A Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18

Study Overview
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Brief Summary
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To assess the efficacy and safety of the regeneration treatment of tympanic membrane with NPC-18 and FBG-18.

Official Title
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A Phase III Study on the Regenerative Treatment of Tympanic Membrane With NPC-18 and FBG-18-multicenter,Investigator Initiated Clinical Trial

Conditions
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Tympanic Membrane Perforation

Intervention / Treatment
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* Drug: fiblast,gelatin sponge,fibrin glue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed concent obtained At the time of obtaining informed consent, Ages ranged from over 20 to 80 At the time of obtaining informed consent, only those with tympanic membrane perforation in 1 ear (not both) for over 6 months (perforation in both ears is excluded) Exclusion Criteria: TMP caused by burn or radiation therapy In patients with chronic otitis media with ear drum perforation, tympanic cavity are not dry Inflammatory,infection or otorrhea in patient's eardrum,earcanal,middle ear and tympanic cavity No invasion of epithelial and no cholesteatoma in tympanic cavity or around perforated edge History of tympanoplasty A Part of the eardrum adhered to tympanic cavity By temporal bone CT, soft tissue shadow in mastoid antrum or tympanic (using a CT image of less than 12 wks before patients registration) Abnormality in the chain and ear ossicles Air-bone gap difference more than 25dB by patch hearing test Unable to see whole edge of TMP due to narrow external auditory canal Unable to wash out Ear drops during the treatment period Presenting with uncontrolled diabetes (NGSP HbA1c 6.9% and more) Presenting with autoimmune disease History of malignancy within 3 years prior to obtained informed concent Administration of immunosuppressive agent or anti-cancer-agent History of Allergic reaction to local anesthetic(Xylocaine), bFGF(Fiblast spray), fibrin glue(Beriplast P Combi set, etc.), gelatin sponge formulation(spongel) and others 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 solventandaprotinin formulation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPC-18,FBG-18<br>Intervention drug: NPC-18;trafermin(recombination) and gelatin spnge, combination drug FBG-18;fibrin glue Usage:NPC-18 and FBG-18 is administered at the same time for regenerative treatment of tympanic membrane | Drug: fiblast,gelatin sponge,fibrin glue<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of tympanic membrane perforation in the observation period at16 wks |  | Closure of tympanic membrane perforation in the observation period at16 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of tympanic membrane perforation in the observation period at 4 wks |  | Closure of tympanic membrane perforation in the observation period at 4 wks | 
| Improvement of hearing level in the observation period at 4 wks and 16 wks |  | Improvement of hearing level in the observation period at 4 wks and 16 wks | 
| Air-bone gap in the observation period at 4 wks and 16 wks |  | Air-bone gap in the observation period at 4 wks and 16 wks | 
| The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks |  | The difference of the average hearing level of air conduction threshold from the treatment at 0 wk and observation period at 4wks and 6 wks | 
| Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks |  | Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks |