AUTOLOGOUS ADIPOSE TISSUE-DERIVED STROMAL VASCULAR FRACTION CELLS for Scarred vocal folds

Inclusion criteria

• {"criterion_text":"- Subscription to the French Social Security System\n- Voice Handicap Index > 50/120\n- Scarred vocal folds, congenital (sulcus) or after phonosurgery\n- Scarred middle third in videolaryngostroboscopy\n- At least six-months delay after initial surgery if appropriate\n- Patients aged between 18 and 70\n- Good general condition\n- Negative pregnancy test & contraception for women of child-bearing age"}

Exclusion criteria

• {"criterion_text":"- Refusal of speech therapy\n- BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest\n- History of malignant lesion or severe dysplasia of the scarred vocal fold\n- History of laryngeal papillomatosis\n- Contre-indication à l'anesthésie locale\n- Anti-coagulant treatment\n- Coagulation disorders (Prothrombin Ratio <65%, Activated Partial Thromboplastin Time >1,2)\n- Active infectious diseases\n- Any active viral infection from among the following: HIV, HTLV I and II, VHB, VHC and Syphilis\n- Known sensitivity to human serum albumin (HSA)"}

Primary endpoints

• {"endpoint_text":"- Changes from baseline in Self-evaluation with the Voice Handicap Index (VHI), a shift in the total score of 18 points or greater being required to be clinically significant (Jacobson, 1997)","definition_or_measurement_approach":"Self-evaluation using the Voice Handicap Index (VHI); clinically significant improvement defined as a shift in total score of ≥18 points (Jacobson, 1997); primary assessment at 6 months post treatment."}

Secondary endpoints

• {"endpoint_text":"- VHI at 1 month\n- self-evaluation of dysphonia (0-10 scale)\n- voice acoustic measurements\n- voice aerodynamic measurements: maximum phonation time\n- perceptive analysis (GRB scale): score will be calculated by addition of two characteristics\n- videolaryngostroboscopy\n- The incidence of related Adverse Events","definition_or_measurement_approach":"VHI at 1 month: measured by the Voice Handicap Index instrument at 1 month; self-evaluation of dysphonia: patient-rated 0-10 scale; voice acoustic measurements: objective acoustic analyses; voice aerodynamic measurements: maximum phonation time; perceptive analysis: GRB scale scoring as described; videolaryngostroboscopy: stroboscopic assessment; safety: incidence of related adverse events."}

France

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

542

Number Of Sites

2

Number Of Participants

36

Primary sponsor

Full Name

Centre Hospitalier Regional De Marseille

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France