Human retinal pigment epithelial cell therapy

Drug Profile

Human retinal pigment epithelial cell therapy

Alternative Names: ACT hESC-RPE; hESC-derived RPE; hRPE cell therapy; Human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells - Astellas; MA09-hRPE; RPE cell therapy - Astellas

Latest Information Update: 25 Oct 2016

Price : $50

At a glance

  • Originator Advanced Cell Technology
  • Developer Astellas Pharma; CHA Bio & Diostech; Ocata Therapeutics
  • Class Eye disorder therapies; Stem cell 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.

    Yes - Stargardt disease
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No
  • Available For Licensing Yes - Age-related macular degeneration; Stargardt disease

Highest Development Phases

  • Phase II Age-related macular degeneration
  • Phase I/II Stargardt disease
  • Preclinical Degenerative myopia

Most Recent Events

  • 14 Jul 2016 University of California, Los Angeles and Ocata Therapeutics withdraws a phase I/II trial prior to enrolment in Degenerative myopia in USA (NCT02122159)
  • 03 Jun 2016 Astellas Pharma suspends enrolment in a phase-II clinical trials for Age-related macular degeneration in USA (Intraocular) (NCT02563782)
  • 30 Sep 2015 Astellas Pharma completes a phase I/II trials for Age-related macular degeneration and Stargardt's macular dystrophy in United Kingdom (NCT01469832)
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