Vocal Cord Injuries
Conditions
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.
Interventions
OTHERReuse 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.
OTHERReuse 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.
Sponsors
Aix Marseille Université
Assistance Publique Hopitaux De Marseille
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| collagen type 1 alpha 1 chain (COL1A1) RNA levels | 24 months | 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. |
| collagene protein levels | 24 months | 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. |
| Actine alpha 2 (ACTA2) RNA levels | 24 months | 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. |
| Alpha Smooth muscle actin (aSMA) protein levels | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| collagene protein levels | 24 months | Cellular products obtained from adipose tissue obtained from healthy donnors will be co-cultured with an in-vitro model of scarred vocal cord. Then, the levels of collagen will be quantified by western blot to measure the anti-fibrotic activity of different cellular products. |
| Actine alpha 2 (ACTA2) levels | 24 months | Cellular products obtained from adipose tissue of healthy donnors 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 different cellular products. |
| Alpha Smooth muscle actin (aSMA) protein levels | 24 months | Cellular products obtained from adipose tissue of healthy donnors will be co-cultured with an in-vitro model of scarred vocal cord. Then, the RNA levels of aSMA will be quantified by western blot to measure the anti-fibrotic activity of different cellular products |
| ollagen type 1 alpha 1 chain (COL1A1) RNA levels | 24 months | Cellular products obtained from adipose tissue of healthy donnors will be co-cultured with an in-vitro model of scarred vocal cord. Then, the RNA levels of COL1A1 will be quantified by RT-qPCR to measure the anti-fibrotic activity of different cellular products. |
Contacts
Primary ContactClement PIERRE, PhD
Outcome results
None listed