Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
Annual rept. 30 Sep 2012-29 Sep 2013
OHIO STATE UNIV COLUMBUS
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Tympanic membrane perforation TMP is the most common primary blast injury in the current conflicts in Afghanistan and Iraq occurring in 10-35 of service members wounded by combat explosions. The hypothesis to be tested in this Phase I open label dose-finding study is that topical application of fibroblast growth factor-1 to the TMP will result in closure of chronic TM perforations. Primary aims are 1 to evaluate the safety and tolerability of FGF-1 to treat chronic non-healing tympanic membrane perforations 2 to determine the maximum tolerated- or optimal biologic-dose of FGF-1 required to achieve complete closure of chronic non-healing tympanic membrane perforations 3 to determine efficacy of TMP closure at the optimal biologic dose in a placebo controlled blinded phase II study. To date, an investigational new drug IND number has been assigned by the FDA for use of FGF-1 in this indication. Institutional review board approval is currently being sought at the local level. Once approved at the local level, the protocol will be submitted to the USAMRMC s Office of Research Protections for review and approval. If successful, this study will change the paradigm for treatment of tympanic membrane perforations in military and civilian populations alike. Both will have complete recovery of TM function with middle ear protection without surgical intervention and reduction of recovery time. The transition of this application may lead to adding of inner ear protectants to help recover associated sensorineural hearing loss attendant with blast injuries.
- Anatomy and Physiology
- Medicine and Medical Research