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Stem Cell Therapy

Autologous SVF for Vocal Fold Scarring

Phase 1
Recruiting
Led By Amy Rutt, DO
Research Sponsored by Shane A. Shapiro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject's age between 18 and < 80-years-old
Unilateral or Bilateral vocal fold scarring
Must not have
Refusal or inability to comply with study procedures
Refusal of speech therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, and months 1, 3, 6, 9, 12, and 24
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether fat from a patient's stomach or hips can be used to heal vocal cord scars.

Who is the study for?
This trial is for adults aged 18-65 with vocal fold scarring, either from surgery or congenital causes. Participants must have had the scar for at least a year and experience significant voice handicap. Women of childbearing age should test negative for pregnancy and use contraception. Those with anesthesia risks, bleeding disorders, active infections, recent cancer treatments, COPD, kidney disease, stroke history or severe heart issues can't join.
What is being tested?
The study tests if SVF cells taken from a person's own fat tissue can repair damaged vocal cords. The SVF is harvested from the patient's stomach or hips under anesthesia to see if it improves their voice quality by healing the scars on their vocal folds.
What are the potential side effects?
Potential side effects may include reactions to anesthesia, discomfort at the extraction site (stomach/hips), infection risk increase due to invasive procedures involved in harvesting and injecting SVF cells into the vocal folds.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 79 years old.
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I have scarring on one or both of my vocal cords.
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My vocal cords are scarred or I've had surgery on them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable or unwilling to follow the study's procedures.
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I have chosen not to undergo speech therapy.
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I have had cancer or severe cell changes in my scarred vocal cord.
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I do not have issues with anesthesia, bleeding disorders, or active infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, and months 1, 3, 6, 9, 12, and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, and months 1, 3, 6, 9, 12, and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events post SVF administration
Secondary study objectives
Voice handicap Index

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SVF for treating scarred vocal foldsExperimental Treatment1 Intervention
Subject identified with scarred vocal folds will have autologous adipose derived SVF harvested and applied to scarred vocal folds.

Find a Location

Who is running the clinical trial?

Shane A. ShapiroLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Amy Rutt, DOPrincipal InvestigatorMayo Clinic

Media Library

Autologous adipose derived SVF (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05354544 — Phase 1
Vocal Fold Scarring Research Study Groups: SVF for treating scarred vocal folds
Vocal Fold Scarring Clinical Trial 2023: Autologous adipose derived SVF Highlights & Side Effects. Trial Name: NCT05354544 — Phase 1
Autologous adipose derived SVF (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05354544 — Phase 1
~1 spots leftby May 2025
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