Status:
COMPLETED
Clinical Trial 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
Lead Sponsor:
Andalusian Network for Design and Translation of Advanced Therapies
Conditions:
Sars-CoV2
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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
Eligibility Criteria
Inclusion
- Age ≥ 18
- 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
- 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.
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04366323
Start Date
April 27 2020
End Date
December 30 2021
Last Update
April 6 2022
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
2
Hospital Reina Sofía
Córdoba, Spain, 14004
3
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
4
Hospital Universitario Virgen Macarena
Seville, Spain, 41009