NCT03749863

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2020-02-18
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2018-11-21
• Last updated: 2023-05-10

Locations

1 site across 1 country: United States