Trial Profile
Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle
Status:
Active, no longer recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 20 Feb 2024
Price :
$35
*
At a glance
- Drugs Rexlemestrocel-L (Primary)
- Indications Hypoplastic left heart syndrome
- Focus Adverse reactions
- 14 Feb 2024 According to Mesoblast media release, the company plan to meet with FDA to discuss the pathway for approval in often-fatal congenital heart condition.
- 14 Feb 2024 According to Mesoblast media release, the United States Food and Drug Administration (FDA) Granted Mesoblast an Orphan-Drug Designation for Revascor,following submission of results from this randomized controlled trial in children with hypoplastic left heart syndrome (HLHS).
- 18 Jan 2024 According to Mesoblast media release, the United States Food and Drug Administration (FDA) has granted Revascor (rexlemestrocel-L) a Rare Pediatric Disease (RPD) Designation following submission of results from this study.