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CompletedNCT02550314Updated Dec 22, 2016

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

A Phase 3 interventional study of fiblast,gelatin sponge,fibrin glue in Tympanic Membrane Perforation, sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-22.

Sponsored by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Tympanic Membrane Perforation
03

In context

Tympanic Membrane Perforation

45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.

This study's enrollment of 20 is below the median of 57 across 31 interventional studies indexed under Tympanic Membrane Perforation.

Browse Tympanic Membrane Perforation studies →

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan is the lead sponsor of 55 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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"
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    NPC-18,FBG-18

    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

Interventions

  • Drugfiblast,gelatin sponge,fibrin glue
06

What researchers measure

Primary outcomes

  1. Closure of tympanic membrane perforation in the observation period at16 wks

    Time frame: Closure of tympanic membrane perforation in the observation period at16 wks

Secondary outcomes

  1. Closure of tympanic membrane perforation in the observation period at 4 wks

    Time frame: Closure of tympanic membrane perforation in the observation period at 4 wks

  2. Improvement of hearing level in the observation period at 4 wks and 16 wks

    Time frame: Improvement of hearing level in the observation period at 4 wks and 16 wks

  3. Air-bone gap in the observation period at 4 wks and 16 wks

    Time frame: Air-bone gap in the observation period at 4 wks and 16 wks

  4. 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

    Time frame: 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

  5. Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks

    Time frame: Average hearing level of air conduction threshold in the observation period at 4 wks and 16 wks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02550314
Lead sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Responsible party
Shin-ichi Kanemaru (director, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan) — Principal investigator
First posted
Sep 15, 2015
Start date
Mar 2015
Primary completion
May 2016
Completion
Jul 2016
Last update
Dec 22, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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

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