NCT04445454

Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stromal cells	Bone marrow collection and MSC expansion cultures will be carried out at the Laboratory of Cell and Gene Therapy (LTCG) at the University of Liège as described in IMPD and its SOPs.

Timeline

• Start date: 2020-06-12
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2020-06-24
• Last updated: 2024-05-09

Locations

1 site across 1 country: Belgium