Acute respiratory distress syndrome MedDRA version: 21.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: XCEL-UMC-BETA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: EX VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS
Current Sponsor code: XCEL-UMC-BETA
Other de
Sponsors
Banc de Sang i Teixits
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: All-cause mortality at day 28;Secondary Objective: 1-To assess the safety and feasibility of WJ-MSC administration compared to placebo in the treatment of patients with SARS-CoV-2 infection and ARDS 2-Need for treatment with rescue medication 3-Need and duration of mechanical ventilation 4-Ventilator free days 5-Evolution of PaO2 / FiO2 ratio at 3, 5, 7, 14, 21 and 28 days after starting treatment 6-Evolution of the SOFA index at 3, 5, 7, 14, 21 and 28 days after starting treatment 7-Evolution of the APACHE II score at 3, 5, 7, 14, 21 and 28 days after starting treatment 8-Duration of hospitalization 9-Evolution of disease biomarkers: RT-PCR, LDH, D-dimer and Ferritin at 3, 5, 7, 14, 21 y 28 after starting treatment 10-Evolution of markers of immune response (leucocyte count, neutrophils) at 3, 5, 7, 14, 21 y 28 days after starting treatment;Primary end point(s): Number of patients who died on day +28, by treatment group;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Safety and feasibility. Safety will be assessed by physical examination, vital signs, laboratory data, and adverse events throughout the study, by treatment group. Feasibility will be evaluated by the time elapsed from the request of the treatment by the hospital center until the delivery date and the number of patients that can be treated within 2 days of the request for treatment. 2- Number and percentage of patients who, after the start of treatment, required rescue medication at day +28 3- Number of days that the patient requires invasive mechanical ventilation from the start of treatment to day +28 4- Days after treatment in which the patient remains alive and free of invasive mechanical ventilation, up to day +28 5- Variation of the oxygenation index (PaO2 / FiO2) 6- Variation of the score of the SOFA Index 7- Variation of APACHE II score 8- Days of stay in the ICU from the day of admission until discharge to day 28, or date of death if earlier, by treatment group. 9- Variation in the values of the markers of evolution of the disease (RT-PCR, LDH, D-dimer and Ferritin) 10- Variation in the count and percentage of leukocytes and neutrophils;Timepoint(s) of evaluation of this end point: At day 3, 5, 7, 14, 21 and 28 after starting treatment with respect to the baseline value, by treatment group | — |
Countries
Spain
Contacts
Public ContactBanc de Sang i Teixits
Banc de Sang i Teixits
Outcome results
None listed