endpoint: Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Phase I/II clinical trial to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia

Registry

clinicaltrials.gov

Start Date

April 27, 2020

End Date

December 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection
•Life expectancy \> 48 hours.
•Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial.

Exclusion Criteria

•Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C).
•History of multiple allergies, including allergy to Penicillin or other Blactams.
•Pregnant and lactating women.
•Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe.
•Patients with autoimmune diseases.
•Chronic heart failure with ejection fraction less than 30%.
•Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.