Vocal Fold ScarsPhase 1NCT05354544
Evaluating Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
A Phase 1 study testing Autologous adipose derived SVF in people with Vocal Fold Scars, run by Shane A. Shapiro at 1 site in United States.
Trial summary
The purpose of this research study is to assess if autologous Stromal Vascular Fraction (SVF) taken from the stomach or hips can help heal vocal fold scars. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vocal Fold Scars
- What is being tested?
- Autologous adipose derived SVF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 5 Dec 2024
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Safety and Feasibility of Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
The purpose of this research study is to assess if autologous Stromal Vascular Fraction (SVF) taken from the stomach or hips can help heal vocal fold scars.
- Conditions
- Vocal Fold Scars
- Being tested
- Autologous adipose derived SVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose derived SVFBiological
A single dose of autologous adipose derived SVF isolated from adipose tissue will be administered to scarred vocal folds.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Autologous adipose derived SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
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
Measured: Baseline, Week 1, and Months 1, 3, 6, 9, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Aug 2021
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Why it stopped: Funding loss
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold ScarsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shane A. Shapiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shane A. Shapiro, Mayo Clinic
- Investigators
- Amy Rutt, DO, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354544
- Sponsor's protocol ID
- 19-006564
- Status last verified
- Jun 2024
- First submitted
- 26 Apr 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Safety and Feasibility of Autologous Stromal Vascular Fraction in Subjects with Vocal Fold Scar
- ClinicalTrials.gov ID
- NCT05354544
- Acronym / sponsor ID
- 19-006564
- Conditions
- Vocal Fold Scars
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding loss
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shane A. ShapiroUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 29 Apr 2022 (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.
The purpose of this research study is to assess if autologous Stromal Vascular Fraction (SVF) taken from the stomach or hips can help heal vocal fold scars.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SVF for treating scarred vocal folds | Experimental | Biological: Autologous adipose derived SVFSubject identified with scarred vocal folds will have autologous adipose derived SVF harvested and applied to scarred vocal folds. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Autologous adipose derived SVFA single dose of autologous adipose derived SVF isolated from adipose tissue will be administered to scarred vocal folds. | Biological | SVF for treating scarred vocal folds |
Primary outcome
Adverse events post SVF administration
Time frame: 24 months
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.
1 secondary outcome
Voice handicap Index
Time frame: Baseline, Week 1, and Months 1, 3, 6, 9, 12, and 24
Results and safety
The study was stopped early (reason given: Funding loss). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Amy Rutt, DO principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous adipose derived SVF in people with Vocal Fold Scars, run by Shane A. Shapiro 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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 19 Dec 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding loss). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events post SVF administration (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.