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

NCT03749863 | Completed

• 1 other identifier: APP-18-05224
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

presbyphonia; presbylarynx; vocal fold atrophy; dysphonia; platelet rich plasma; PRP; vocal fold scar

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale

  Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening

  4 months

Secondary Outcomes (3)

• Voice-Related Quality of Life as assessed by Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI)

  4 months

• Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument

  4 months

• Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form

  4 months

Study Arms (1)

Serial PRP injections

EXPERIMENTAL

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.

Procedure: Serial PRP injections

Interventions

Serial PRP injections 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.

Serial PRP injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (5)

• Bradley JP, Hapner E, Johns MM 3rd. What is the optimal treatment for presbyphonia? Laryngoscope. 2014 Nov;124(11):2439-40. doi: 10.1002/lary.24642. Epub 2014 Aug 5. No abstract available.

  PMID: 25132245 BACKGROUND

• Crawley BK, Dehom S, Thiel C, Yang J, Cragoe A, Mousselli I, Krishna P, Murry T. Assessment of Clinical and Social Characteristics That Distinguish Presbylaryngis From Pathologic Presbyphonia in Elderly Individuals. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):566-571. doi: 10.1001/jamaoto.2018.0409.

  PMID: 29799925 BACKGROUND

• Cobden SB, Ozturk K, Duman S, Esen H, Aktan TM, Avunduk MC, Elsurer C. Treatment of Acute Vocal Fold Injury With Platelet-Rich Plasma. J Voice. 2016 Nov;30(6):731-735. doi: 10.1016/j.jvoice.2015.07.012. Epub 2015 Aug 17.

  PMID: 26292799 BACKGROUND

• Woo SH, Jeong HS, Kim JP, Koh EH, Lee SU, Jin SM, Kim DH, Sohn JH, Lee SH. Favorable vocal fold wound healing induced by platelet-rich plasma injection. Clin Exp Otorhinolaryngol. 2014 Mar;7(1):47-52. doi: 10.3342/ceo.2014.7.1.47. Epub 2014 Feb 5.

  PMID: 24587881 BACKGROUND

• Ozgursoy SK, Tunckasik F, Tunckasik ME, Akincioglu E, Dogan H, Beriat GK. Histopathologic Evaluation of Hyaluronic Acid and Plasma-Rich Platelet Injection into Rabbit Vocal Cords: An Experimental Study. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):30-35. doi: 10.5152/tao.2018.2942. Epub 2018 Mar 1.

  PMID: 29988271 BACKGROUND

MeSH Terms

Conditions

Atrophy; Laryngeal Diseases; Dysphonia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Voice Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Michael Johns, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Otolaryngology-Head and Neck Surgery; Director, USC Voice Center

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

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: November 21, 2018
• Study Start: February 18, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: May 10, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)