Session Type: ePosters
Session Title: ePosters
Authors(s): M.E. Martínez-Muñoz (1), C. Payares (1), I. Lipperheide (1), R. Malo De Molina (1), I. Salcedo (1, 2), R. Alonso (2), T. Martín-Donaire (2), R. Sánchez (2), R. Zafra (2), M. García Berciano (1), A. Trisán Alonso (1), M. Pérez Torres (1), A. Ramos (1), P. Ussetti (1), J.J. Rubio (1), C. Avendaño-Solà (1, 2), R.F. Duarte (1, 2)
Authors Affiliations(s): (1) Hospital Universitario Puerta de Hierro Majadahonda, Spain, (2) Instituto de Investigación Sanitaria Puerta de Hierro-Segovia Arana, Spain
Background:
Acute respiratory distress syndrome (ARDS) induced by SARS-CoV-2 leads to respiratory failure and high mortality rates, with no specific treatment beyond supportive care and mechanical ventilation. Mesenchymal stromal cells (MSC) have immunomodulatory and tissue-regenerative properties and have shown promising results in ARDS of multiple causes, including preliminary evidence in COVID-19.
Methods:We conducted a single-center, randomized, placebo-controlled, double-blind clinical trial, to assess the efficacy and safety of allogeneic bone marrow-derived MSC infusion in patients with COVID-19-induced moderate to severe ARDS (EudraCT: 2020-002193-27). In addition to standard of care, patients were randomized 1:1 to receive either an intravenous dose of approximately 1x106 MSC/kg or an equivalent volume of the same saline-based solution without MSC. The primary efficacy endpoint was the change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration. Key secondary efficacy and safety endpoints included clinical improvement in the WHO 7-point ordinal scale in the first 28 days after treatment and the cumulative incidence of infusion and treatment-related adverse events.
Results:From October 1st to December 4th, 2020, 21 patients were screened and 20 were randomized. Baseline characteristics are shown in table 1. Improvement of at least one category of the WHO 7-point ordinal scale at day 7 was greater in the MSC arm (5 patients, 50%) than in the control arm (0 patients, 0%; p=0.033). The increase in PaO2/FiO2 at day 7 from baseline was 83.3 in the MSC group vs 57.6 in the control group (p=0.318). In addition, time to discontinuation of supplemental oxygen therapy (WHO ≤3) was significantly shorter for the experimental arm (15.0 vs 22.6 days; p=0.013). No differences were detected in other secondary endpoints (table 2). One patient in the control group died at day 51, due to abdominal sepsis. No infusion-related adverse events or treatment-related serious adverse events occurred.
Conclusions:Our data confirms the safety of MSC administration and suggests it may be beneficial in COVID-19 patients with ARDS and an otherwise dismal prognosis. Larger trials to enhance efficacy assessment of this therapy are warranted.
Keyword(s): COVID-19, Mesenchymal Stromal Cells, Acute Respiratory Distress SyndromeCOI Other: This study was partly funded by the "Transferencia Nominativa COVID-19" of the Consejería de Sanidad de la Comunidad de Madrid and the "Proyecto Mascarillas Boticaria".
Session Type: ePosters
Session Title: ePosters
Authors(s): M.E. Martínez-Muñoz (1), C. Payares (1), I. Lipperheide (1), R. Malo De Molina (1), I. Salcedo (1, 2), R. Alonso (2), T. Martín-Donaire (2), R. Sánchez (2), R. Zafra (2), M. García Berciano (1), A. Trisán Alonso (1), M. Pérez Torres (1), A. Ramos (1), P. Ussetti (1), J.J. Rubio (1), C. Avendaño-Solà (1, 2), R.F. Duarte (1, 2)
Authors Affiliations(s): (1) Hospital Universitario Puerta de Hierro Majadahonda, Spain, (2) Instituto de Investigación Sanitaria Puerta de Hierro-Segovia Arana, Spain
Background:
Acute respiratory distress syndrome (ARDS) induced by SARS-CoV-2 leads to respiratory failure and high mortality rates, with no specific treatment beyond supportive care and mechanical ventilation. Mesenchymal stromal cells (MSC) have immunomodulatory and tissue-regenerative properties and have shown promising results in ARDS of multiple causes, including preliminary evidence in COVID-19.
