Study Summary
This trial will study whether fat from a patient's stomach or hips can be used to heal vocal cord scars.
Treatment Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Baseline, Week 1, and Months 1, 3, 6, 9, 12, and 24
Trial Safety
Trial Design
1 Treatment Group
SVF for treating scarred vocal folds
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: Autologous adipose derived SVF · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 65 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Hawaii | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Mayo Clinic in Arizona | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor