Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

Phase 1

Recruiting

• Conditions: Coronavirus Infection
• Interventions: Biological: Mesenchymal stromal cells

• Registration Number: NCT04445454
• Lead Sponsor: University of Liege

Brief Summary

The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.

Detailed Description

This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia.

After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease.

The trial will be open for inclusion for 2 years after initiation. Each patient will be followed for 90 days after inclusion. The total study duration will thus be 2 years and 90 days.

Study Timeline

• Study Start: 2020-06-12
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC therapy for severe COVID-19 infection	Mesenchymal stromal cells	After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease.

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia	Day 28	Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)
To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia	Day 28	To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)	Day 90	To assess the number of adverse reactions (ARs), ARs grade \> 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium