Status:
UNKNOWN
INNOVATIVE TREATMENT OF SCARRED VOCAL FOLDS BY LOCAL INJECTION OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION: EFFICACY VERSUS PLACEBO
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Scarred Vocal Folds
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Vocal Folds scarring (whether congenitally or following phonosurgery) can result in a range of symptoms depending on severity and extent, such as hoarseness, breathy voice, increased effort to speak, ...
Eligibility Criteria
Inclusion
- Subscription to the French Social Security System
- signed informed consent;
- voice Handicap Index \> 50/120;
- scarred vocal folds, congenital (sulcus) or after phonosurgery;
- scarred middle third in videolaryngostroboscopy;
- at least six-months delay after initial surgery if appropriate;
- patients aged between 18 and 70;
- good general condition;
- negative pregnancy test \& contraception for women of child-bearing age.
Exclusion
- Refusal of speech therapy;
- history of malignant lesion or severe dysplasia of the scarred vocal fold;
- history of laryngeal papillomatosis;
- contraindication to local anesthesia;
- anti-coagulant treatment;
- coagulation disorders (Prothrombin Ratio \<65%, Activated Partial Thromboplastin Time \>1,2);
- active infectious diseases;
- any active viral infection from among the following: HIV, HTLV I and II, VHB, VHC and Syphilis;
- known sensitivity to human serum albumin (HSA);
- necessity of intraoperative prophylactic antibiotics;
- BMI \< 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest.
Key Trial Info
Start Date :
September 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05385159
Start Date
September 22 2022
End Date
June 1 2025
Last Update
September 18 2023
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, PACA, France, 13354