A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial. - A Phase III study on the regenerative treatment of tympanic membrane with NPC-18 and FBG-18-multicenter,investigator initiated clinical trial.

Overview

No summary available.

Registry

who.int

Start Date

June 1, 2015

End Date

February 4, 2016

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\) TMP caused by burn or radiation therapy 2\) In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry 3\) Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity 4\) No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge 5\) History of tympanoplasty 6\) A Part of the eardrum adhered to tympanic cavity 7\) By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration) 8\) Abnormality in the chain and ear ossicles 9\) Air\-bone gap difference more than 25dB by patch hearing test 10\) Unable to see whole edge of TMP due to narrow external auditory canal 11\) Unable to wash out Ear drops during the treatment period 12\) Presenting with uncontrolled diabetes (NGSP HbA1c 6\.9% and more) 13\) Presenting with autoimmune disease 14\) History of malignancy within 3 years prior to obtained informed concent 15\) Administration of immunosuppressive agent or anti\-cancer\-agent 16\) History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others 17\) Though out the period from screening to treatment, patient who is unable to wash out "Thrombolytic agent", "Anticoagulant", "Anti\-platelet agent", "Procoagulant agent", "anti\-line solvent"and"aprotinin formulation"