Efficacy of infusions of mesenchymal stem cells from Wharton jelly in the moderate to severe SARS-Cov-2 related acute respiratory distress syndrome (COVID-19):A Phase IIa double-blind randomized controlled trial - MSC-COVID19

CHRU NANCY0 个研究点目标入组 30 人开始时间: 2020年6月3日最近更新: 2021年11月29日

适应症

试验速览

暂无简介。

•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 <200 and with endotracheal intubation and under invasive mechanical ventilation
•4) Patient hospitalized in the intensive care unit
•5) Provision of a written informed consent to participate to the study or for whom the consent of a family member or support person has been obtained (if the patient is unable to give consent) or inclusion in an immediate vital emergency if applicable
•6) Any woman of childbearing age with a negative Beta HCG test
•7) Personne affiliée à un régime de Sécurité Sociale ou bénéficiaire d’un tel régime
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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

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