Study with stem cells from allogenic adipose tissue, in patients with coronavirus severe pneumonia

Phase 1

• Conditions: Severe COVID-19 pneumonia; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - Investigations; MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001364-29-ES
• Lead Sponsor: Red Andaluza de Diseño y Traslación de Terapias Avanzadas-Fundación Progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-27
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

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 B-lactams.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified