Official Title
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
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

Completed
SARS-COV2

Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

Two doses of 80 million adipose-tissue derived mesenchymal stem cells

Eligibility Criteria

Inclusion Criteria:

1. Age ≥ 18

2. Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection

3. Life expectancy > 48 hours.

4. Commitment to use a contraceptive method of proven efficacy in both men and women
during the duration of the clinical trial.

Exclusion Criteria:

1. Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus,
adenovirus or other respiratory infections, active infection by HBV or C).

2. History of multiple allergies, including allergy to Penicillin or other Blactams.

3. Pregnant and lactating women.

4. Patients with malignant tumors or hemopathies or any state of immunosuppression
considered as severe.

5. Patients with autoimmune diseases.

6. Chronic heart failure with ejection fraction less than 30%.

7. Any other condition for which, in the opinion of the main investigator, the subject is
considered not to be in compliance with the study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Spain
Locations

Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain

Hospital Reina Sofía
Córdoba, Spain

Hospital Universitario Virgen de las Nieves
Granada, Spain

Hospital Universitario Virgen Macarena
Sevilla, Spain

Hospital Unversitario Virgen del Rocío
Sevilla, Spain

Hospital Nuestra Señora de Valme
Sevilla, Spain

Andalusian Network for Design and Translation of Advanced Therapies
NCT Number
MeSH Terms
Pneumonia