Trial Profile
A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Culture-Expanded Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 29 Mar 2024
Price :
$35
*
At a glance
- Drugs Remestemcel-L (Primary)
- Indications Graft-versus-host disease
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Mesoblast
- 25 Mar 2024 According to a Mesoblast media release, company announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
- 30 Jan 2024 According to a Mesoblast media release, new potency assay data shows that the RYONCIL product made with the current manufacturing process has undergone successful inspection by FDA.This could provide support for approval of the pediatric indication given the absence of any approved therapies for children.
- 30 Jan 2024 According to a Mesoblast media release, company has requested a meeting with FDA this quarter to provide additional potency and characterization data for its product RYONCIL which it believes demonstrate that the product used as second-line after corticosteroids in the pivotal Phase 3 trial GVHD001 in children with SR-aGVHD.