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Clinical Trials/EUCTR2020-001364-29-ES
EUCTR2020-001364-29-ES
Active, Not Recruiting
Phase 1

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

Red Andaluza de Diseño y Traslación de Terapias Avanzadas-Fundación Progreso y Salud0 sites26 target enrollmentApril 27, 2020
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DrugsTreatment according to clinical practice by COVID-19

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Red Andaluza de Diseño y Traslación de Terapias Avanzadas-Fundación Progreso y Salud
Enrollment
26
Status
Active, Not Recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 27, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Red Andaluza de Diseño y Traslación de Terapias Avanzadas-Fundación Progreso y Salud

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.
  • •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.

Outcomes

Primary Outcomes

Not specified

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