“…(Santa Maria et al, Santa Maria et al, 2015) The other concern for growth factor treatments for the tympanic membrane is the potential to induce cholesteatoma or malignancy formation, but this is yet to be observed in any animal or human studies of tympanic membrane growth factor treatment. (Acharya et al, 2015, Hakuba et al, 2010, Hakuba et al, 2014, Hakuba et al, 2003, Kanemaru et al, 2011, Ramalho and Bento, 2006, Ma et al, 2002, Dvorak et al, 1995, Santa Maria et al, 2015) Based on all available research to date, the application of trans tympanic HB-EGF is safe to the local tissues. A phase one clinical trial will be needed to definitively answer this question.…”