Injection Laryngoplasty Using Autologous Fat Enriched with Adipose-Derived Regenerative Stem Cells: A Safe Therapeutic Option for the Functional Reconstruction of the Glottal Gap after Unilateral Vocal Fold Paralysis

José M Lasso, Daniel Poletti, Batolomé Scola, Pedro Gómez-Vilda, Ana I García-Martín, María Eugenia Fernández-Santos, José M Lasso, Daniel Poletti, Batolomé Scola, Pedro Gómez-Vilda, Ana I García-Martín, María Eugenia Fernández-Santos

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.

Figures

Figure 1
Figure 1
Endoscopic captures of the vocal folds in the patient FS4 (group I) before, during, and after injection (pictures captured from endoscopic video).
Figure 2
Figure 2
(a) Web plot of the longitudinal study. The evolution of the 14 parameters selected is shown chronologically from red (pre) to dark blue (post). Each normalized feature must be read on the intersection of each polygon with the corresponding feature radius. Clearly, features 2, 3, 35, 38, 40, 44, 46, and 60 are beyond the normality limits. (b) Manhattan skyline of the same study. Each feature from the four session recordings is presented chronologically from red to dark blue. The different features are now presented as polyhedral columns, the height of the column giving the normalized value of the feature relative to the population mean.
Figure 3
Figure 3
Evolution of the satisfaction scores for groups I (FS and MS) and II (FF and MF).

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