Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic membrane as the primary measureable outcome. The goal is to determine the safety and efficacy of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans, it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic membrane perforation. A total of 60 subjects will be recruited.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Bradley Welling
• Collaborator: United States Department of Defense
• Treatments: Mitogens

Criteria

Inclusion Criteria:

1. Dry tympanic membrane perforation of greater than 3 months duration

2. If female, post-menopausal or sterile, or if she is of child-bearing potential, must have a negative beta-human chorionic gonadotropin (HCG) test and must be using an adequate form of birth control such as birth control pills, birth control implants, intrauterine devices (IUDs), diaphragms or condoms.

Exclusion Criteria:

The presence of any of the following excludes a subject from study enrollment:

• Active otitis media or chronic otorrhea from the middle ear

• Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or chemotherapy

• Subjects who, at study entry, are taking systemic antibiotics

• Subjects who are immunosuppressed

• Subjects experiencing bacterial or viral infection or who may otherwise be febrile

• Life expectancy of less than 1 year

• Active alcohol or drug abuse within 6 months prior to study entry

• Significant medical condition that could prevent full participation in the procedures required for the study (See body of protocol for full list of exclusions)

• Known or suspected allergies to any components used in the study

• Subjects who have cholesteatoma mass in the tympanic cavity

• Subjects whose total perforation cannot be seen by an endoscope

• Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher)

• Subjects with a history of malignant ear canal tumors within 3 years of screening for eligibility