Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations

Launched by NYU LANGONE HEALTH · Jul 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called FGF-2 to help heal chronic holes in the eardrum, known as tympanic membrane perforations (TMP). The trial is designed for adults aged 18 and older who have had a dry hole in their eardrum for at least six months. Participants will be randomly chosen to receive either the FGF-2 treatment or a placebo (a non-active treatment) for up to three sessions. If the hole does not close after these treatments, participants who initially received the placebo will have the chance to receive FGF-2 in a later phase of the study.

As a participant, you can expect to have your eardrum’s condition carefully monitored through photographs and regular check-ups to see if the treatment is effective. It’s important to note that certain conditions, such as current ear infections or recent use of certain medications, may prevent someone from joining the study. Overall, this trial could provide new hope for people struggling with healing their eardrum perforations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years and older
• • Dry tympanic membrane perforation of at least 6 months duration
• • Any person of child-bearing potential, must have a negative beta-HCG test and must agree to use an adequate form of birth control throughout the clinical trial.
• Exclusion Criteria:
• • 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 or may be with inflammation.
• • 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
• • Known or suspected allergies to any components used in the study, i.e. porcine collagen
• • Subjects who have cholesteatoma mass, or endothelium invasion 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
• • Subjects who have undergone prior myringoplasty or tympanoplasty
• • Subjects whose TMP is a result of thermal burn, or radiation therapy.
• • Subjects who have abnormalities in the auditory ossicles or their linkages
• • Subjects having moderate to severe dementia such as Alzheimer's disease or senile dementia
• • Subjects whose hearing ability does not improve to bone-conduction hearing on a hearing acuity test using the tentative closure of perforation with a wet cotton ball.
• • Subject having residual TM with abnormal form or abnormal shape anatomically
• • Subjects having any granulation or soft tissue density due to inflammation, or infection in mastoid antrum determined by CT scanning (Temporal bone CT scanning)