Autologous mucosal epithelial cells (OraNera) - CellSeed

Drug Profile

Autologous mucosal epithelial cells (OraNera) - CellSeed

Alternative Names: CAOMECS; CLS 2702C; Cultured autologous oral mucosal epithelial cell sheet (Caomecs) - CellSeed; Epithelial cell sheet for corneal regeneration (OraNera) - CellSeed; OraNera

Latest Information Update: 07 Sep 2016

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At a glance

  • Originator CellSeed
  • Class Cell therapies; Eye disorder therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III Inflammation
  • Preregistration Submission Withdrawal Limbal stem cell deficiency

Most Recent Events

  • 01 Jun 2016 Phase-III clinical trials in Inflammation in Japan (unspecified route) (NCT02866019)
  • 01 Mar 2015 CellSeed terminates a phase III trial for Limbal stem cell deficiency in Germany prior to enrolment initiation (NCT01489501)
  • 14 Mar 2013 Regulatory submission withdrawn for Limbal stem cell deficiency (in adults) in European Union (Ophthalmic)
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