Information For Authors

Our dynamic Author Benefits Program provides you with end-to-end benefits that ensure your hard work pays off and your published manuscript gets the attention it deserves not just upon publication, but permanently.

 

Summary of Journals in the Human Gene Therapy Program

Human Gene Therapy (HGT) is our flagship journal having the richest tradition of any journal in the field of cell and gene therapy. Human Gene Therapy just celebrated its 25th anniversary and has published over 4,000 papers, reviews, and editorials. Over the last 2 years we launched two sibling journals including Human Gene Therapy Methods (HGT Methods) and Human Gene Therapy Clinical Development (HGT CD). In assessing your manuscript for submission to one of these three journals, please consider the following criteria:

Human Gene Therapy

The flagship journal will consider papers of very high quality that broadly fall under the scope of cell and gene therapy. Some general categories include: studies evaluating novel approaches of cell and gene therapy in pre-clinical and clinical models; development of novel technologies; studies that help define mechanisms of action of cell and gene therapies; host interactions to vector and transplanted cells; and high-impact new methods and clinical trials. Manuscripts on these topics may be submitted in the form of an original research article, high impact protocol, or Image in Cell and Gene Therapy. Invited review articles and commentaries are usually solicited by the Editorial Board, but we also welcome unsolicited submissions of this type. The Editors may quickly reject a manuscript soon after submission without external review if it falls outside the scope of the Journal or would not likely meet our high standards required for publication. Alternatively, the Editor-In-Chief may determine the manuscript is more suitable for one of the sibling journals as described below.

Human Gene Therapy Methods

Human Gene Therapy Methods is a member of the Human Gene Therapy journal franchise with a focus on key technological advances in all areas of cell and gene therapy including basic research. HGT Methods publishes original research articles, operational protocols, invited review articles and Images in Cell and Gene Therapy. As with HGT, invited review articles and commentaries are usually solicited by the Editorial Board, but are welcomed through a pre-submission editor inquiry. Submissions that describe key technological advances such as techniques for detecting transgene expression, improved vector design, manufacturing advancements and product testing assays are preferentially chosen for this journal.

Human Gene Therapy Clinical Development

This journal includes pre-clinical papers focusing on pharmacology/toxicity/bio-distribution experiments used in the review of proposed clinical trials and will contain sufficient information to allow referencing between products within the same technology platform when appropriate. If the safety studies help define novel mechanisms and/or is of very broad interest to the field, it should be considered for publication in Human Gene Therapy. Recognizing the importance of all clinical data in the formative stages of the field, HGT Clinical Development will publish clinical trials of gene and cell therapy including those which are confirmatory or negative; if the clinical trial is novel and/or reports positive data, it should be considered for publication in Human Gene Therapy.

The criteria for publishing pre-clinical safety studies and clinical trials in HGT Clinical Development will be different than in most journals. We will consider the manuscript appropriate for review if the data are collected in a way that supports the conclusions and are useful in progressing the clinical development of the product; the studies do not have to be novel or to discern mechanisms. HGT Clinical Development is an excellent venue for publishing additional topics including production and characterization data of gene and cell therapy products; selected clinical protocols which describe first-in-human applications of cell and gene therapy; and topical issues related to the commercial development of gene and cell therapy products.

Manuscripts must be submitted online using the following URL:

http://mc.manuscriptcentral.com/hum  

Please read all the instructions to authors before submitting your article. The PDF link contains author instructions for submission to HGT, HGT Methods, and HGT Clinical Development.  For more information and all other inquiries on manuscript submission, please contact HGT editorial office HGT@umassmed.edu.

Create an Account in Manuscript Central

If you do not already have an account in Manuscript Central for the Human Gene Therapy journals, you will need to create one.  Once you create your account, you may log in to the system to begin your submission.

 

Instant Online Publication

The Human Gene Therapy program publishes all accepted papers within 72 hours of acceptance in their unedited, uncorrected format.  It is important to note that the information that is published online, and in all indexing services, is pulled directly from the data that is populated into the fields in Manuscript Central – NOT from the manuscript file – when the paper is originally uploaded to the system for peer review.  Consequently, any errors contained in the system will remain on our website and all indexing services, including Medline, until the next revision* of the article is published.  As such, it is critical that authors enter all authors’ names correctly into the system at the time of submission.  Any errors within the manuscript will remain on our website until the subsequent online version is published.

