The emergence and popularisation of autologous somatic cellular therapies in Australia: therapeutic innovation or regulatory failure?
J Law Med
; 22(1): 65-89, 2014 Sep.
Article
en En
| MEDLINE
| ID: mdl-25341320
ABSTRACT
Private stem cell clinics throughout Australia are providing autologous stem cell therapies for a range of chronic and debilitating illnesses despite the lack of published literature to support the clinical application of these therapies. The Therapeutic Goods Administration has excluded autologous stem cell therapies from its regulatory domain leaving such therapies to be regulated by the same mechanisms that regulate research, such as the National Health and Medical Research Council Research Ethics Guidelines, and clinical practice, such as the Australian Health Practitioner Regulation Agency. However, the provision of these stem cell therapies does not follow the established pathways for legitimate medical advance--therapeutic innovation or research. The current regulatory framework is failing to achieve its aims of protecting vulnerable patients and ensuring the proper conduct of medical practitioners in the private stem cell industry.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Sector Privado
/
Trasplante de Células Madre
/
Regulación Gubernamental
Tipo de estudio:
Guideline
/
Prognostic_studies
Aspecto:
Ethics
Límite:
Humans
País/Región como asunto:
Oceania
Idioma:
En
Revista:
J Law Med
Asunto de la revista:
JURISPRUDENCIA
Año:
2014
Tipo del documento:
Article