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Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respiratory Distress Syndrome

NCT04625738 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-05

No results posted yet for this study

Summary

Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties.

The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10\^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.

Conditions

  • COVID19 ARDS

Interventions

BIOLOGICAL

Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells

Ex vivo expanded Wharton's Jelly derived mesenchymal stem cells will be infused at day 0, day 3 and day 5 (+/- 1 day), in patients with moderate to severe ARDS with a mechanical ventilation. day 0: 1.10\^6 MSC/kg day 3: 0.5. 10\^6 MSC/kg day 5: 0.5 . 10\^6 MSC/kg

BIOLOGICAL

Placebo

Only the vehicle solution, without MSCs, containing albumin 4% , NaCl 0,9% and ACD will be injected to patients at day 0, 3 and 5 (+/-1 day).

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Antoine KIMMOUN, MD, PhD · Central Hospital, Nancy, France

  • Sébastien GIBOT, MD, PhD · Central Hospital, Nancy, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2021-05-14
Completion
2021-09-01

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04625738 on ClinicalTrials.gov