Evaluating Autologous Stromal Vascular Fraction in Subjects With Vocal Fold Scar

Study Overview
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Brief Summary
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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.

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

Conditions
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Vocal Fold Scars

Intervention / Treatment
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* Biological: Autologous adipose derived SVF


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVF for treating scarred vocal folds<br>Subject identified with scarred vocal folds will have autologous adipose derived SVF harvested and applied to scarred vocal folds. | Biological: Autologous adipose derived SVF<br>* A single dose of autologous adipose derived SVF isolated from adipose tissue will be administered to scarred vocal folds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice handicap Index | Change in the self-reported voice handicap index to describe voices and effects of voices on subject lives, measure using a total score range from 0-120; 0-30=mild, 31-60=moderate, 60-120=severe | Baseline, Week 1, and Months 1, 3, 6, 9, 12, and 24 |