Vocal Fold PalsyPhase 3NCT04700566
Allograft Adipose Injectable for Vocal Fold Paralysis
A Phase 3 study testing Renuva Allograft Adipose Matrix in people with Vocal Fold Palsy, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Fold Palsy
- What is being tested?
- Renuva Allograft Adipose Matrix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 1 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
Karla O'Dell, 323-442-5790, kodell@usc.edu
Michael Johns, 3234425790, michael.johna@med.usc.edu
About this study
Official title: Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency
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.
Read more
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.
Read the detailed description
Background/Significance:
Vocal cord injection augmentation is commonly used to treat glottal insufficiency. Various materials are used for injection augmentation including autologous fat, hyaluronic acid, collagen, carboxymethylcellulose, and calcium hydroxyapatite. However, all of the current injection choices have individual limitations such as temporary effect, unpredictability due to variable resorption by the body, unfavorable mechanical properties, and challenging handling attributes. Hence, there is a need for a more ideal injection augmentation substance that is biocompatible, nonimmunogenic, able to traverse small gauge needles, easy to use, and facilitates long term or permanent effect when desired.
Intervention:
Unilateral injection augmentation with allograft adipose matrix injectable. Renuva ®, is commonly used as in injectable material in plastic surgery for treatment of small cosmetic irregularities. The injectable stimulates adipogenesis using key matrix proteins including collagen IV, collagen VI, FGF-2, and VEGF. The injectable does not contain any lipids, cellular fragments, or DNA content. In vitro and in vivo demonstrate that the injectable can stimulate adipose tissue generation. Given this important quality, allograft adipose matrix may provide vocal fold bulk for a longer period of time with favorable viscoelastic properties which would make it a desirable agent for vocal fold augmentation.
Objective:
Assess the safety profile and efficacy of allograft adipose matrix for use in injection augmentation Study Design: Single arm prospective clinical trial.
Methods:
50 patients with glottal insufficiency will be enrolled to receive vocal fold augmentation injection using an Allograft adipose matrix, commercially available as Renuva ® over a 24 months recruitment period.
Study endpoints:
Primary study endpoint will be the completion of 12 months of follow up post injection with safety monitoring. Secondary endpoints will include patient reported outcome measures (VHI, VFI, DI and EAT-10), blinded Cape-V voice assessment by experts and laryngeal videostroboscopy blinded assessment with the mVali tool.
Plan for analysis:
The study cohort will be analyzed via descriptive statistics of the primary outcome (safety) via incidence of both minor and major adverse events. Non-parametric statistics (Wilcoxon signed-rank test) will be used for comparisons of patient reported outcome measures and blinded evaluations of voice and videostroboscopy endpoints from post-intervention time points to pre-intervention baseline.
- Conditions
- Vocal Fold Palsy
- Being tested
- Renuva Allograft Adipose Matrix
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renuva Allograft Adipose MatrixBiological
Injection of Renuva Allograft adipose Matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency
| Study group | Role | What they receive |
|---|---|---|
| Injection of Renuva Allograft adipose matrix in vocal fold | Experimental | Injection of Renuva Allograft Adipose matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency Receives: Biological: Renuva Allograft Adipose Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse recorded in participants after injection
Monitoring of adverse events during the study period for each participant receiving a vocal fold injection with Renuva
Measured: 18 months
Secondary outcomes (3)
Voice outcomes as reported by patient questionnaire
Voice Handicap Index (VHI-10) patient questionnaire at 0, 1, 3, 6, 12, and 18 months
Measured: 18 months
Score on VALI - Voice Vibratory Assessment of laryngeal imaging
Physician assessment of the stroboscopic examination (blinded) using the VALI scaleat day 0, and post injection 1, 3, 6, 12, and 18 months
Measured: 18 months
Dyspnea Index as measured by patient questionnaire
Dyspnea index questionnaired, filled at 0, 1months, 3 months, 6 months, 12 months, 18 months
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start16 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocal Fold PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, prospective, interventional clinical trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla O'Dell, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700566
- Sponsor's protocol ID
- HS-19-00876
- Status last verified
- Feb 2023
- First submitted
- 4 Jan 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Santa Maria C, Shuman EA, Bensoussan YE, Bhatt NK, Morgan J, Rodman J, La Forest K, Timmons-Sund L, Johns MM 3rd, O'Dell K. Prospective Short-Term Outcomes of Allograft Adipose Matrix (AAM) for Vocal Fold Augmentation. Laryngoscope. 2026 Apr;136(4):1808-1814. doi: 10.1002/lary.70240. Epub 2025 Nov 6.