*The next revision will take place after the corresponding author sees page proofs, makes any necessary corrections, and returns the changes to the Publisher.  Once the alterations are completed, the revised version will be published on our website, and the newly corrected information will then be released to Medline/PubMed, in addition to any other indexing services in which the Journal is included.

Please note that the typical time between acceptance of a paper and page proof distribution is approximately 4-8 weeks depending on the length and complexity of the paper.

 

 

Human Gene Therapy Instructions for Authors

 

I. Submission Overview

II. Manuscript Submission Categories

III. Information on Additional Files – cover letter, figures, tables, supplementary information

 

I. Submission Overview

Use of English Language

 

All submissions must be in English. Appropriate use of the English language is a requirement for review and publication in the Human Gene Therapy suite of journals.  For authors whose native language is not English, we suggest using a service that can aid in the translation and rewriting of material into correct and proper English usage.  The Publisher offers this service with a subsidy from the author prior to official submission. For more information, please contact:  Editing@liebertpub.com   It is important to note that employing the use of the Publisher’s service does not guarantee acceptance of any paper.  All submissions are subject to peer review.

 

Selection of Journal during the submission process

During submission, you will be asked to designate your manuscript to Human Gene Therapy or Human Gene Therapy Methods or Human Gene Therapy Clinical Development. Alternatively, you may select “Open,” in which case, the Editor-in-Chief will designate your manuscript to the appropriate journal. If the Editor-in-Chief disagrees with your journal selection but believes it is suited for one of the other two journals, the corresponding author will be notified via e-mail and will have 2 weeks to agree or decline to switch Journals. If the corresponding author declines or does not respond in the allotted time, the manuscript will be withdrawn from consideration.

Manuscript Submission and Copyright Agreement Form

Manuscripts should be submitted with the understanding that they have neither been published, nor are concurrently under consideration for publication elsewhere, except in the form of an abstract. Prior abstract publications should be described in the form of a footnote to the title. Published manuscripts become the sole property of the Journal and will be copyrighted by Mary Ann Liebert, Inc., unless other arrangements are made prior to publication, including CC-BY licensing.  By submitting a manuscript to the Journal, the author(s) agree(s) to each of the above conditions. In addition, the author(s) explicitly assign(s) any copyrighted ownership he/she (they) may have in such manuscript to the Journal. Upon acceptance of any manuscript, all authors will receive a follow-up email with instructions on how to complete our online Copyright Agreement form. It is critical to ensure the accuracy of ALL authors’ email addresses when uploading submissions to Manuscript Central to ensure the proper delivery of all email communications. FAILURE BY ALL AUTHORS TO SUBMIT THIS FORM WILL RESULT IN A DELAY OF PUBLICATION. The corresponding author is responsible for communicating with coauthors to make sure they have completed the online copyright form. Authors not permitted to release copyright must still return the form acknowledging the statement of the reason for not releasing the copyright. Alternatively, the copyright form may be completed by logging in to the system using an author’s credentials.  Enter your Author Center and complete the forms located under “Manuscripts I Have Coauthored,” or “Manuscripts with Decisions” if you are listed as the corresponding author on the paper.

 

 

Changes to Authorship

 

Changes to the author list are generally NOT permitted after submission. If it becomes necessary to adjust authorship for any reason, the change must be approved by the Editor-in-Chief. To request permission, the corresponding author should notify the editorial office at HGT@umassmed.edu. The corresponding author will be required to provide a valid reason for the change in authorship.  All authors will be required to send an email to the Editor-in-Chief acknowledging and approving the change. When the Editorial Office receives an email from all co-authors, the request will be sent to the Editor-in-Chief for a final decision (the Editor reserves the right to deny the request). If alteration to authorship is approved, all necessary copyright forms will need to be submitted.

Fees

  • There are no submission fees for a manuscript to be considered for publication
  • Page charges for the entire Human Gene Therapy suite of journals is set at $75.00 USD per typeset page.
  • The Journal will publish color photographs, but the author will be charged for the cost of color printing. For further details, contact the Publisher at info@liebertpub.com.
  • Open Access:  please contact OpenAccess@liebertpub.com for details.
  • Reprints: please contact Reprints@liebertpub.com for details.

