Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar

Shane A. Shapiro

Status and phase

Terminated

Phase 1

Conditions

Vocal Fold Scars

Treatments

Biological: Autologous adipose derived SVF

Study type

Interventional

Funder types

Other

Identifiers

NCT05354544

19-006564

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 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.