Renuva Injection for Vocal Cord Paralysis

Overseen By Karla O'Dell, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Southern California

Disqualifiers: Pregnancy, Laryngeal infection, Laryngeal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Renuva Allograft Adipose Matrix for vocal cord paralysis?

Research on similar treatments, like autologous fat injections and adipose-derived regenerative cells, shows they can improve voice quality and quality of life in patients with vocal cord paralysis by filling gaps and supporting tissue healing. ^{1 2 3 4 5}

Is Renuva Injection safe for use in humans?

Research on similar treatments, like human adipose-derived extracellular matrix (ECM) and autologous fat injections, suggests they are generally safe for vocal fold augmentation, showing no significant inflammation or complications in studies. ^{1 6 7 8 9}

How is the Renuva treatment different from other treatments for vocal cord paralysis?

Renuva is unique because it uses an allograft adipose matrix, which is derived from human fat tissue, to enhance vocal function without the early resorption and morbidity associated with autologous fat injections. This treatment offers greater biostability and avoids the need for liposuction, making it a promising option for stable vocal fold augmentation. ^{1 6 7 10 11}

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My voice box has been partly paralyzed for at least 2 weeks.

Willingness to partake in study and follow-up as documented by signed informed consent

Exclusion Criteria

You have had an allergic reaction to lidocaine or similar numbing medicines.

I have had surgery on my voice box.

I have a known throat condition that needs different treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a unilateral injection augmentation with allograft adipose matrix injectable (Renuva) in the vocal fold

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 0, 1, 3, 6, 12, and 18 months

18 months

6 visits (in-person)

Treatment Details

Interventions

• Renuva Allograft Adipose Matrix

Trial Overview 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.

Participant Groups

Group I: Injection of Renuva Allograft adipose matrix in vocal fold Experimental Treatment 1 Intervention

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

Renuva Allograft Adipose Matrix is already approved in United States for the following indications:

Approved in United States as Renuva for:

• Cosmetic procedures
• Vocal fold paralysis/glottic insufficiency (investigational)

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

In a study of 14 patients with unilateral vocal cord paralysis, injection laryngoplasty using micronized AlloDerm significantly improved voice quality, with habitual phonation time increasing from 3.84 to 6.72 seconds and a notable reduction in voice handicap index scores.

The procedure demonstrated a high safety profile, with minimal morbidity and tissue reaction, and 87.5% of patients maintained excellent voice quality at 3 months post-injection, despite some resorption of the material.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary report on micronized AlloDerm injection laryngoplasty. Pearl, AW., Woo, P., Ostrowski, R., et al.[2022]

In a study of 21 patients with unilateral vocal cord paralysis and cordectomy defects, autologous fat injections led to significant improvements in voice quality and phonatory functions over a mean follow-up of 14 months.

The treatment was particularly effective for patients with unilateral vocal cord paralysis, with 15 out of 18 patients experiencing improvement in swallowing symptoms, indicating its potential as a viable intervention for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term results of intracordal or neocordal autologous fat injection in patients with unilateral vocal cord paralysis and cordectomy]. Güven, M., Demir, D., Süoğlu, Y., et al.[2019]

The study shows that ADRC-enriched fat grafts are a safe and effective treatment for glottal gap defects caused by unilateral vocal fold paralysis, with significant improvements in patients' self-perceived voice quality after treatment.

Patients receiving ADRC-enriched grafts reported greater improvements in their voice quality compared to those receiving standard centrifuged autologous fat, indicating a potential advantage of using ADRCs in vocal fold reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection Laryngoplasty Using Autologous Fat Enriched with Adipose-Derived Regenerative Stem Cells: A Safe Therapeutic Option for the Functional Reconstruction of the Glottal Gap after Unilateral Vocal Fold Paralysis. Lasso, JM., Poletti, D., Scola, B., et al.[2022]

Bilateral vocal fold injection with autologous fat significantly improves voice outcomes in patients with vocal fold atrophy, showing a clinically relevant reduction in the Voice Handicap Index (VHI-30) from 49.1 to 29.7 points after 12 months.

The treatment is effective for both vocal fold atrophy and atrophy with sulcus, with no significant differences in voice improvement between these groups, indicating its broad applicability for voice restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral vocal fold injection with autologous fat in patients with vocal fold atrophy with or without sulcus. van den Broek, EMJM., Heijnen, BJ., Hendriksma, M., et al.[2021]

In a study of 34 patients with unilateral vocal fold paralysis (UVFP) following thoracic surgery, a single office-based injection of hyaluronate (HA) significantly improved voice quality and overall quality of life within one month, indicating its efficacy as a treatment.

