NCT04348461

BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously. The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications.

Conditions

• COVID
• Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells	Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg

Timeline

• Start date: 2020-05-06
• Primary completion: 2020-09-15
• Completion: 2021-09-30
• First posted: 2020-04-16
• Last updated: 2021-03-17

Locations

1 site across 1 country: Spain