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

Not yet recruiting

• Conditions: Vocal Cord Injuries

• Registration Number: NCT06823908
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-12
• Status Verified: 2025-04
• Study Start: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2027-04
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.