The procedure was found to be safe, with no reported complications related to the HA injection, making it a viable option for patients suffering from UVFP after thoracic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Office-Based Intracordal Hyaluronate Injections Improve Quality of Life in Thoracic-Surgery-Related Unilateral Vocal Fold Paralysis. Fang, TJ., Hsin, LJ., Chung, HF., et al.[2022]

The injectable hydrogel made from adipose-derived soluble extracellular matrix (sECM) and methylcellulose (MC) provides stable vocal fold augmentation, enhancing vocal function in cases of vocal fold paralysis without the issues of early resorption seen with autologous fat.

This new hydrogel showed promising results in maintaining vocal fold symmetry and reducing inflammation or fibrosis at the injection site, making it a safer and more effective alternative for injection laryngoplasty compared to traditional fat grafting methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Adipose Tissue Derived Extracellular Matrix and Methylcellulose Hydrogels Augments and Regenerates the Paralyzed Vocal Fold. Kim, DW., Kim, EJ., Kim, EN., et al.[2018]

Fat injection (FI) is a safe and effective treatment for vocal fold atrophy (VFA) and sulcus vergeture (SVER), with excellent results seen in nearly half of the patients treated for these conditions.

Patients with sulcus vocalis (SV) had lower success rates, but those treated more recently had a significantly higher chance of achieving excellent outcomes, highlighting the importance of timing and experience in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autogenous fat injection for glottic insufficiency: analysis of 101 cases and correlation with patients' self-assessment. Hsiung, MW., Pai, L.[2006]

Adipose-derived stem cells (ASC) showed good adhesion and proliferation on micronized acellular dermal matrix (MADM), indicating that MADM is a compatible scaffold for vocal cord tissue.

The ASC-MADM complex can be safely injected into rabbit vocal cords, where the ASC survived for up to 8 weeks without causing any adverse reactions or inflammatory responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experimental study on adipose-derived stem cells combined with acellular dermal matrix particles for vocal fold injection]. Liang, Q., Liu, Y., Deng, ZH., et al.[2011]

The use of an injectable collagen scaffold significantly improved the retention and survival of autologous fat cells in a rat model, suggesting it could enhance cell therapy for vocal fold injuries.

In a clinical trial with 10 patients, the combination of autologous fat cells and collagen scaffold led to better voice quality outcomes compared to fat cells alone, with no complications reported over 24 months, indicating both safety and efficacy of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical study of injectable collagen scaffold with autologous fat cells for repair of severe vocal fold injury. Jin, X., Liu, W., Wang, J., et al.[2023]

Micronized acellular dermal matrix (MADM) significantly enhances the proliferation and survival of adipose-derived stem cells (ADSCs) compared to traditional two-dimensional cultures, making it a promising substrate for cell therapy.

In a rabbit model of vocal fold injury, the combination of ADSCs with MADM (ADSC-MADM) effectively prevents scarring and atrophy, demonstrating superior therapeutic effects over using ADSCs or MADM alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micronized acellular dermal matrix as an efficient expansion substrate and delivery vehicle of adipose-derived stem cells for vocal fold regeneration. Liang, Q., Liu, S., Han, P., et al.[2012]

Vocal fold injection has seen a resurgence in use due to advancements in technology and techniques, allowing for awake, un-sedated procedures that provide distinct advantages for treating conditions like vocal fold paralysis and atrophy.

With appropriate selection of patients and materials, vocal fold injection has become a key treatment option for dysphonia, offering a less invasive alternative compared to traditional laryngeal framework surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vocal fold injection: review of indications, techniques, and materials for augmentation. Mallur, PS., Rosen, CA.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A preliminary report on micronized AlloDerm injection laryngoplasty. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

[Long-term results of intracordal or neocordal autologous fat injection in patients with unilateral vocal cord paralysis and cordectomy]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Injection Laryngoplasty Using Autologous Fat Enriched with Adipose-Derived Regenerative Stem Cells: A Safe Therapeutic Option for the Functional Reconstruction of the Glottal Gap after Unilateral Vocal Fold Paralysis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Bilateral vocal fold injection with autologous fat in patients with vocal fold atrophy with or without sulcus. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Office-Based Intracordal Hyaluronate Injections Improve Quality of Life in Thoracic-Surgery-Related Unilateral Vocal Fold Paralysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Human Adipose Tissue Derived Extracellular Matrix and Methylcellulose Hydrogels Augments and Regenerates the Paralyzed Vocal Fold. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Autogenous fat injection for glottic insufficiency: analysis of 101 cases and correlation with patients' self-assessment. [2006]

8. China pubmed.ncbi.nlm.nih.gov

[Experimental study on adipose-derived stem cells combined with acellular dermal matrix particles for vocal fold injection]. [2011]

9. England pubmed.ncbi.nlm.nih.gov

Clinical study of injectable collagen scaffold with autologous fat cells for repair of severe vocal fold injury. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Micronized acellular dermal matrix as an efficient expansion substrate and delivery vehicle of adipose-derived stem cells for vocal fold regeneration. [2012]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Vocal fold injection: review of indications, techniques, and materials for augmentation. [2022]