Autologous stem cell therapy - Shire

Drug Profile

Autologous stem cell therapy - Shire

Alternative Names: Adult stem cell therapy for chronic myocardial ischaemia - Shire; CD34+ autologous stem cell therapy - Shire/Caladarius Biosciences; CD34+ cell therapy - Shire/Caladarius Biosciences

Latest Information Update: 21 Jun 2018

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At a glance

  • Originator Baxter Healthcare Corporation
  • Developer Baxter Healthcare Corporation; Northwestern University; Shire
  • Class Cardiovascular therapies; Stem cell therapies
  • Mechanism of Action Angiogenesis inducing agents; 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 Myocardial ischaemia
  • No development reported Peripheral vascular disorders

Most Recent Events

  • 19 Jun 2018 Autologous stem cell therapy receives regenerative medicine advanced therapy (RMAT) status from the US FDA for Chronic myocardial ischaemia (Refractory angina)
  • 10 May 2018 Caladrius Biosciences reactivated the IND application with the US FDA for CD34 cell therapy programme for the treatment of Chronic myocardial ischaemia
  • 06 Mar 2018 Autologous stem cell therapy licensed to Caladrius Biosciences worldwide
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