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INNOVATIVE TREATMENT OF SCARRED VOCAL FOLDS BY LOCAL INJECTION OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION: EFFICACY VERSUS PLACEBO
EU CTIS ID: 2024-517384-24-00
What this study is testing
Evaluate and compare the efficacy of fresh autologous adipose-derived stromal vascular fraction injection, in comparison with a placebo (saline solution and human serum albumin, vehicle of SVF without cells), on dysphonia linked to scarred vocal cords, based on a self-assessment via the Voice Handicap Index (significant improvement if ≥ 18 points according to Jacobson) at 6 months post treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subscription to the French Social Security System
- Voice Handicap Index > 50/120
- Scarred vocal folds, congenital (sulcus) or after phonosurgery
- Scarred middle third in videolaryngostroboscopy
- At least six-months delay after initial surgery if appropriate
- Patients aged between 18 and 70
You likely can't join if
- Refusal of speech therapy
- BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest
- History of malignant lesion or severe dysplasia of the scarred vocal fold
- History of laryngeal papillomatosis
- Contre-indication à l'anesthésie locale
- Anti-coagulant treatment
See the full eligibility criteria
- Subscription to the French Social Security System
- Voice Handicap Index > 50/120
- Scarred vocal folds, congenital (sulcus) or after phonosurgery
- Scarred middle third in videolaryngostroboscopy
- At least six-months delay after initial surgery if appropriate
- Patients aged between 18 and 70
- Good general condition
- Negative pregnancy test & contraception for women of child-bearing age
- Refusal of speech therapy
- BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest
- History of malignant lesion or severe dysplasia of the scarred vocal fold
- History of laryngeal papillomatosis
- Contre-indication à l'anesthésie locale
- Anti-coagulant treatment
- Coagulation disorders (Prothrombin Ratio <65%, Activated Partial Thromboplastin Time >1,2)
- Active infectious diseases
- Any active viral infection from among the following: HIV, HTLV I and II, VHB, VHC and Syphilis
- Known sensitivity to human serum albumin (HSA)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.