Trial Profile
Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Status:
Completed
Phase of Trial:
Clinical Phase Unknown
Latest Information Update: 04 Oct 2022
Price :
$35
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At a glance
- Drugs Remestemcel-L (Primary)
- Indications Graft-versus-host disease
- Focus Expanded access; Registrational; Therapeutic Use
- Sponsors Mesoblast
- 02 Oct 2022 According to a Mesoblast media release, the company has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA.
- 30 Aug 2022 According to a Mesoblast media release,BLA resubmission to FDA expected by the end of Q3 CY2022.
- 28 Apr 2022 According to a Mesoblast media release, if the BLA resubmission is accepted, CBER will consider the adequacy of the clinical data in the context of the related CMC issues.