Platelet-Rich Plasma Injections for Vocal Cord Atrophy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Smoking, Coagulopathy, Thrombocytopenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether platelet-rich plasma (PRP) injections can improve voice issues caused by vocal fold problems such as thinning, scarring, or sulcus vocalis (a groove in the vocal cord). The main goal is to determine if these injections are safe and effective for individuals with voice difficulties due to these conditions. Participants receive four monthly injections directly into the vocal cords. Individuals diagnosed with these specific vocal fold issues by a throat specialist and who experience significant voice problems may be suitable for the trial. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatments for vocal fold issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that platelet-rich plasma (PRP) injections are generally safe for treating vocal cord issues. These injections use a part of the patient's own blood and typically don't cause swelling or scarring. Studies on both animals and humans have not reported any major negative reactions. Overall, PRP is considered a safe option for treating problems like vocal cord scars. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for vocal fold atrophy, scar, or sulcus vocalis, which often involve surgical intervention or voice therapy, serial PRP (platelet-rich plasma) injections use components from your own blood to potentially regenerate vocal fold tissue. This treatment is unique because it harnesses the body's natural healing processes, aiming to repair and rejuvenate the vocal folds at a cellular level. Researchers are excited about this approach because it could offer a less invasive alternative with fewer side effects, and it might improve vocal quality by directly addressing tissue health rather than just compensating for damage.

What evidence suggests that serial PRP injections might be an effective treatment for dysphonia?

Research has shown that platelet-rich plasma (PRP) injections can greatly improve voice quality in people with vocal cord issues. One study found that 73.4% of participants experienced better voice quality after treatment, with voice problem scores dropping by an average of 18.8 points. Another study demonstrated that PRP injections were both effective and safe for treating vocal cord scars and age-related voice changes. Additionally, a single PRP injection improved voice quality for up to 12 months. This trial will specifically evaluate the effects of serial monthly PRP injections, administered to a unilateral vocal fold mucosa for a total of four injections. Overall, PRP injections appear to be a promising treatment for vocal cord problems. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael Johns, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

Inclusion Criteria

Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist

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

You currently smoke cigarettes or use tobacco products.

Underlying coagulopathy, thrombocytopenia, or platelet dysfunction

You have an existing condition in your throat that could make it unsafe or less effective to receive PRP injection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four serial monthly vocal fold injections of platelet-rich plasma

4 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of voice quality and laryngeal videostroboscopy exams

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Serial PRP injections

How Is the Trial Designed?

Group I: Serial PRP injections Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

Autologous platelet-rich plasma (PRP) injections significantly improve pain relief and functional outcomes in patients with common shoulder diseases compared to placebo and corticosteroid injections, based on an analysis of 17 randomized controlled trials.

PRP injections also enhance quality of life (QoL) for patients, with the most effective results seen when PRP is prepared using specific techniques, such as double centrifugation and high platelet concentration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can platelet-rich plasma injections provide better pain relief and functional outcomes in persons with common shoulder diseases: a meta-analysis of randomized controlled trials. Barman, A., Mishra, A., Maiti, R., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39115162/

Prospective Outcomes After Serial Platelet-Rich Plasma (PRP ... The raters observed an improvement in post-treatment voice in 73.4% of cases, and CAPE-V scores showed a reduction of 18.8 points on average (p ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0892199725001079

Retrospective Analysis of Short-Term Responses to PRP ... PRP injections demonstrate promising efficacy and safety in vocal fold scars and presbylaryngis treatment, with a significant improvement in perceptual voice ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lary.70117

Single Platelet Rich Plasma Glottic Injections in Vocal ... Single PRP injection of the VF can provide significant improvement in vocal parameters in individuals with benign VF pathology out to 12 months.

4. link.springer.com link.springer.com/article/10.1007/s00405-024-08824-5

Platelet Rich plasma injection of the vocal folds in benign ... Current human studies of the use of PRP in the VFs, show improvement in phonatory outcomes out to 1 year after PRP injections, with small cohort ...

5. enttoday.org enttoday.org/article/platelet-rich-plasma-injections-promising-treatment-option-for-patients-with-vocal-fold-scar-and-sulcus/

Platelet-Rich Plasma Injections Promising Treatment ... PRP injections resulted in improved patient-reported outcome measures and auditory–perceptual measures of voice and are a promising treatment option for vocal ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/lary.31683

Prospective Outcomes After Serial Platelet‐Rich Plasma ... PRP has been validated as a safe autologous option for treatment of vocal fold scar. While results for mucosal wave and voice quality varied, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199721000126

Platelet-Rich Plasma for Vocal Fold Scar: A Preliminary ... The ongoing clinical trial will provide additional data to assess the safety and therapeutic benefit of serial PRP injections. Recommended articles ...

8. ctv.veeva.com ctv.veeva.com/study/serial-platelet-rich-plasma-injections-for-vocal-fold-atrophy-scar-and-or-sulcus-vocalis

Serial Platelet-Rich Plasma Injections for 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 ...