UVFPUnilateral Vocal Fold Paralysis
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On the other hand, large prospective clinical trials have not been reported about the use of ADRC-enriched fat grafting for patients presenting GG after UVFP. As such, the aim of this study is to propose the use of ADRC-enriched adipose tissue grafts as effective filler for the paralyzed vocal fold in order to use it as a novel therapeutic option for the functional reconstruction of the GG.
The present study corresponds to the first phase I-IIA clinical trial (phase I/IIA clinical trial, unicentric, randomized, controlled, and two parallel groups), to evaluate the safety of a new therapy with ADRC-enriched fat grafting (AF + ADRCs) for VF laryngoplasty after UVFP originating a GG in the International Conference on Harmonization (ICH) E2F format.
Female and male patients (older than 18 years) presenting GG after UVFP were eligible for enrollment.
Surgery of UVFP consists basically in two techniques: open surgery on the laryngeal box and injection laryngoplasty with autologous or nonautologous materials [2].
In this work, we wanted to evaluate the safety and use of autologous ADRCs for increasing the volume in UVFP leading to GG insufficiency.