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Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
N/A
Waitlist Available
Led By Michael Johns, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Voice Disorder
- Vocal Fold Scar
- Presbylarynx
- Hoarseness
- Laryngeal Atrophy
- Vocal Cord Atrophy
- Presbylarynges
- Sulcus Vocalis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale
Secondary study objectives
Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument
Diagnostic Imaging
Voice-Related Quality of Life as assessed by Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Serial PRP injectionsExperimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Serial PRP injections
2020
N/A
~20
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,809 Total Patients Enrolled
Michael Johns, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
18 Total Patients Enrolled