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

NCT06823908 | Not Yet Recruiting

• 1 other identifier: RCAPHM24_0513
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vocal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• collagene protein levels

  The stromal vascular fraction of patient will be co-cultured with an in-vitro model of scarred vocal cord. Then, the levels of collagene will be quantified by western blot to measure the anti-fibrotic activity of SVF.

  24 months

• Actine alpha 2 (ACTA2) RNA levels

  The stromal vascular fraction of patient will be co-cultured with an in-vitro model of scarred vocal cord. Then, the levels of ACTA2 will be quantified by RT-qPCR to measure the anti-fibrotic activity of SVF.

  24 months

• Alpha Smooth muscle actin (aSMA) protein levels

  The stromal vascular fraction of patient will be co-cultured with an in-vitro model of scarred vocal cord. Then, the levels of aSMA will be quantified by western blot to measure the anti-fibrotic activity of SVF.

  24 months

• collagen type 1 alpha 1 chain (COL1A1) RNA levels

  The stromal vascular fraction of patient will be co-cultured with an in-vitro model of scarred vocal cord. Then, the levels of COL1A1will be quantified by RT-qPCR to measure the anti-fibrotic activity of SVF.

  24 months

Secondary Outcomes (4)

• collagene protein levels

  24 months

• Actine alpha 2 (ACTA2) levels

  24 months

• Alpha Smooth muscle actin (aSMA) protein levels

  24 months

• ollagen type 1 alpha 1 chain (COL1A1) RNA levels

  24 months

Study Arms (2)

heathly donors

patients who come as part of their routine care

Other: Reuse of surgical waste

CELLCORDES 2 Patient

Patient included in the clinical trial CELLCORDES 2

Other: Reuse of biological samples

Interventions

Reuse of surgical waste 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.

heathly donors

Reuse of biological samples 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.

CELLCORDES 2 Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with scared vocal cord

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead
• Aix Marseille Université: collaborator

Study Officials

• MATTEI Alexia, Doctor

  assistance publique - hôpitaux de Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clement PIERRE, PhD

CONTACT

+33491435796; clement.pierre@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04