Evidence map›Paper›PMID 33988246›Full record

ArticleThe Laryngoscope2022

Autologous Muscle-Derived Cell Therapy for Swallowing Impairment in Patients Following Treatment for Head and Neck Cancer.

Nogah Nativ-Zeltzer, Maggie A Kuhn, Lisa Evangelista, Johnathon D Anderson, Jan A Nolta, D Gregory Farwell, Emanuele Canestrari, Ron J Jankowski, Peter C Belafsky

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in The Laryngoscope, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Progress on cell therapy for skeletal muscle disorders.Advanced drug delivery reviews · 2026
    Review
  3. Review
  4. Article
  5. Article
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.

Nogah Nativ-ZeltzerDepartment of Otolaryngology-Head and Neck Surgery, University of California, Davis Medical Center, Sacramento, California, U.S.A.
Maggie A KuhnDepartment of Otolaryngology-Head and Neck Surgery, University of California, Davis Medical Center, Sacramento, California, U.S.A.
Lisa EvangelistaDepartment of Otolaryngology-Head and Neck Surgery, University of California, Davis Medical Center, Sacramento, California, U.S.A.
Johnathon D AndersonDepartment of Otolaryngology-Head and Neck Surgery, University of California, Davis Medical Center, Sacramento, California, U.S.A.
Jan A NoltaInstitute for Regenerative Cures, Department of Internal Medicine, University of California, Davis, Sacramento, California, U.S.A.
D Gregory FarwellDepartment of Otolaryngology-Head and Neck Surgery, University of California, Davis Medical Center, Sacramento, California, U.S.A.
Emanuele CanestrariCook MyoSite, Inc., Pittsburgh, Pennsylvania, U.S.A.
Ron J JankowskiCook MyoSite, Inc., Pittsburgh, Pennsylvania, U.S.A.
Peter C BelafskyDepartment of Otolaryngology-Head and Neck Surgery, University of California, Davis Medical Center, Sacramento, California, U.S.A.
University of California Davis Medical Center · USCook Research (United States) · USCalifornia Institute for Regenerative Medicine · US

Funding

UC Davis Clinical and Translational Science CenterUL1TR001860 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KENYON, NICHOLAS J., LYLES, COURTNEY REES · 2016 to 2025
$47.3M
Institutional Career Development Core (KL2)KL2TR001859 · NCATS · UNIVERSITY OF CALIFORNIA AT DAVIS · PI HOLMES, JAMES F. · 2016 to 2025
$10.1M
Training Program In Basic & Translational Cardiovascular ScienceT32HL086350 · NHLBI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI Martin Cadeiras, David A. Liem · 2008 to 2026
$7.1M
NCATS NIH HHS KL2 TR001859NCATS NIH HHS UL1 TR001860NHLBI NIH HHS T32 HL086350
6 · The paper itself

Abstract

objectives/hypothesisTo evaluate the safety and potential efficacy of autologous muscle-derived cells (AMDCs) for the treatment of swallowing impairment following treatment for oropharynx cancer. STUDY

designProspective, phase I, open label, clinical trial.

methodsOropharynx cancer survivors disease free ≥2 years post chemoradiation were recruited. All patients had swallowing impairment but were not feeding tube dependent (Functional Oral Intake Scale [FOIS] ≥ 5). Muscle tissue (50-250 mg) was harvested from the vastus lateralis and 150 × 10

resultsTen individuals were enrolled. 100% (10/10) were male. The mean age of the cohort was 65 (±8.87) years. No serious adverse event occurred. Mean tongue pressure increased significantly from 26.3 (±11.1) to 31.8 (±9.5) kPa (P = .017). The mean penetration-aspiration scale did not significantly change from 5.6 (±2.1) to 6.8 (±1.8), and the mean FOIS did not significantly change from 5.4 (±0.5) to 4.6 (±0.7). The incidence of pneumonia was 30% (3/10) and only 10% (1/10) experienced deterioration in swallowing function throughout 2 years of follow-up. The mean eating assessment tool (EAT-10) did not significantly change from 24.1 (±5.57) to 21.3 (±6.3) (P = .12).

conclusionResults of this phase I clinical trial demonstrate that injection of 150 × 10 LEVEL OF EVIDENCE: 3 Laryngoscope, 132:523-527, 2022.

Indexed as

AgedCell TransplantationDeglutition DisordersFluoroscopyHead and Neck NeoplasmsHumansMaleManometryMuscle CellsProspective Studiesmuscle-derived cellsOropharynx cancerswallowing impairment

Identifiers

PMID33988246
PMCPMC8909914
OpenAlexW3163700476

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.