 

Permissions

When reproducing copyrighted material such as figures or tables, the author must obtain permission from the original publisher and submit it concurrently with the manuscript.  Written permission must be obtained from the publisher of the journal or book concerned. The publication from which the figure or table is taken must be listed in the reference list. Finally, a footnote to a reprinted table or the legend of a reprinted figure should read, “Reprinted by permission from Jones et al.” and list the appropriate reference. All permissions must be supplied at the time of submission. 

Peer-review process – Competing interests

                For Reviewers

The Editors depend on the discretion of any invited reviewer to state whether or not they have any type of conflict with any of the authors on the manuscript. Such conflicts might include recent or ongoing collaborations with the authors; having previously reviewed the manuscript in its draft stages; the reviewer is in direct competition with the authors or has a financial interest in the outcome of the manuscript. Editors will take this information into consideration when deciding whether or not to use the reviewer, or in evaluation of the reviewer’s comments. Should the reviewers feel they cannot be objective in their review for financial, personal, or other reasons, they are expected to decline the invitation to review the manuscript.

We do not exclude reviewers who previously reviewed a specific manuscript for another journal. The comments offered by a qualified reviewer are valuable to the peer-review process and it is important for the reviewer to consider that the author may have already revised the manuscript based on his/her previous comments. 

                Papers Authored by the Editor-in-Chief and/or Associate Editors

The Editor-in-Chief and Associate Editors will recuse themselves from participating in the review process of any manuscript in which there is a potential or actual competing interest.

Peer-review process - Confidentiality 

Editors and reviewers must maintain strict confidentiality of manuscripts during the peer-review process. Sharing a manuscript in whole or in part, outside the scope of what is necessary for assessment, is impermissible prior to the manuscript’s official publication date. 

Sharing of Materials Policy

Authors must honor any reasonable request for materials, methods, or data necessary to reproduce or validate the research findings.

Preprints

Human Gene Therapy recognizes the growing popularity of community non-peer-reviewed preprint repositories such as bioRxiv, arXiv, ChemRxiv, PeerJ Preprints, etc. Deposition of a preprint on a preprint server will not impact consideration of any manuscript submitted to Human Gene Therapy. The existence of a publicly available preprint should be declared upon submission.

Cover Art

We encourage authors of manuscripts accepted by the flagship journal, Human Gene Therapy, to submit interesting images for consideration of publication on the Journal cover. This includes images that were not published within the manuscript, but related to the content. Please ensure they are not submitted or published elsewhere. Images should be high resolution—at least 300 dpi and measuring 5"×5"—.eps, .tif or .tiff files, and saved as CMYK, not RGB. Send images or questions to HGT@umassmed.edu.

Page Proofs

Page proofs will be sent to the (one) corresponding author as designated when the manuscript was uploaded to Manuscript Central.  It is the corresponding author’s responsibility to share the page proofs with co-authors and to coordinate all authors’ corrections into one proof.  The Publisher will not accept corrections from multiple authors.

Changes in authorship in page proofs are NOT permitted under any circumstance.

 

Reprints

Reprints may be ordered by following the special instructions that will accompany the proofs, and should be ordered at the time the corresponding author returns the corrected page proofs to the Publisher as reprints ordered after the issue is printed will be charged at a substantially higher rate.

Press Releases

HGT, HGT Methods and HGT Clinical Development will distribute or make available short press releases on newsworthy articles.

Plagiarism Policy and Information

Human Gene Therapy is committed to maintaining the integrity of the peer review process by upholding the highest standards for all articles we publish. All accepted manuscripts will be processed through plagiarism detection software. Plagiarized manuscripts will be rejected immediately. While a manuscript submission may contain some redundancy in language and content compared to work previously published by authors, self-plagiarism can infringe upon a publisher’s copyright and it is unacceptable for publication in HGT. Please see this website for more information about our automated system and how to avoid self-plagiarism.

http://www.crossref.org/crosscheck/crosscheck_for_researchers.html 

 

Patient Release and Consent

 

If applicable, it is incumbent upon the author(s) to obtain patient release statements of permission to reproduce any identifiable images of patients.  The submitting author should provide written confirmation of this critical information.  Acceptable forms of consent statements are emails or letters.  The Journal does not provide a generic patient release form.