Methods:We conducted a single-center, randomized, placebo-controlled, double-blind clinical trial, to assess the efficacy and safety of allogeneic bone marrow-derived MSC infusion in patients with COVID-19-induced moderate to severe ARDS (EudraCT: 2020-002193-27). In addition to standard of care, patients were randomized 1:1 to receive either an intravenous dose of approximately 1x106 MSC/kg or an equivalent volume of the same saline-based solution without MSC. The primary efficacy endpoint was the change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration. Key secondary efficacy and safety endpoints included clinical improvement in the WHO 7-point ordinal scale in the first 28 days after treatment and the cumulative incidence of infusion and treatment-related adverse events.
Results:From October 1st to December 4th, 2020, 21 patients were screened and 20 were randomized. Baseline characteristics are shown in table 1. Improvement of at least one category of the WHO 7-point ordinal scale at day 7 was greater in the MSC arm (5 patients, 50%) than in the control arm (0 patients, 0%; p=0.033). The increase in PaO2/FiO2 at day 7 from baseline was 83.3 in the MSC group vs 57.6 in the control group (p=0.318). In addition, time to discontinuation of supplemental oxygen therapy (WHO ≤3) was significantly shorter for the experimental arm (15.0 vs 22.6 days; p=0.013). No differences were detected in other secondary endpoints (table 2). One patient in the control group died at day 51, due to abdominal sepsis. No infusion-related adverse events or treatment-related serious adverse events occurred.
Conclusions:Our data confirms the safety of MSC administration and suggests it may be beneficial in COVID-19 patients with ARDS and an otherwise dismal prognosis. Larger trials to enhance efficacy assessment of this therapy are warranted.
Keyword(s): COVID-19, Mesenchymal Stromal Cells, Acute Respiratory Distress SyndromeCOI Other: This study was partly funded by the "Transferencia Nominativa COVID-19" of the Consejería de Sanidad de la Comunidad de Madrid and the "Proyecto Mascarillas Boticaria".
Session Type: ePosters
Session Title: ePosters
Authors(s): M.E. Martínez-Muñoz (1), C. Payares (1), I. Lipperheide (1), R. Malo De Molina (1), I. Salcedo (1, 2), R. Alonso (2), T. Martín-Donaire (2), R. Sánchez (2), R. Zafra (2), M. García Berciano (1), A. Trisán Alonso (1), M. Pérez Torres (1), A. Ramos (1), P. Ussetti (1), J.J. Rubio (1), C. Avendaño-Solà (1, 2), R.F. Duarte (1, 2)
Authors Affiliations(s): (1) Hospital Universitario Puerta de Hierro Majadahonda, Spain, (2) Instituto de Investigación Sanitaria Puerta de Hierro-Segovia Arana, Spain
Background:
Acute respiratory distress syndrome (ARDS) induced by SARS-CoV-2 leads to respiratory failure and high mortality rates, with no specific treatment beyond supportive care and mechanical ventilation. Mesenchymal stromal cells (MSC) have immunomodulatory and tissue-regenerative properties and have shown promising results in ARDS of multiple causes, including preliminary evidence in COVID-19.
Methods:We conducted a single-center, randomized, placebo-controlled, double-blind clinical trial, to assess the efficacy and safety of allogeneic bone marrow-derived MSC infusion in patients with COVID-19-induced moderate to severe ARDS (EudraCT: 2020-002193-27). In addition to standard of care, patients were randomized 1:1 to receive either an intravenous dose of approximately 1x106 MSC/kg or an equivalent volume of the same saline-based solution without MSC. The primary efficacy endpoint was the change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration. Key secondary efficacy and safety endpoints included clinical improvement in the WHO 7-point ordinal scale in the first 28 days after treatment and the cumulative incidence of infusion and treatment-related adverse events.
