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

Phase 3

Completed

• Conditions: Tympanic Membrane Perforation
• Interventions: Drug: fiblast,gelatin sponge,fibrin glue

• Registration Number: NCT02550314
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Primary Completion: 2016-05
• Study Completion: 2016-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Written informed concent obtained
2. At the time of obtaining informed consent, Ages ranged from over 20 to 80
3. 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

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NPC-18,FBG-18	fiblast,gelatin sponge,fibrin glue	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Closure of tympanic membrane perforation in the observation period at 4 wks	Closure of tympanic membrane perforation in the observation period at 4 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