Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19
- Conditions
- COVID-19SARS-CoV 2Adult Respiratory Distress Syndrome
- Interventions
- Other: Placebo
- Registration Number
- NCT04390139
- Lead Sponsor
- Banc de Sang i Teixits
- 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 per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.
- 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) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. Patients will then be randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3. Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up.
The study treatments (A or B) will be added on top of the Standard of Care treatment prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous administration of 1E6cells/Kg.
Recruitment will be competitive for the centers participating in the study. A Data Safety and Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment A XCEL-UMC-BETA Wharton-Jelly mesenchymal stromal cells on D1 and D3 Treatment B Placebo Placebo on D1 and D3
- Primary Outcome Measures
Name Time Method All-cause mortality at day 28 Day 28 Number of patients who died, by treatment group
- Secondary Outcome Measures
Name Time Method Safety of WJ-MSC Day 28 Number of patients with treatment-emergent adverse events, by treatment group
Need for treatment with rescue medication Day 28 Number of patients who, after the start of treatment, required rescue medication, by treatment group
Need and duration of mechanical ventilation Day 28 Number of days that the patient requires invasive mechanical ventilation from the start of treatment to day +28, by treatment group
Ventilator free days Day 28 Days after treatment in which the patient remains alive and free of invasive mechanical ventilation, per treatment group.
Evolution of PaO2 / FiO2 ratio Day 28 Variation of the oxygenation index (PaO2 / FiO2) with respect to the baseline value, by treatment group.
Evolution of the SOFA index Day 28 Variation of the score of the Sequential Organ Failure Assessment (SOFA) Index with respect to the baseline value, by treatment group.
Evolution of the APACHE II score Day 28 Variation of Acute Physiology and Chronic Health disease Classification System II (APACHE II) score, by treatment group.
Duration of hospitalization Day 28 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.
Evolution of markers of immune response (leucocyte count, neutrophils) Day 28 Variation in the count and percentage of leukocytes and neutrophils, by treatment group.
Feasibility of WJ-MSC administration Day 28 Feasibility will be evaluated by the number of patients treated within 2 days of the request for treatment.
Evolution of disease biomarker: polymerase chain reaction (RT-PCR) Day 28 Variation in the values of the biomarker, by treatment group.
Evolution of disease biomarker: lactate dehydrogenase (LDH) Day 28 Variation in the values of the biomarker, by treatment group.
Evolution of disease biomarker: D-dimer Day 28 Variation in the values of the biomarker, by treatment group.
Evolution of disease biomarker: Ferritin Day 28 Variation in the values of the biomarker, by treatment group.
Trial Locations
- Locations (5)
Mútua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain