Abstract
Background Paralysis of one vocal fold leads to glottal gap and vocal fold insufficiency that has significant impact upon a patient's quality of life. Fillers have been tested to perform intracordal injections, but they do not provide perdurable results. Early data suggest that enriching fat grafts with adipose-derived regenerative cells (ADRCs) promote angiogenesis and modulate the immune response, improving graft survival. The aim of this study is to propose ADRC-enriched adipose tissue grafts as effective filler for the paralyzed vocal fold to use it for functional reconstruction of the glottal gap. Method This is 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 (ADRC: group I) for laryngoplasty after unilateral vocal fold paralysis. Control group patients received centrifuged autologous fat (CAF: group II) grafts. Overall mean age is 52.49 ± 16.60 years. Group I (ADRC): 7 patients (3 males and 4 females), 52.28 ± 20.95 year. Group II (CAF): 7 patients (3 males and 4 females), 52.71 ± 12.59 year. Results VHI-10 test showed that preoperative mean score was 24.21 ± 8.28. Postoperative mean score was 6.71 ± 6.75. Preoperative result in group I was 21.14 ± 3.58 and postoperative result was 3.14 ± 3.53. Preoperative result for group II was 27.29 ± 10.66. Postoperative score in group II was 10.29 ± 7.52. Wilcoxon and the Student t-tests showed that the patient's self-perception of posttreatment improvement is larger when ADRCs are used. Comparing pre- and posttreatment voice quality analysis, group I showed a p = 0.053. Group II showed a p = 0.007. There would be no significant differentiation between pre- and posttreatment results. This is true for group II and limited for group I. Conclusions This prospective trial demonstrates the safety and efficacy of the treatment of glottal gap defects utilizing ADRC-enriched fat grafts. This trial is registered with NCT02904824.
Highlights
Paralysis of one of the vocal folds (VF) may have a significant impact upon a patient’s quality of life
The aim of this study is to propose the use of ADRC-enriched fat grafting (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 glottal gap (GG)
The present study corresponds to the first phase I-IIA clinical trial, to evaluate the safety of a new therapy with ADRC-enriched fat grafting (AF + ADRCs) for VF laryngoplasty after Unilateral vocal fold paralysis (UVFP) originating a GG in the International Conference on Harmonization (ICH) E2F format
Summary
Paralysis of one of the vocal folds (VF) may have a significant impact upon a patient’s quality of life. Unilateral vocal fold paralysis (UVFP) is one of the main causes of glottal gap (GG) and VF insufficiency. Paralysis of one vocal fold leads to glottal gap and vocal fold insufficiency that has significant impact upon a patient’s quality of life. This is 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 (ADRC: group I) for laryngoplasty after unilateral vocal fold paralysis. This prospective trial demonstrates the safety and efficacy of the treatment of glottal gap defects utilizing ADRC-enriched fat grafts.
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