Study on the Effectiveness of Autologous Adipose-Derived Stromal Vascular Fraction Cells for Patients with Scarred Vocal Folds

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What is this study about?

This clinical trial is focused on the treatment of scarred vocal cords, a condition that can affect the voice, making it difficult to speak clearly. The study is testing a new treatment using autologous adipose tissue-derived stromal vascular fraction cells. These are special cells taken from a person’s own fat tissue, which are then injected into the vocal cords. The aim is to see if this treatment can improve the voice by reducing the scarring.

Participants in the study will receive either the new cell treatment or a placebo, which is a solution containing sodium chloride and human serum albumin but no active cells. The purpose of the study is to compare the effectiveness of the cell treatment against the placebo in improving voice quality. This will be measured using a tool called the Voice Handicap Index, which helps assess how much the voice problem affects daily life. The study will look for improvements in voice quality six months after the treatment.

Throughout the study, participants will undergo various assessments to monitor changes in their voice. These assessments include self-evaluations, voice measurements, and video examinations of the vocal cords. The study will also track any side effects that may occur. The goal is to determine if the new treatment can provide a significant improvement in voice quality for those with scarred vocal cords.

1 initial assessment

An initial assessment is conducted to confirm eligibility for the trial. This includes verifying that the Voice Handicap Index is greater than 50 out of 120, and that the vocal folds are scarred, either congenitally or post-surgery.

A videolaryngostroboscopy is performed to confirm scarring in the middle third of the vocal folds. A negative pregnancy test is required for women of child-bearing age, along with the use of contraception.

2 treatment administration

The treatment involves a local injection into the vocal folds. There are two types of injections: one with autologous adipose-derived stromal vascular fraction cells and another with a placebo consisting of saline solution and human serum albumin.

The injection is prepared as a suspension for injection and administered locally to the affected area.

3 follow-up evaluations

Follow-up evaluations are conducted to assess the efficacy of the treatment. The primary measure is the change in the Voice Handicap Index, with a significant improvement defined as a change of 18 points or more.

Secondary evaluations include self-assessment of dysphonia on a scale from 0 to 10, voice acoustic and aerodynamic measurements, perceptive analysis using the GRB scale, and videolaryngostroboscopy.

4 monitoring for adverse events

Throughout the trial, monitoring for any adverse events related to the treatment is conducted. This ensures the safety and well-being of the participant.

5 final assessment

A final assessment is conducted six months after the treatment to evaluate the long-term efficacy of the injection. This includes a comprehensive review of all primary and secondary endpoints.

Who Can Join the Study?

Must be subscribed to the French Social Security System.
Have a Voice Handicap Index score greater than 50 out of 120. This is a way to measure how much your voice problem affects your daily life.
Have scarred vocal folds, which can be from birth (called sulcus) or after surgery on the voice box (phonosurgery).
Have scarring in the middle part of the vocal folds, as seen in a special examination called videolaryngostroboscopy. This is a test that uses a camera to look at your vocal cords while you speak.
If you had surgery before, it must be at least six months ago.
Be between 18 and 70 years old.
Be in good general health.
If you are a woman who can have children, you must have a negative pregnancy test and use contraception.

Who Cannot Join the Study?

Patients with scarred vocal folds cannot participate. This means if your vocal cords have been damaged and have scar tissue, you are not eligible.
Individuals who are not within the specified age range cannot participate. The trial is open to certain age groups only.
Both male and female participants are allowed, but if you do not identify as either, you may not be eligible.
Participants who are considered part of a vulnerable population are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Ansmsqixig Ppxqnrsb Hcwbdafp Dj Mwlgfmqxe	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	22.09.2022

Trial locations

Investigated drugs:

Autologous Adipose-Derived Stromal Vascular Fraction is a treatment that involves using a patient’s own fat tissue to extract a special mixture of cells. This mixture is then injected into the scarred vocal cords. The goal is to help improve the voice by reducing the effects of scarring on the vocal cords. This treatment is being tested to see if it can make a significant improvement in voice quality for people with this condition.

Scarred Vocal Folds – This condition occurs when the vocal cords, located in the larynx, develop scar tissue. The scarring can result from surgery, injury, or prolonged vocal strain. As the scar tissue forms, it can stiffen the vocal folds, affecting their ability to vibrate properly. This leads to changes in voice quality, often causing hoarseness or a raspy voice. Over time, individuals may experience difficulty in speaking or a reduced vocal range. The progression of the condition can vary, with some people experiencing more significant voice changes than others.

Trial ID:

2024-517384-24-00

Protocol code:

cellcordes2

NCT ID:

NCT05385159

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Autologous Adipose-Derived Stromal Vascular Fraction Cells for Patients with Scarred Vocal Folds

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?