Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19 : A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19

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..

Medienart:

Klinische Studie

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

ClinicalTrials.gov - (2023) vom: 26. Jan. Zur Gesamtaufnahme - year:2023

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Acute Lung Injury
COVID-19
Phase: Phase 1, Phase 2
Recruitment Status: Completed
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Study Type: Interventional
Syndrome

Anmerkungen:

Source: Link to the current ClinicalTrials.gov record., First posted: May 15, 2020, Last downloaded: ClinicalTrials.gov processed this data on February 01, 2023, Last updated: February 01, 2023

Study ID:

NCT04390139
BST-COVID-01

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG003393178