Status:
TERMINATED
Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
Lead Sponsor:
Shane A. Shapiro
Conditions:
Vocal Fold Scars
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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 treatment or within 6 months of last treatment for cancer.
- Blindness
- Known history of Dementia,
- Known history of Kidney Disease
- Known history of Cerebral Vascular Accident or Stroke
- Known history of Diabetes
- Abnormal screening lab. If the laboratory reports a single, non-clinically relevant, non-life-threatening result for any of these studies and is the only excluding factor it may be repeated 1 week later if the subject wishes. Normalization of that laboratory study will then be considered non-exclusionary.
- Post-Radiation scarring of vocal folds.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05354544
Start Date
August 1 2021
End Date
December 5 2024
Last Update
December 19 2024
Active Locations (1)
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1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224