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Autologous SVF for Vocal Fold Scarring
Study Summary
This trial will study whether fat from a patient's stomach or hips can be used to heal vocal cord scars.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- It has been over a year since my initial surgery.I am between 18 and 79 years old.I am unable or unwilling to follow the study's procedures.I am not pregnant and will use contraception before and after treatment.I have chosen not to undergo speech therapy.I have scarring on one or both of my vocal cords.My vocal cords are scarred or I've had surgery on them.I have had cancer or severe cell changes in my scarred vocal cord.I do not have issues with anesthesia, bleeding disorders, or active infections.I do not have major health issues that could interfere with the treatment.
- Group 1: SVF for treating scarred vocal folds
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any current opportunities to enroll in this experiment?
"As per the information hosted on clinicaltrials.gov, no new participants are required for this trial at present. First published on November 1st 2022 and last updated in August of the same year; while there is no recruitment taking place, a separate medical study has opened up signups recently."
Who is most suitable for inclusion in this clinical investigation?
"This clinical trial is seeking 12 individuals, aged 18 to 65 with vocal fold scars. Additionally, these patients must have a voice handicap index of at least 60/120 and the scarring must be scored based on laryngoscopic examination (Type I-IV). Informed consent from each participant is needed alongside verification that no woman of childbearing age are pregnant or will become so 4 months prior to and post SVF administration."
How does Autologous adipose derived SVF affect patient safety?
"Autologous adipose derived SVF is estimated to have a safety score of 1 due to the limited evidence supporting its efficacy and lack of data regarding its potential risks, as this is currently just in Phase 1."
Does this clinical trial have an age restriction, and if so what is the upper limit?
"As outlined in the study's enrollment criteria, only those individuals aged between 18 and 65 are eligible to take part."
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