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

NCT ID: NCT06823908

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2027-10-31

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.

Conditions

Vocal Cord Injuries

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

heathly donors

patients who come as part of their routine care

Reuse of surgical waste

Intervention Type: OTHER

Heathly donnors will be received in the plastic surgery department as part of routine care. They will be informed of the study and their surgical waste (adipose tissue) will be recovered specifically for this research.

CELLCORDES 2 Patient

Patient included in the clinical trial CELLCORDES 2

Reuse of biological samples

Intervention Type: OTHER

Patients included in the cellcordes 2 trial who have given their consent for the re-use of their biological samples (Stromal Vascular Fraction) in other clinical research projects, and who have been informed of the cellcordes bio study.

Interventions

Reuse of surgical waste

Heathly donnors will be received in the plastic surgery department as part of routine care. They will be informed of the study and their surgical waste (adipose tissue) will be recovered specifically for this research.

Intervention Type: OTHER

Reuse of biological samples

Patients included in the cellcordes 2 trial who have given their consent for the re-use of their biological samples (Stromal Vascular Fraction) in other clinical research projects, and who have been informed of the cellcordes bio study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aix Marseille Université

OTHER

Sponsor Role: collaborator

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MATTEI Alexia, Doctor

Role: PRINCIPAL_INVESTIGATOR

assistance publique - hôpitaux de Marseille

Central Contacts

Clement PIERRE, PhD

Role: CONTACT

clement.pierre@ap-hm.fr

+33491435796

Other Identifiers

RCAPHM24_0513

Identifier Type: -

Identifier Source: org_study_id