Mesenchymal Stem Cell Therapy for SARS-CoV-2-related Acute Respiratory Distress Syndrome

Phase 1

• Conditions: Moderate to severe SARS-Cov-2 related acute respiratory distress syndrome; MedDRA version: 23.0Level: PTClassification code 10084268Term: COVID-19System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-002772-12-FR
• Lead Sponsor: CHRU NANCY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-03
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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 <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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified