Evaluating Autologous Stromal Vascular Fraction in Subjec... | NCT05354544

NCT05354544

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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.