What side effects are associated with this type of intervention?

Common treatments for vocal cord paralysis using injectable fillers, such as hyaluronic acid, collagen derivatives, and calcium hydroxyapatite, can have side effects including local inflammation, infection, granuloma formation, and temporary changes in voice quality. Specific to treatments like Renuva, which stimulates adipogenesis using growth factors and collagen, potential side effects may also include hypersensitivity reactions, prolonged edema, and the risk of fat necrosis or calcification. It is important to discuss these risks with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for vocal cord paralysis include various injectable materials such as carbomethylcellulose, hyaluronic acid, collagen derivatives, and calcium hydroxyapatite. These treatments aim to correct glottic insufficiency by augmenting the vocal folds without impairing their fibroelastic properties. While Renuva, an allograft adipose matrix, is being studied for its potential to stimulate adipogenesis using growth factors and collagen, similar FDA-approved treatments focus on integrating within the vocal fold tissue to restore function effectively.

What other types of research exist?

Promising alternatives to Renuva for vocal cord paralysis include carbomethylcellulose, hyaluronic acid, collagen derivatives, and calcium hydroxyapatite. These materials are already used to correct glottic insufficiency and have properties that support tissue integration and maintain fibroelastic properties of the vocal folds.

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Allograft Adipose Injectable

Renuva Injection for Vocal Cord Paralysis

Phase 3

Recruiting

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Be older than 18 years old

Must not have

History of laryngeal surgery

Active infection or inflammation in the larynx (presence of acute laryngeal infection caused by bacteria/virus or fungus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing Renuva, a fat tissue-based filler, on patients with vocal cord issues. The goal is to see if it can safely and effectively improve their voice by stimulating new tissue growth in the vocal cords. Renuva is similar to fat injections that have been used since 1987 for vocal cord treatments.

Who is the study for?

This trial is for adults over 18 with unilateral vocal fold immobility and glottic insufficiency lasting at least two weeks. Participants must consent to follow the study procedures. Pregnant individuals, those with active laryngeal infections or other complex laryngeal conditions, a life expectancy under six months, or allergies to certain anesthetics cannot join.

What is being tested?

The trial is testing Renuva Allograft Adipose Matrix as an injectable treatment for glottic insufficiency caused by vocal fold paralysis. Renuva aims to integrate into the tissue without affecting its natural properties and may stimulate healing through growth factors.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects could include local reactions at the injection site such as swelling, pain, bruising; allergic reactions; and possibly voice changes due to incorrect placement or volume of filler.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my voice box.

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I do not have a current infection or inflammation in my voice box.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of adverse recorded in participants after injection

Secondary study objectives

Dyspnea Index as measured by patient questionnaire

Score on VALI - Voice Vibratory Assessment of laryngeal imaging

Voice outcomes as reported by patient questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Injection of Renuva Allograft adipose matrix in vocal foldExperimental Treatment1 Intervention

Injection of Renuva Allograft Adipose matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Vocal Cord Paralysis, such as carbomethycellulose, hyaluronic acid, collagen derivatives, and calcium hydroxyapatite, work by providing structural support and volume to the vocal folds, thereby improving glottic closure and voice quality. These injectables aim to restore the fibroelastic properties of the vocal fold tissues without impairing their function. Renuva, an allograft adipose matrix, is being studied for its ability to stimulate adipogenesis using growth factors and collagen, which may offer a more integrated and natural augmentation of the vocal folds. This is crucial for patients as it could lead to better voice outcomes and reduced risk of adverse effects.