Status:
COMPLETED
Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
Lead Sponsor:
D. Bradley Welling, MD, PhD
Collaborating Sponsors:
United States Department of Defense
Conditions:
Tympanic Membrane Perforation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
A Phase II randomized trial will be initiated to evaluate efficacy as the primary measureable outcome. Eligible and consented patients will be randomized in a 3:1 ratio to the optimal biologic dose (O...
Eligibility Criteria
Inclusion
- Dry tympanic membrane perforation of greater than 3 months duration
- 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
- 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
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02307916
Start Date
October 1 2016
End Date
March 1 2020
Last Update
December 8 2025
Active Locations (2)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
2
Wilford Hall, Lackland Airforce Base
Lackland City, Texas, United States, 78236