Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

Expanded access No longer available Mesoblast, Ltd.

Summary

The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.

Timeline

Start: —
Primary completion: —
Completion: —

Publications

Results Eckard AR, Borow KM, Mack EH, Burke E, Atz AM. Remestemcel-L Therapy for COVID-19-Associated Multisystem Inflammatory Syndrome in Children. Pediatrics. 2021 May;147(5):e2020046573. doi: 10.1542/peds.2020-046573. Epub 2021 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prochymal®	Cell therapy	2e+06 cells	Intravenous
Background	Diphenhydramine	Unknown	0.5 mg/kg	Intravenous
Background	Diphenhydramine	Unknown	1 mg/kg	Intravenous
Background	Hydrocortisone	Other / unclassified	0.5 mg/kg	Intravenous
Background	Hydrocortisone	Other / unclassified	1 mg/kg	Intravenous

Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

Summary

Timeline

Publications

Drugs

Indications