Overcoming Challenges to Initiating Cell Therapy Clinical Trials in Rapidly Developing Countries: India as a Model | Zendy

Viswanathan Sowmya | Zendy; Rao Mahendra | Zendy; Keating Armand | Zendy; Srivastava Alok | Zendy

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Overcoming Challenges to Initiating Cell Therapy Clinical Trials in Rapidly Developing Countries: India as a Model

Author(s) -

Viswanathan Sowmya,

Rao Mahendra,

Keating Armand,

Srivastava Alok

Publication year - 2013

Publication title -

stem cells translational medicine

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.781

H-Index - 71

eISSN - 2157-6580

pISSN - 2157-6564

DOI - 10.5966/sctm.2013-0019

Subject(s) - pace , clinical trial , translational research , translational medicine , stem cell , biopharmaceutical , medicine , engineering ethics , microbiology and biotechnology , engineering , pathology , biology , genetics , geodesy , geography

Using India as a model system, this study reviews the role of key agencies and processes involved in the field of stem cell‐based clinical research. This study identifies areas that need attention and provides solutions from other established and functioning models in the world to streamline and unify the regulatory and ethics approval processes for cell‐based therapies; it also provides recommendations to check the growth and functioning of clinics offering unproven treatments.

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