in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial, called CELLCORDES 2, is looking at a new treatment for people with scarred vocal cords, which can happen due to injury or surgery. The researchers want to see if a special part of fat tissue, known as the stromal vascular fraction, can help reduce scarring and improve voice quality. The study will take place at a single center and is not yet open for recruitment.

To participate, patients must be between 18 and 70 years old, have a significant voice handicap, and have been experiencing vocal cord issues for at least six months after surgery. They should also be in good overall health. Healthy donors, who will provide the fat tissue, are those undergoing liposuction for cosmetic reasons and must meet specific health criteria. If you join the study, you can expect to undergo some evaluations related to your vocal cords and may receive treatment that is being tested. It’s important to note that certain health conditions and situations may exclude individuals from participating, such as being pregnant or having certain infections.

Gender

ALL

Eligibility criteria

• • Inclusion criteria for patients included in the CELLCORDES 2 clinical trial
• • Voice Handicap Index \> 50/120
• • Scarring, congenital (sulcus) or post-phonosurgery vocal cords
• • Vibratory anomalies in the middle third of one or both vocal cords on stroboscopy
• • A minimum of six months after the initial surgery
• • Patients aged 18 to 70 years
• • Good general health
• • Negative pregnancy test and contraception for women of childbearing age Signature of consent for the storage and use of biological samples
• Inclusion criteria for Healthy donnors:
• • Liposuction surgery for aesthetic reasons
• • BMI between 18 and 27
• • No chronic diseases
• • Non-opposition to the use of surgical waste for research purposes after freezing in a biological collection
• Exclusion criteria: For all patients:
• • Refusal or inability to comply with the study procedures
• • Minors
• • Pregnant or breastfeeding women
• • Legally protected adults (under guardianship or curatorship)
• • Individuals residing in a healthcare or social establishment emergency situations
• • Individuals deprived of liberty
• • Detainees
• • Individuals not covered by a social security scheme
• • Use of an experimental drug in the last three months
• • Contraindication to local anesthesia
• • Anticoagulant treatment
• • Coagulation disorders (TP \< 65%, TCA \> 1.2)
• • Premenopausal women of childbearing age without contraception
• • Lack of or refusal of informed consent
• Exclusion criteria for Patients in the CELLCORDES 2 clinical trial:
• • Patients refusing pre- and post-operative speech therapy
• • History of malignant lesions or severe dysplasia on the scarred vocal cord
• • History of laryngeal papillomatosis
• • Active infectious diseases
• • Positive serology for HIV1 and 2, p24 Ag, HCV Abs, HBs Ag, HbC Abs, HTLV and II Abs, TPHA
• • Need for perioperative antibiotic prophylaxi