Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar (NCT05354544) | Clinical Trial Compass
TerminatedPhase 1
Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
Stopped: Funding loss
United States2 participantsStarted 2021-08-01
Plain-language summary
The purpose of this research study is to assess if autologous Stromal Vascular Fraction (SVF) taken from the stomach or hips can help heal vocal fold scars.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent
* Subject's age between 18 and \< 80-years-old
* Voice handicap index greater than 10/40
* Scarred vocal folds or congenital sulcus or after vocal fold surgery (Scarring will be scored during examination and identification of scarred vocal folds and hoarseness. This criterion includes the lack of or decreased mucosal wave of the vocal fold during videostroboscopy exam. Scoring of scar based on laryngoscopic exam: Type I: atrophy of lamina propria with/without affected epithelium. Type II: the epithelium, lamina propria, and muscle are affected. Type III: scar located on the anterior commissure. Type IV: this category includes extended scar formation in both anteroposterior and rostro-caudal axis, with significant loss of vocal fold mass)
* Unilateral or Bilateral vocal fold scarring
* At least 1-year delay after initial surgery
* Negative pregnancy test and contraception for woman of childbearing age. Women of childbearing age must use contraception at least 4 months pre and post SVF administration.
Exclusion Criteria:
* Refusal of speech therapy
* History of malignant lesion or severe dysplasia of the scarred vocal fold
* Contraindication to anesthesia, anticoagulant treatment, coagulation disorders, active infectious disease
* Refusal or inability to comply with study procedures
* Pregnant and lactating woman
* Major chronic medical condition that could affect treatment or quality of SVF product. These include:
* Current t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.