Vocal Cord InjuriesCELLCORDES BIONCT06823908
in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds
An observational study of Vocal Cord Injuries, run by Assistance Publique Hopitaux De Marseille.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vocal Cord Injuries
- What is being tested?
- Reuse of surgical waste and Reuse of biological samples
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with scared vocal cord
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
This single-center, prospective study will last 28 months and will be carried out in two stages:
- 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.
- 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
- Being tested
- Reuse of surgical waste, Reuse of biological samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reuse of surgical wasteOther
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.
Reuse of biological samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| heathly donors | patients who come as part of their routine care Receives: Other: Reuse of surgical waste | |
| CELLCORDES 2 Patient | Patient included in the clinical trial CELLCORDES 2 Receives: Other: Reuse of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (4)
collagene protein levels
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.
Measured: 24 months
Actine alpha 2 (ACTA2) levels
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.
Measured: 24 months
Alpha Smooth muscle actin (aSMA) protein levels
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
Measured: 24 months
ollagen type 1 alpha 1 chain (COL1A1) RNA levels
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université
- Responsible party
- Sponsor
- Investigators
- MATTEI Alexia, Doctor, Principal investigator, assistance publique - hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823908
- Sponsor's protocol ID
- RCAPHM24_0513
- Acronym
- CELLCORDES BIO
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06823908
- Acronym / sponsor ID
- CELLCORDES BIO / RCAPHM24_0513
- Conditions
- Vocal Cord Injuries
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- Aix Marseille Université
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heathly donors | – | Other: Reuse of surgical wastepatients who come as part of their routine care |
| CELLCORDES 2 Patient | – | Other: Reuse of biological samplesPatient included in the clinical trial CELLCORDES 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with scared vocal cord
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reuse of surgical wasteHeathly 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 | heathly donors |
| Reuse of biological samplesPatients 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. | Other | CELLCORDES 2 Patient |
Primary outcome
collagene protein levels
Time frame: 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
Time frame: 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
Time frame: 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.
collagen type 1 alpha 1 chain (COL1A1) RNA levels
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MATTEI Alexia, Doctor principal investigator
assistance publique - hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Cord Injuries, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clement PIERRE, PhD (+33491435796, clement.pierre@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collagene protein levels (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.