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

April 8, 2025 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with scared vocal cord

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
heathly donors
patients who come as part of their routine care
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.
CELLCORDES 2 Patient
Patient included in the clinical trial CELLCORDES 2
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months
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.
24 months
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.
24 months
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
collagene protein levels
Time Frame: 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.
24 months
Actine alpha 2 (ACTA2) levels
Time Frame: 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.
24 months
Alpha Smooth muscle actin (aSMA) protein levels
Time Frame: 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
24 months
ollagen type 1 alpha 1 chain (COL1A1) RNA levels
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique Hopitaux De Marseille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aix Marseille Université

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MATTEI Alexia, Doctor, Assistance Publique - Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCAPHM24_0513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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