Last updated: September 14, 2023
Sponsor: Assistance Publique Hopitaux De Marseille
Overall Status: Active - Recruiting
Phase
2
Condition
Scar Tissue
Treatment
AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION
Placebo
Clinical Study ID
NCT05385159
2020-53
2020-004227-17
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 andSyphilis;
- known sensitivity to human serum albumin (HSA);
- necessity of intraoperative prophylactic antibiotics;
- BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissueaccessible to lipoharvest.
Study Design
Total Participants: 36
Treatment Group(s): 2
Primary Treatment: AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION
Phase: 2
Study Start date:
September 22, 2022
Estimated Completion Date:
June 30, 2025
Connect with a study center
Assistance Publique Hopitaux de Marseille
Marseille, Paca 13354
FranceActive - Recruiting
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