NCT05433298

Mesenchymal Stromal Cells for the Treatment of Patients With COVID-19.

Multicenter Phase I/IIa Study of Mesenchymal Stromal Cells for the Treatment of Patients With SARS-CoV-2 Pneumonia.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Paulo Brofman · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is evaluate the feasibility, safety and potential efficacy of an advanced cell therapy product for the treatment of patients with SARS-CoV-2 pneumonia.

Detailed description

Forty patients with COVID-19 will receive an intravenous infusion of one dose of 1.000.000 umbilical cord mesenchymal cells per kilo of the patient. Twenty patients will receive a placebo (Ringer's lactate solution, albumin and heparin). Conventional treatment will be performed together with the infusion of cells, during the study period. The evaluation times will be at pre-infusion, 6 and 24 hours, days 5 and 28, 3 and 6 months. The patient exams performed: serology, biochemistry, blood count and blood gas analysis, metabolomics/proteomics, antibody evaluation, electrocardiogram, CT-scan and X-ray, cytokines, viral load, cytometry, and clinical evaluation. The patients will be evaluated all the time, during hospitalization period, to assess adverse events.

Conditions

• COVID-19 Pneumonia
• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stem cell	Administration of advanced cell product
OTHER	Placebo	Ringer's lactate, albumin and heparin solution

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-11-26
• Completion: 2023-03-31
• First posted: 2022-06-27
• Last updated: 2025-02-10

Locations

1 site across 1 country: Brazil