# Mesoblast

Source: https://onco.cc/companies/mesoblast/  
OnCo record `mesoblast` (Company). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Mesoblast is an Australian cell therapy company whose remestemcel-L became in December 2024 the first mesenchymal stromal cell therapy approved by the FDA, for children with steroid-refractory acute graft-versus-host disease.

## Summary

Mesoblast, headquartered in Melbourne with a US base in New York, develops allogeneic mesenchymal stromal cell therapies from healthy donor bone marrow. After a long regulatory path including an earlier complete response letter, its product remestemcel-L (Ryoncil) was approved by the FDA in December 2024 for steroid-refractory acute graft-versus-host disease in children aged two months and older, a complication of stem cell transplantation for blood cancers. The company is also developing the platform for heart failure and back pain. Company facts are from FDA approval records.

## Fields

- Kind: Company
- Last checked: 2026-09-11
- Also known as: Mesoblast, Inc.; Mesoblast Limited
- Tags: fda-oce-applicant
- HQ: Melbourne
- Type: cell-therapy
- Website: https://www.mesoblast.com

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Mesoblast
- FDA approval announcement for remestemcel-L: https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host

## Connected records

- fronts: [Cell Therapy](https://onco.cc/fronts/cell-therapy/), [Supportive Care & Survivorship](https://onco.cc/fronts/supportive-care/)
- drugs: [Remestemcel-L](https://onco.cc/drugs/remestemcel-l/)
- trials: [MSB-GVHD001](https://onco.cc/trials/msb-gvhd001/)
- key papers: [A phase 3, single-arm, prospective study of remestemcel-L, ex vivo culture-expanded adult human mesenchymal stromal cells for the treatment of pediatric patients who failed to respond to steroid treatment for acute graft-versus-host disease](https://onco.cc/key-papers/paper-msb-gvhd001-bbmt-2020/)

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