Efficacy and safety evaluation of umbilical cord mesenchymal stem cells for the treatment of patients with respiratory failure due to coronavirus (COVID-19)
- Conditions
- Acute respiratory distress syndromeMedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001505-22-ES
- Lead Sponsor
- Banc de Sang i Teixits
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
1.Participation in the prospective observational epidemiological study CIBERESUCICOVID (PCR for SARS-CoV-2 positive, ICU admission)
2.Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 = 200 mmHg)
3.Male or female, aged 18 to 70 years old
4.Signed informed consent by the patient or by a legal representative
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Expected survival less than 3 days
2.Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
3.Neoplastic disease either active or without complete remission
4.Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
5.Pregnant or lactating women
6.Participation in another clinical trial with an experimental drug in the last 30 days
7.Other pathologies that, in medical judgment, contraindicate participation in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method