Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
NCT ID: NCT05354544
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2021-08-01
2024-12-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Autologous adipose derived SVF
A single dose of autologous adipose derived SVF isolated from adipose tissue will be administered to scarred vocal folds.
Interventions
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Autologous adipose derived SVF
A single dose of autologous adipose derived SVF isolated from adipose tissue will be administered to scarred vocal folds.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Shane A. Shapiro
OTHER
Responsible Party
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Shane A. Shapiro
Regulatory Sponsor
Principal Investigators
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Amy Rutt, DO
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-006564
Identifier Type: -
Identifier Source: org_study_id