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

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

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test if injecting a special substance from a patient's own blood into their vocal cords can help improve voice problems caused by aging or damage. The treatment aims to use the body's natural healing abilities to repair and strengthen the vocal cords.

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.

What data supports the effectiveness of the treatment Serial PRP injections?

Research shows that platelet-rich plasma (PRP) injections can help reduce pain and improve function in people with knee osteoarthritis, and similar benefits have been observed in treating shoulder conditions. This suggests that PRP injections might be effective for other joint-related issues as well. ^{1 2 3 4 5}

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. Italy pubmed.ncbi.nlm.nih.gov

The effect of intra-articular allogenic platelet rich plasma in Dunkin-Hartley guinea pig model of knee osteoarthritis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Clinical outcome and risk factor predictive for failure of autologous PRP injections for low-to-moderate knee osteoarthritis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Short-term clinical results of intra-articular PRP injections for early osteoarthritis of the knee. [2018]

5. Korea (South) 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. [2022]