Allograft Adipose Injectable for Vocal Fold Paralysis

Description

Renuva is allograft adipose matrix commonly used as a filler in cosmetic procedures. The investigators are studying this material as an injectable in the vocal fold to treat glottic insufficiency. Currently, many products can be used as an injectable in the vocal fold to correct glottic insufficiency such as carbomethycellulose, hyaluronic acid, collagen derivatives and calcium hydroxyapatite amongst others. An ideal injectable would not impair the fibroelastic property of the vocal fold tissues and would integrate within the tissue of the vocal fold. Since Renuva has the property of stimulating adipogenesis by using growth factor and collagen, the investigators believe it could represent a good option in terms of safety and efficacy for vocal fold augmentation. This study will assess the safety and efficacy of Renuva as a vocal fold injectable to treat glottic insufficiency.

Conditions

Vocal Fold Palsy

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Study Overview

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Study Details

Study overview

Renuva is allograft adipose matrix commonly used as a filler in cosmetic procedures. The investigators are studying this material as an injectable in the vocal fold to treat glottic insufficiency. Currently, many products can be used as an injectable in the vocal fold to correct glottic insufficiency such as carbomethycellulose, hyaluronic acid, collagen derivatives and calcium hydroxyapatite amongst others. An ideal injectable would not impair the fibroelastic property of the vocal fold tissues and would integrate within the tissue of the vocal fold. Since Renuva has the property of stimulating adipogenesis by using growth factor and collagen, the investigators believe it could represent a good option in terms of safety and efficacy for vocal fold augmentation. This study will assess the safety and efficacy of Renuva as a vocal fold injectable to treat glottic insufficiency.

Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency

Allograft Adipose Injectable for Vocal Fold Paralysis

Condition
Vocal Fold Palsy
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * • Age ≥ 18 years old
  • * Unilateral vocal fold immobility with glottal insufficiency present for at least 2 weeks from onset
  • * Willingness to partake in study and follow-up as documented by signed informed consent
  • * History of allergy/hypersensitivity to lidocaine or amide-based anesthetics
  • * Pregnancy
  • * Active infection or inflammation in the larynx (presence of acute laryngeal infection caused by bacteria/virus or fungus)
  • * Comorbid known laryngeal conditions including but not limited to vocal fold scar, vocal tremor, laryngeal dystonia, etc. that would warrant other interventions for optimal treatment
  • * History of laryngeal surgery
  • * Life expectancy of less than 6 months

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

Study Record Dates

2025-07-01