Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-18

Study Completion Date

2022-09-30

Brief Summary

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This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency

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Detailed Description

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Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. These modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. The investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (PRP) injection for vocal fold atrophy, sulcus vocalis and scar. PRP is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. Patients with vocal fold atrophy, sulcus vocalis, and scar identified in the USC Voice Center will be offered participation in a study to receive serial PRP injections in one vocal fold. Outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. The investigators hypothesize that serial PRP injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.

Conditions

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Presbylarynx Atrophy; Larynx Dysphonia Vocal Cord Atrophy Presbylarynges Vocal Fold Scar Sulcus Vocalis of Vocal Cord

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Serial monthly vocal fold injections with PRP for total of 4 injections.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Serial PRP injections

This arm will receive experimental intervention of serial monthly platelet-rich plasma (PRP) injections to a unilateral vocal fold mucosa for a total of 4 injections.

Group Type EXPERIMENTAL

Serial PRP injections

Intervention Type PROCEDURE

Autologous platelet-rich plasma will be injected into the vocal fold mucosa in a serial fashion, once per month for a total of 4 injections.

Interventions

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Serial PRP injections

Autologous platelet-rich plasma will be injected into the vocal fold mucosa in a serial fashion, once per month for a total of 4 injections.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
* Patients with a pre-injection VHI-10 score of ≥ 10
* Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
* Ability to give informed consent

Exclusion Criteria

* Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
* Current smoker
* Underlying coagulopathy, thrombocytopenia, or platelet dysfunction

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No