Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar

NCT05354544 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 19-006564
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Fold Scars

Outcome Measures

Primary Outcomes (1)

• Adverse events post SVF administration

  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.

  24 months

Secondary Outcomes (1)

• Voice handicap Index

  Baseline, Week 1, and Months 1, 3, 6, 9, 12, and 24

Study Arms (1)

SVF for treating scarred vocal folds

EXPERIMENTAL

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

Biological: Autologous adipose derived SVF

Interventions

Autologous adipose derived SVF BIOLOGICAL

A single dose of autologous adipose derived SVF isolated from adipose tissue will be administered to scarred vocal folds.

SVF for treating scarred vocal folds

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Post-Radiation scarring of vocal folds.

Sponsors & Collaborators

• Shane A. Shapiro: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Amy Rutt, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Sponsor

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: April 29, 2022
• Study Start: August 1, 2021
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-06

Locations

US (1)