Results:From October 1st to December 4th, 2020, 21 patients were screened and 20 were randomized. Baseline characteristics are shown in table 1. Improvement of at least one category of the WHO 7-point ordinal scale at day 7 was greater in the MSC arm (5 patients, 50%) than in the control arm (0 patients, 0%; p=0.033). The increase in PaO2/FiO2 at day 7 from baseline was 83.3 in the MSC group vs 57.6 in the control group (p=0.318). In addition, time to discontinuation of supplemental oxygen therapy (WHO ≤3) was significantly shorter for the experimental arm (15.0 vs 22.6 days; p=0.013). No differences were detected in other secondary endpoints (table 2). One patient in the control group died at day 51, due to abdominal sepsis. No infusion-related adverse events or treatment-related serious adverse events occurred.
Conclusions:Our data confirms the safety of MSC administration and suggests it may be beneficial in COVID-19 patients with ARDS and an otherwise dismal prognosis. Larger trials to enhance efficacy assessment of this therapy are warranted.
Keyword(s): COVID-19, Mesenchymal Stromal Cells, Acute Respiratory Distress SyndromeCOI Other: This study was partly funded by the "Transferencia Nominativa COVID-19" of the Consejería de Sanidad de la Comunidad de Madrid and the "Proyecto Mascarillas Boticaria".
Session Type: ePosters
Session Title: ePosters
Authors(s): M.E. Martínez-Muñoz (1), C. Payares (1), I. Lipperheide (1), R. Malo De Molina (1), I. Salcedo (1, 2), R. Alonso (2), T. Martín-Donaire (2), R. Sánchez (2), R. Zafra (2), M. García Berciano (1), A. Trisán Alonso (1), M. Pérez Torres (1), A. Ramos (1), P. Ussetti (1), J.J. Rubio (1), C. Avendaño-Solà (1, 2), R.F. Duarte (1, 2)
Authors Affiliations(s): (1) Hospital Universitario Puerta de Hierro Majadahonda, Spain, (2) Instituto de Investigación Sanitaria Puerta de Hierro-Segovia Arana, Spain
Background:
Acute respiratory distress syndrome (ARDS) induced by SARS-CoV-2 leads to respiratory failure and high mortality rates, with no specific treatment beyond supportive care and mechanical ventilation. Mesenchymal stromal cells (MSC) have immunomodulatory and tissue-regenerative properties and have shown promising results in ARDS of multiple causes, including preliminary evidence in COVID-19.
Methods:We conducted a single-center, randomized, placebo-controlled, double-blind clinical trial, to assess the efficacy and safety of allogeneic bone marrow-derived MSC infusion in patients with COVID-19-induced moderate to severe ARDS (EudraCT: 2020-002193-27). In addition to standard of care, patients were randomized 1:1 to receive either an intravenous dose of approximately 1x106 MSC/kg or an equivalent volume of the same saline-based solution without MSC. The primary efficacy endpoint was the change in the PaO2/FiO2 ratio from baseline to day 7 of treatment administration. Key secondary efficacy and safety endpoints included clinical improvement in the WHO 7-point ordinal scale in the first 28 days after treatment and the cumulative incidence of infusion and treatment-related adverse events.
Results:From October 1st to December 4th, 2020, 21 patients were screened and 20 were randomized. Baseline characteristics are shown in table 1. Improvement of at least one category of the WHO 7-point ordinal scale at day 7 was greater in the MSC arm (5 patients, 50%) than in the control arm (0 patients, 0%; p=0.033). The increase in PaO2/FiO2 at day 7 from baseline was 83.3 in the MSC group vs 57.6 in the control group (p=0.318). In addition, time to discontinuation of supplemental oxygen therapy (WHO ≤3) was significantly shorter for the experimental arm (15.0 vs 22.6 days; p=0.013). No differences were detected in other secondary endpoints (table 2). One patient in the control group died at day 51, due to abdominal sepsis. No infusion-related adverse events or treatment-related serious adverse events occurred.
Conclusions:Our data confirms the safety of MSC administration and suggests it may be beneficial in COVID-19 patients with ARDS and an otherwise dismal prognosis. Larger trials to enhance efficacy assessment of this therapy are warranted.
Keyword(s): COVID-19, Mesenchymal Stromal Cells, Acute Respiratory Distress SyndromeCOI Other: This study was partly funded by the "Transferencia Nominativa COVID-19" of the Consejería de Sanidad de la Comunidad de Madrid and the "Proyecto Mascarillas Boticaria".