Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy



Status:Not yet recruiting
Healthy:No
Age Range:60 - Any
Updated:4/6/2019
Start Date:May 1, 2019
End Date:April 30, 2021
Contact:Michael Johns, MD
Email:michael.johns@med.usc.edu
Phone:323-442-5577

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Safety and Efficacy of Serial Platelet-Rich Plasma Injections for Treatment of Vocal Fold Atrophy

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.

Vocal fold atrophy and resulting dysphonia (also known as presbyphonia) 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 age-related vocal fold
atrophy. 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 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 volume, morphology, and dysphonia in
these patients with no adverse side effects.

Inclusion Criteria:

- Vocal fold atrophy 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

- History of laryngeal surgery

- Current smoker

- Underlying coagulopathy, thrombocytopenia, or platelet dysfunction

- Underlying autoimmune disease, cancer, liver disease, or respiratory compromise

- Allergy to cow products.
We found this trial at
1
site
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Michael Johns, MD
Phone: 323-478-3248
University of Southern California The University of Southern California is one of the world’s leading...
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