PubMed 41195694
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Allograft Adipose Matrix Injectable for Glottal Insufficiency
- ClinicalTrials.gov ID
- NCT04700566
- Acronym / sponsor ID
- HS-19-00876
- Conditions
- Vocal Fold Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background/Significance:
Vocal cord injection augmentation is commonly used to treat glottal insufficiency. Various materials are used for injection augmentation including autologous fat, hyaluronic acid, collagen, carboxymethylcellulose, and calcium hydroxyapatite. However, all of the current injection choices have individual limitations such as temporary effect, unpredictability due to variable resorption by the body, unfavorable mechanical properties, and challenging handling attributes. Hence, there is a need for a more ideal injection augmentation substance that is biocompatible, nonimmunogenic, able to traverse small gauge needles, easy to use, and facilitates long term or permanent effect when desired.
Intervention:
Unilateral injection augmentation with allograft adipose matrix injectable. Renuva ®, is commonly used as in injectable material in plastic surgery for treatment of small cosmetic irregularities. The injectable stimulates adipogenesis using key matrix proteins including collagen IV, collagen VI, FGF-2, and VEGF. The injectable does not contain any lipids, cellular fragments, or DNA content. In vitro and in vivo demonstrate that the injectable can stimulate adipose tissue generation. Given this important quality, allograft adipose matrix may provide vocal fold bulk for a longer period of time with favorable viscoelastic properties which would make it a desirable agent for vocal fold augmentation.
Objective:
Assess the safety profile and efficacy of allograft adipose matrix for use in injection augmentation Study Design: Single arm prospective clinical trial.
Methods:
50 patients with glottal insufficiency will be enrolled to receive vocal fold augmentation injection using an Allograft adipose matrix, commercially available as Renuva ® over a 24 months recruitment period.
Study endpoints:
Primary study endpoint will be the completion of 12 months of follow up post injection with safety monitoring. Secondary endpoints will include patient reported outcome measures (VHI, VFI, DI and EAT-10), blinded Cape-V voice assessment by experts and laryngeal videostroboscopy blinded assessment with the mVali tool.
Plan for analysis:
The study cohort will be analyzed via descriptive statistics of the primary outcome (safety) via incidence of both minor and major adverse events. Non-parametric statistics (Wilcoxon signed-rank test) will be used for comparisons of patient reported outcome measures and blinded evaluations of voice and videostroboscopy endpoints from post-intervention time points to pre-intervention baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, prospective, interventional clinical trial
| Arm | Type | Receives |
|---|---|---|
| Injection of Renuva Allograft adipose matrix in vocal fold | Experimental | Biological: Renuva Allograft Adipose MatrixInjection of Renuva Allograft Adipose matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age ≥ 18 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renuva Allograft Adipose MatrixInjection of Renuva Allograft adipose Matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency | Biological | Injection of Renuva Allograft adipose matrix in vocal fold |
Primary outcome
Number of adverse recorded in participants after injection
Time frame: 18 months
Monitoring of adverse events during the study period for each participant receiving a vocal fold injection with Renuva
3 secondary outcomes
Voice outcomes as reported by patient questionnaire
Time frame: 18 months
Score on VALI - Voice Vibratory Assessment of laryngeal imaging
Time frame: 18 months
Dyspnea Index as measured by patient questionnaire
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Derived from this study: PubMed 41195694Santa Maria C, Shuman EA, Bensoussan YE, Bhatt NK, Morgan J, Rodman J, La Forest K, Timmons-Sund L, Johns MM 3rd, O'Dell K. Prospective Short-Term Outcomes of Allograft Adipose Matrix (AAM) for Vocal Fold Augmentation. Laryngoscope. 2026 Apr;136(4):1808-1814. doi: 10.1002/lary.70240. Epub 2025 Nov 6.
- Individual participant dataSharing planned: Undecided
Related trials for Vocal Fold Palsy
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Not yet recruitingPhase 1
Single Dose 4-Aminopyridine for Diagnosing Recurrent Laryngeal Nerve Paralysis Continuity After Trauma
Vocal Cord Paralysis, Recurrent Laryngeal Nerve Palsy
Not yet recruiting
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
Presbylarynx, Aspiration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Renuva Allograft Adipose Matrix in people with Vocal Fold Palsy, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karla O'Dell, MD (18008722273, karla.odell@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse recorded in participants after injection (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700566, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.