Status:
COMPLETED
Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19
Lead Sponsor:
Banc de Sang i Teixits
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg pe...
Detailed Description
This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal cells (WJ-MSC...
Eligibility Criteria
Inclusion
- Positive PCR fpr SARS-CoV-2
- Intensive Care Unit admission for less than 3 days
- Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg \< PaO2/FiO2 ≤ 200 mmHg)
- Male or female, aged 18 to 70 years old
- Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)
Exclusion
- Expected survival less than 3 days
- Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
- Neoplastic disease either active or without complete remission
- Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
- Pregnant or lactating women
- Participation in another clinical trial with an experimental drug in the last 30 days
- Other pathologies that, in medical judgment, contraindicate participation in the study
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04390139
Start Date
May 13 2020
End Date
December 20 2022
Last Update
January 26 2023
Active Locations (5)
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1
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Mútua de Terrassa
Terrassa, Barcelona, Spain, 08221
3
Hospital del Mar
Barcelona, Spain, 08003
4
Hospital Vall d'Hebron
Barcelona, Spain, 08035