Moderate to severe SARS-Cov-2 related acute respiratory distress syndrome MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Mesenchymal Stem Cells (MSCs) from wharton jelly
Product Code: MSC-GW
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: X VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYM
Sponsors
CHRU NANCY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Man or woman 18 years of age or older 2) Patient with a biologically confirmed SARS-CoV-2 infection (by positive RT-PCR on a nasopharyngeal sample or any other sample) 3) Patient with moderate to severe ARDS according to the BERLIN definition defined by a PaO2 / FiO2 ratio =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1) Patient under invasive mechanical ventilation for more than 48 hours 2)Patient with a chronic respiratory disease under oxygen therapy 3) Patients with a history of Class III or IV pulmonary arterial hypertension (WHO classification) 4) Patients under ECMO 5) Immunosuppressive therapy (including corticosteroid therapy> 20 mg prednisolone) 6) Active solid tumor or in remission for less than 2 years, malignant hematological disease, asplenia 7) Patient who has received a hematopoietic stem transplantation or an organ transplant 8) Therapeutic limitations like progression to expected death within 24 hours (according to the opinion of the medical team) 9) Hypersensitivity to albumin or to any of the excipients (caprylic acid or sodium caprylate) 10) Patient included in another ongoing interventional therapeutic trial with medicament 11) Pregnant woman, parturient, nursing mother 12) Minor (not emancipated) 13) Person without liberty by judiciary or administrative decision 14) Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 (hospitalization without consent). 15) Adult over 18 who are under a legal protection measure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate efficacy of WJ-MSCs, compared to a placebo, on respiratory function in patients with SARS-CoV-2 related moderate to severe ARDS.;Secondary Objective: 1) To assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on duration of invasive mechanical ventilation during the hospital stay and maximum for 28 days 2) To assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on the evolution of organ failures during the hospital stay and maximum for 28 days 3) o assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on the duration of stay in intensive care unit, and the mortality during intensive care unit, during hospitalization, on D28 and D90.;Primary end point(s): The respiratory function is evaluated by the PaO2 / FiO2 ratio every day between D0 or D1 (before initiation of treatment with WJ-MSC or placebo) and D14.;Timepoint(s) of evaluation of this end point: D14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The effect of WJ-MSC on respiratory assistance is evaluated by the proportion of days without invasive respiratory assistance during the hospital stay and maximum on D28 (number of days without invasive respiratory assistance / number of hospital days until D28) 2) The evolution of organ failures is measured by the difference in SOFA score between D5-D0 or D1 (depending on the day of initiation of treatment) and D14-D0 or D1, and by the proportion of days without extra-renal treatment and without vasopressor support during the hospital stay and maximum until D28 (number of days without extra-renal treatment / number of days of hospitalization until D28) 3) The duration of stay in intensive care unit and cause of death during the hospital stay, on D28 and D90 4) - Le taux d’Ac anti-HLA mesuré à J0 avant traitement, à J21 et à J90 - La survenue de réactions d’hypersensibilité immédiates (Frissons, hyperthermie associés à une hypotension) dans les 4 à 6 heures suivant l’injection des CSM-GW ou du placebo. - Les risques thrombo-emboliques surveillés cliniquement et biologiquement par la surveillance quotidienne en routine du taux de plaquettes et de l’hémostase (TP, TCA, Fibrinogène, D-dimères), et par la réalisation d’échographies cardiaques transthoraciques quotidiennes durant le séjour en réanimation. - Les risques infectieux, surveillés cliniquement et par la réalisation en routine d’hémocultures si fièvre >38.5°C. - La détection de réaction s’apparentant à une incompatibilité transfusionnelle effectuée par une surveillance attentive pendant la perfusion (notamment de la survenue de réaction cutanée, urticaire ou bronchospasme) avec une prise en charge adaptée immédiate.;Timepoint(s) of evaluation of this end point: 1) maximum until D28 2) D5, D14 and maximum D28 3) D28 and D90 4) during infusion and during hospitalization stay and maximum at D28 | — |
Countries
France
Contacts
Public ContactChef de projet
Direction de la Recherche et de l'Innovation
Outcome results
None listed