Clinical trial NCT06823908: in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds
Official title: in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds: Interest in the Definition of 'Potency' Markers and Optimized Cellular Engineering Trategies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vocal Cord Injuries
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
Collaborators: name: Aix Marseille Université
First posted: 2025-02-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with scared vocal cord

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: collagene protein levels
timeFrame: 24 months
measure: Actine alpha 2 (ACTA2) RNA levels
timeFrame: 24 months
measure: Alpha Smooth muscle actin (aSMA) protein levels
timeFrame: 24 months
measure: collagen type 1 alpha 1 chain (COL1A1) RNA levels
timeFrame: 24 months
Secondary outcomes:
measure: collagene protein levels
timeFrame: 24 months
measure: Actine alpha 2 (ACTA2) levels
timeFrame: 24 months
measure: Alpha Smooth muscle actin (aSMA) protein levels
timeFrame: 24 months
measure: ollagen type 1 alpha 1 chain (COL1A1) RNA levels
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: assistance publique - hôpitaux de Marseille
name: MATTEI Alexia, Doctor
role: PRINCIPAL_INVESTIGATOR
References: