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The absence of approval means there is no licensed manufacturer, no quality standards enforced by health authorities, and no legal framework for medical use

doi:10.1111/j.1600-079X.2007.00499.x McGlashan EM, Nandam LS, Vidafar P,Mansfield DR, Rajaratnam SMW, Cain SW

Safety, tolerability, and pharmacodynamics of intrathecal injection of recombinant human HGF (KP-100) in subjects with amyotrophic lateral sclerosis: a Phase I trial