Clinical Trials

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 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 vocal fold surgery.
• Negative pregnancy test and contraception for woman of child bearing age. Women of child bearing 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 local anesthetics, 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 for or within 6 months of last treatment for cancer;
  • Known history of Dementia;
  • Known history of Kidney Disease;
  • Known history of Cerebral Vascular Accident or Stroke;
  • Known history of Diabetes.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/22/24. Questions regarding updates should be directed to the study team contact.