Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133 (+) Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy

Biomed Res Int

9 November Nov 2015 10 years ago
  • Belotti D, Gaipa G, Bassetti B, Cabiati B, Spaltro G, Biagi E, Parma M, Biondi A, Cavallotti L, Gambini E, Pompilio G
According to the European Medicine Agency (EMA) regulatory frameworks, Advanced Therapy Medicinal Products (ATMP) represent a new category of drugs in which the active ingredient consists of cells, genes, or tissues. In the present work, we report the fully compliant GMP-grade production of ATMP-CD133 which aims to address the treatment of chronic refractory ischemic heart failure.