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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

Conditions: Vocal Cord Injuries

Treatments: Other: Reuse of surgical waste; Other: Reuse of biological samples

Study type: Observational

Funder types: Other

Identifiers

NCT06823908

RCAPHM24_0513

Details and patient eligibility

About

This is a single-center, prospective study, aimed at investigating the anti-fibrotic in vitro activity of the stromal vascular fraction of patients with scarred vocal cord.

Full description

This single-center, prospective study will last 28 months and will be carried out in two stages:

1. Comparison of the in vitro anti-fibrotic activity and production/management circuit of different cell therapy products derived from adipose tissue obtained from healthy donors (n=8) [secondary objective] during the first 12 months of the project.
2. Evaluate the association between the in vitro anti-fibrotic activity of fraction vascular fraction (FVS) samples and the clinical improvement obtained with the same sample autologously injected into a patient in the CELLCORDES2 trial (minimum recruitment n=10, CELLCORDES2 biocollection) [primary objective]. This second stage will be carried out between M12 and M24 to optimize the number of patients to be included.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

18 participants in 2 patient groups

heathly donors

Description:

patients who come as part of their routine care

Treatment:

Other: Reuse of surgical waste

CELLCORDES 2 Patient

Description:

Patient included in the clinical trial CELLCORDES 2

Treatment:

Other: Reuse of biological samples