Evidence map›Paper›PMID 23129637›Full record

ArticleProceedings of the National Academy of Sciences of the United States of America2012

Early responses to adenoviral-mediated transfer of the aquaporin-1 cDNA for radiation-induced salivary hypofunction.

Bruce J Baum, Ilias Alevizos, Changyu Zheng, Ana P Cotrim, Shuying Liu, Linda McCullagh, Corinne M Goldsmith, Peter D Burbelo, Deborah E Citrin, James B Mitchell and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Proceedings of the National Academy of Sciences of the United States of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02446249 (Open-Label, Dose-Escalation Study Evaluating the Safety of a Single Administration of an Adeno-Associated Virus Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals With Irradiation-Induced Parotid Salivary Hypofunction), which is not on this map. Cited by 105 papers.

0numbers the graph read from it
0cells of the map it votes in
105citing papers in PubMed
8.9field-weighted citation impact, top 2% 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.

NCT02446249 phase1completednot on this mapstarted 2015, after this paper: background citation

Open-Label, Dose-Escalation Study Evaluating the Safety of a Single Administration of an Adeno-Associated Virus Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals With Irradiation-Induced Parotid Salivary Hypofunction

TypeinterventionalSponsorMeiraGTx, LLCRan2015 to 2026Enrolled17ConditionsSquamous Cell Head and Neck Cancer, Radiation Induced Xerostomia, Salivary HypofunctionArmsAAV2hAQP1
3 · Its place in the literature

Who cites it

105 citing papers in PubMed, 192 citations in OpenAlex.

  1. Trial
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  12. The Oral Microbial Ecosystem in Age-Related Xerostomia: A Critical Review.International journal of molecular sciences · 2024
    Review
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45 more citing papers are in PubMed but not listed here.

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

22 authors at 6 institutions in 1 country.

Bruce J BaumMolecular Physiology and Therapeutics Branch, and Neurobiology and Pain Therapeutics Section, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892, USA. bbaum@mail.nih.gov
Ilias Alevizos
Changyu Zheng
Ana P Cotrim
Shuying Liu
Linda McCullagh
Corinne M Goldsmith
Peter D Burbelo
Deborah E Citrin
James B Mitchell
Liesl K Nottingham
Susan F Rudy
Carter Van Waes
Millie A Whatley
Jaime S Brahim
John A Chiorini
Stamatina Danielides
R James Turner
Nicholas J Patronas
Clara C Chen
Nikolay P Nikolov
Gabor G Illei
National Institutes of Health · USCenter for Cancer Research · USMolecular Oncology (United States) · USNational Institute of Dental and Craniofacial Research · USNational Institute on Deafness and Other Communication Disorders · USUniversity of Maryland, Baltimore · US

Funding

Adeno-associated Virus Biology And Utilization For Gene TransferZIADE000695 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI CHIORINI, JAY · 2009 to 2025
$36.6M
NIDCD Core for Clinical Research and CareZIDDC000075 · NIDCD · NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS · PI LEVY, JOSHUA · 2009 to 2025
$33.6M
Clinical Investigations of Sjogren's SyndromeZIADE000704 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI WARNER, BLAKE · 2009 to 2025
$22.3M
Mechanisms of Normal Tissue Toxicity From IrradiationZIABC010850 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CITRIN, DEBORAH · 2009 to 2025
$19.4M
Modulation of Therapeutic ResponseZIASC006321 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI MITCHELL, JAMES · 2009 to 2025
$17.3M
MicroRNA effect on salivary flow of Sjogren's syndrome patientsZIADE000733 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI ALEVIZOS, ILIAS · 2010 to 2017
$5.2M
Mechanisms of Pain and Immune ProcessesZIACL090034 · CLC · CLINICAL CENTER · PI MANNES, ANDREW · 2014 to 2025
$0k
Intramural NIH HHS
6 · The paper itself

Abstract

No conventional therapy exists for salivary hypofunction in surviving head and neck cancer patients with Radiation Therapy Oncology Group late grade 2-3 toxicity. We conducted a phase I clinical trial to test the safety and biologic efficacy of serotype 5, adenoviral-mediated aquaporin-1 cDNA transfer to a single previously irradiated parotid gland in 11 subjects using an open label, single-dose, dose-escalation design (AdhAQP1 vector; four dose tiers from 4.8 × 10(7) to 5.8 × 10(9) vector particles per gland). Treated subjects were followed at scheduled intervals. Multiple safety parameters were measured and biologic efficacy was evaluated with measurements of parotid salivary flow rate. Symptoms were assessed with a visual analog scale. All subjects tolerated vector delivery and study procedures well over the 42-d study period reported. No deaths, serious adverse events, or dose-limiting toxicities occurred. Generally, few adverse events occurred, and all were considered mild or moderate. No consistent changes were found in any clinical chemistry and hematology parameters measured. Objective responses were seen in six subjects, all at doses <5.8 × 10(9) vector particles per gland. Five of these six subjects also experienced subjective improvement in xerostomia. AdhAQP1 vector delivery to a single parotid gland was safe and transfer of the hAQP1 cDNA increased parotid flow and relieved symptoms in a subset of subjects.

Indexed as

Genetic TherapyAdenoviridaeAgedAquaporin 1CitratesDNA, ComplementaryGalliumHumansMaleMiddle AgedRadiation InjuriesRadionuclide ImagingSalivary Gland DiseasesAquaporin 1CitratesDNA, ComplementaryGalliumgallium citrate

Identifiers

PMID23129637
PMCPMC3511089
OpenAlexW2087760897

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.