Clinical trial NCT05354544: Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
Official title: A Pilot Study Evaluating the Safety and Feasibility of Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Vocal Fold Scars
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Adverse events post SVF administration
timeFrame: 24 months
Secondary outcomes:
measure: Voice handicap Index
timeFrame: Baseline, Week 1, and Months 1, 3, 6, 9, 12, and 24
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Amy Rutt, DO
role: PRINCIPAL_INVESTIGATOR
References: