Regulatory considerations applicable to manufacturing of human placenta-derived mesenchymal stromal cells (MSC) used in clinical trials in Australia and comparison to USA and European regulatory frameworks

Mesenchymal Stem Cell Therapy

Volumn , Issue , 2013, Pages 373-404

  Ilic, Nina ^a   Khalil, Dalia ^b   Hancock, Sonia ^b   Atkinson, Kerry ^a,b,c  

^a MATER HOSPITAL   (Australia)

^b MATER MEDICAL RESEARCH INSTITUTE   (Australia)

^c UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Biologicals framework; Clinical trials; EMA; FDA; Mesenchymal stromal cell; MSC; Placenta; Regulatory requirements; TGA

Indexed keywords

EID: 84903789396     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/978-1-62703-200-1_17     Document Type: Chapter

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