Treatment for scarred vocal folds using fat-derived cells
INNOVATIVE TREATMENT OF SCARRED VOCAL FOLDS BY LOCAL INJECTION OF AUTOLOGOUS ADIPOSE-DERIVED STROMAL VASCULAR FRACTION: EFFICACY VERSUS PLACEBO
This study is testing whether injections of fat-derived cells can help people with scarred vocal folds improve their voice compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille, Paca) |
| Trial ID | NCT05385159 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of autologous adipose-derived stromal vascular fraction (ADSVF) injections for treating scarred vocal folds, which can lead to significant voice impairment. The study compares the effects of ADSVF against a placebo in patients suffering from vocal fold scarring due to congenital issues or previous surgeries. By utilizing the regenerative properties of ADSVF, the trial aims to improve the vibrational mechanical properties of the vocal folds, addressing a critical clinical challenge in voice therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a voice handicap index greater than 50 and diagnosed with scarred vocal folds.
Not a fit: Patients with a history of malignant lesions, severe dysplasia, or contraindications to local anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve voice quality and reduce disability for individuals with scarred vocal folds.
How similar studies have performed: While there have been promising reports on the use of ADSVF in other contexts, this specific application for vocal fold scarring is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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.
Where this trial is running
Marseille, Paca
- Assistance Publique Hopitaux de Marseille — Marseille, Paca, France (Recruiting)
Study contacts
- Study coordinator: Antoine GIOVANNI, Pr
- Email: antoine.giovanni@ap-hm.fr
- Phone: 04 91 33 58 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.