A Pilot Study Evaluating the Safety and Feasibility of Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar

Shane A. Shapiro1 site in 1 country2 target enrollmentAugust 1, 2021

ConditionsVocal Fold Scars

InterventionsAutologous adipose derived SVF

DrugsAutologous adipose derived SVF

Overview

Phase: Phase 1
Intervention: Autologous adipose derived SVF
Conditions: Vocal Fold Scars
Sponsor: Shane A. Shapiro
Enrollment: 2
Locations: 1
Primary Endpoint: Adverse events post SVF administration
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2021

End Date

December 5, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shane A. Shapiro

Responsible Party

Sponsor Investigator

Principal Investigator

Shane A. Shapiro

Regulatory Sponsor

Mayo Clinic

Eligibility Criteria

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

Arms & Interventions

SVF for treating scarred vocal folds

Subject identified with scarred vocal folds will have autologous adipose derived SVF harvested and applied to scarred vocal folds.

Intervention: Autologous adipose derived SVF

Outcomes

Primary Outcomes

Adverse events post SVF administration

Time Frame: 24 months

Number of adverse events related to SVF via endoscopy into vocal folds defined as inflammation or swelling indicated by red or swollen vocal folds or evidence of a hemorrhage indicated by a bleed at or near the site of delivery. This will be evaluated during stroboscope exam.