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

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Completed; Phase 3

Conditions: Tympanic Membrane Perforation

Treatments: Drug: fiblast,gelatin sponge,fibrin glue

Study type: Interventional

Funder types: Other

Identifiers

NCT02550314

TRIENT1328

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

NPC-18,FBG-18

Experimental group

Description:

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

Treatment:

Drug: fiblast,gelatin sponge,fibrin glue