Evidence map›Paper›PMID 31804729›Full record

Trial reportThe Laryngoscope2020

Autologous fibroblasts for vocal scars and age-related atrophy: A randomized clinical trial.

Yue Ma, Jennifer Long, Milan R Amin, Ryan C Branski, Edward J Damrose, Chih-Kwang Sung, Stratos Achlatis, Ann Kearney, Dinesh K Chhetri

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Laryngoscope, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Glottic insufficiency caused by vocal fold atrophy with or without sulcus: systematic review of outcome measurements.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Yue MaDepartment of Head and Neck Surgery, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California.ORCID 0000-0002-6176-2549
Jennifer LongDepartment of Head and Neck Surgery, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California.ORCID 0000-0002-4185-2328
Milan R AminDepartment of Otolaryngology-Head and Neck Surgery, New York University Voice Center, New York University School of Medicine, New York, New York.
Ryan C BranskiDepartment of Otolaryngology-Head and Neck Surgery, New York University Voice Center, New York University School of Medicine, New York, New York.
Edward J DamroseDepartment of Otolaryngology-Head and Neck Surgery, Stanford School of Medicine, Stanford University, Stanford, California, U.S.A.ORCID 0000-0003-3983-0805
Chih-Kwang SungDepartment of Otolaryngology-Head and Neck Surgery, Stanford School of Medicine, Stanford University, Stanford, California, U.S.A.ORCID 0000-0001-9795-6452
Stratos AchlatisDepartment of Otolaryngology-Head and Neck Surgery, New York University Voice Center, New York University School of Medicine, New York, New York.
Ann KearneyDepartment of Otolaryngology-Head and Neck Surgery, Stanford School of Medicine, Stanford University, Stanford, California, U.S.A.
Dinesh K ChhetriDepartment of Head and Neck Surgery, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California.
New York University · USStanford Medicine · USUniversity of California, Los Angeles · US

Funding

Neuromuscular control of the LarynxR01DC011300 · NIDCD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CHHETRI, DINESH KHATRI · 2011 to 2021
$6.0M
NIDCD NIH HHS R01 DC011300
6 · The paper itself

Abstract

objectives/hypothesisTo assess the safety and efficacy of autologous cultured fibroblasts (ACFs) to treat dysphonia related to vocal fold scar and age-related vocal atrophy (ARVA). STUDY

designRandomized, double-blinded, placebo-controlled, multi-institutional, phase II trial.

methodsACFs were expanded from punch biopsies of the postauricular skin in each subject; randomization was 2:1 (treatment vs. placebo). Three injections of 1-2 × 10

resultsFifteen subjects received ACF and six received saline injections. At 4, 8, and 12 months after ACF treatments, a significant improvement in mucosal wave grade relative to baseline was observed in both vocal scar and ARVA groups. Relative to control group, mucosal waves were significantly improved in the ARVA group at 4 and 8 months. Perceptual analysis significantly improved in the vocal scar group 12 months after ACF treatments compared to controls. Vocal scar group reported significantly improved vocal quality from baseline. VHI and expert rater voice grade improved in both groups, but did not achieve significance. No adverse events related to fibroblast injections were observed.

conclusionsIn this cohort, injection of ACFs into the vocal fold lamina propria (LP) was safe and significantly improved mucosal waves in patients with vocal scar and ARVA. ACF may hold promise to reconstruct the LP. LEVEL OF EVIDENCE: 1 Laryngoscope, 130:2650-2658, 2020.

Indexed as

AdolescentAdultAgingAtrophyCicatrixDouble-Blind MethodDysphoniaFemaleFibroblastsHumansInjectionsLaryngeal DiseasesMaleMiddle AgedTransplantation, AutologousTreatment Outcomeautologous fibroblastspresbyphoniaRandomized clinical trialvocal foldvocal fold atrophyvocal folds scarvoicevoice quality

Identifiers

PMID31804729
PMCPMC8136686
OpenAlexW2991917739

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.