in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reuse of surgical waste, Reuse of biological samples.
- Who it may be relevant to
- Registry conditions: Vocal Cord Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Other 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. - 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.
Primary outcome measures
- collagene protein levels [Time frame: 24 months]
- Actine alpha 2 (ACTA2) RNA levels [Time frame: 24 months]
- Alpha Smooth muscle actin (aSMA) protein levels [Time frame: 24 months]
- collagen type 1 alpha 1 chain (COL1A1) RNA levels [Time frame: 24 months]
Secondary outcome measures (4)
- collagene protein levels [Time frame: 24 months]
- Actine alpha 2 (ACTA2) levels [Time frame: 24 months]
- Alpha Smooth muscle actin (aSMA) protein levels [Time frame: 24 months]
- ollagen type 1 alpha 1 chain (COL1A1) RNA levels [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06823908 · RCAPHM24_0513