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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.

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.

SUBMITTER: Lasso JM

PROVIDER: S-EPMC5924970 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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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.

Lasso José M JM Poletti Daniel D Scola Batolomé B Gómez-Vilda Pedro P García-Martín Ana I AI Fernández-Santos María Eugenia ME

Stem cells international 20180415

<h4>Background</h4>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 tissu ...[more]

PMID: 29760737

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Project description:BackgroundWhile injection laryngoplasty is becoming increasingly common in children, there has not been clearly established guidelines for the choice of injection material. This study evaluates for variability in post-surgical outcomes between different materials used for injection laryngoplasty in the treatment of pediatric unilateral vocal cord paralysis.MethodsIn this cohort study, a retrospective chart review was performed for all patients undergoing injection laryngoplasty for unilateral vocal cord paralysis at our tertiary-care children's hospital between January 2010 and December 2019. Patients with vocal cord paresis or bilateral vocal cord paralysis were excluded from this study. Demographics, pre- and post-injection clinic visits, and operative reports were reviewed to compare outcomes between injection materials, including the number of injections required, inter-surgical interval, and rate of vocal improvement.ResultsForty-four patients were included in the analysis. Half of the patients were female, and half were male. A total of 97 injections were observed, with 32 patients receiving multiple injections. The mean age at first injection was 7 years. The most common causes of vocal fold paralysis were iatrogenic (n=21, 48%) and idiopathic (n=9, 20%). Thirty-nine percent (n=17) had a history of cardiac surgery. Forty-five percent of injections used Radiesse® voice/Prolaryn® plus, 35% used Radiesse®/Prolaryn® voice Gel, and 20% used Cymetra™. The material used was not associated with a difference in post-operative outcomes, including number of injections, (P=0.10; 0.29), inter-surgical interval (P=0.27; 0.29), or rate of voice improvement (P=0.86; 0.36).ConclusionsNeither material choice nor demographic factors were associated with a difference in outcomes following injection laryngoplasty or a change in the inter-surgical interval. Further research is needed to develop standardized protocols for injection laryngoplasty in this population.

Project description:ImportanceUnilateral vocal fold paralysis (UVFP) is a common and life-changing complication of cancer, trauma, and an estimated 500 000 head, neck, and chest surgeries performed annually in the US, among other causes (eg, idiopathic). Consequent disabilities are profound and often permanent and can include severe voice, swallowing, and breathing dysfunction and concomitant anxiety, isolation, and fear. Physiological measures often correlate poorly with patient-reported disability. The measure described herein was designed to be a comprehensive, psychometrically sound UVFP-specific patient-reported outcome measure (PROM) for use in clinical trials or at point of care.ObjectiveTo evaluate the reliability and validity of the CoPE (vocal Cord Paralysis Experience) PROM in a nationally representative sample for both clinical and research use.Design, setting, and participantsThis survey validation study was performed at 34 tertiary care centers across the US and included English-speaking adults with unilateral vocal fold immobility confirmed via laryngoscopy.Main outcomes and measuresReliability (internal consistency, alternate form, and test-retest) and validity (convergent and known-group).ResultsIn total, 613 patients (mean [SD] age, 58 [15.3] years; 394 [64.5%] women) were recruited, and 555 (92.3%) completed surveys for all time points. Internal consistency was high in the overall 22-item PROM and psychosocial, swallow, and voice subscales (Cronbach α > 0.91). Intraclass correlations for individuals between the baseline and 2-week administrations were moderate for the overall score and subscales (intraclass correlations range, 0.66-0.80). There were significant differences between the online and 2-week paper administrations for the overall score and voice and psychosocial subscales (overall scale mean: 54.4 [95% CI, 49.7-59.1] vs 48.9 [95% CI, 43.7-54.0] at 2 weeks). The confirmatory model was found to be suitably fitted based on average r2 values 0.5 or greater for subscale and overall scores. Correlations between subscales and existing PROMs (Voice-Related Quality of Life, Eating Assessment Tool, and Communication Participation Item Bank) were all greater than 0.69, and mean PROM subscale scores were significantly different across known quartiles of existing PROMs.Conclusions and relevanceThe findings of this survey validation study suggest that the CoPE PROM could serve as a psychometrically sound, comprehensive measure of UVFP-attributed disability suitable for use in clinical and research settings to assess within-person changes. The results will inform a user manual to facilitate use in clinical trials comparing the effectiveness and durability of treatments including behavioral (speech therapy), temporary (eg, injection augmentation), and permanent surgical treatments for UVFP.

Dataset Information

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.

Publications

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.

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