 

The written consent must contain specific information about the patient's name, age, and if pertinent, conservatorship -- as well as stated permission -- granting the Journal the rights to publish the photograph within its pages (which includes the name of the Journal and article title). 

Publisher

With the addition of HGT Clinical Development in 2013, 22 issues in the Human Gene Therapy Journal franchise are published annually by Mary Ann Liebert, Inc., 140 Huguenot Street, New Rochelle, NY 10801-5215. Telephone: 914-740-2100; Fax: 914-740-2108; Email: info@liebertpub.com; Online: www.liebertpub.com


 

II. Manuscript Submission Categories

1)       Research Articles

  1. General
  2. Pre-clinical Safety Assessments (HGT CD)

2)      Images in Gene and Cell Therapy (HGT and HGT Methods)

3)      Protocols

  1. Methods Protocols (HGT and HGT Methods)
  2. Clinical Protocols (HGT CD)

4)      Invited Reviews

5)       Commentaries and Editorials

6)       Letters to the Editor(s)

1)Research Articles

This format represents the majority of papers published in the HGT Journal franchise. The general format is summarized below followed by a specific formatting style for pre-clinical safety assessment submissions. Please note that the format for individual submission types such as protocols, images, and review articles refers to this section on general formatting rules, but has additional instructions that are described in the appropriate section.  a. General Format

Main text file headers (each header starts on a new page)

Title page. (Include institutional affiliation(s), corresponding author information, and short title)

Abstract. (word limit differs for each submission type)

Introduction.

Materials and Methods.

Results.

Discussion.

Acknowledgments.

        Author Disclosure Statement. (must be included after acknowledgments)

References. (Please use the updated and revised style found on the HGT website.  (At this time, the revised style is not yet available through EndNote®.  The Publisher is working to have this adjusted.)

 

Additional Files:

Cover Letter. (State co-authors approval and statement on non-duplicate submission)

Figure Legends. (.doc, .docx)

Figures. (Label figures, but do not include the legend. Save as .tif, .tiff, or .eps with a minimum 300 x 300 dpi)

Table.  (.doc, .docx)

Supplementary Information. Any file type accepted.

Title page. The title page is the first page of the main text file. It should contain the title of article, the name(s) of author(s), institutional affiliation(s), and the name and contact information to whom correspondence should be directed (use complete address, email and phone number). Only one corresponding author should be listed on a manuscript. (Corresponding authorship should be determined at the time of submission.) A short title consisting of 50 characters or less should also be included.

Abstract. For research articles, reviews, and clinical protocols, the abstract should be limited to 300 words. General protocol submissions should limit the abstract to 100 words.

Introduction. In this section, follow general guidelines for writing research articles. Provide context for the reported studies by including sufficient background information. Describe the rationale and summarize the major findings reported in the study.

Materials and Methods. Please provide sufficient information to allow for a qualified third party to attempt to reproduce your work. Please include a statement confirming that all experiments performed in animals follow institutional guidelines and regulations.  For human studies, please include a statement that an informed consent was signed by all subjects.  For more information, see Informed Consent. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/protection-of-research-participants.html

 

Results. We prefer that the total number of tables and figures in the printed manuscript is not greater than six (6). Feel free to include relevant supporting data in a supplementary information section. When doing so, please refer to these data in the presentation of results that appears in the published manuscript.

Discussion. If appropriate, you may integrate the Results and Discussion into a combined section. This often allows for a more concise and understandable story.

Acknowledgments. Any contributor who does not meet the criteria http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html#two for authorship should be listed in the Acknowledgments section. Examples of a contributor may be individuals who provided technical support, writing assistance, or provided research materials. All funding sources, institutional and corporate, should be listed in this section.

Author Disclosure Statement. Immediately following the Acknowledgments section, there should be a header entitled, Author Disclosure Statement. The corresponding author should prepare this statement and include the appropriate information for EACH author, thereby representing that competing financial interests of all authors have been appropriately disclosed according to the policy of the Journal. It is important that all conflicts of interest, whether they are actual or potential, be disclosed. If no conflicts exist, the authors must state “No competing financial interests exist.” Articles submitted without an “Author Disclosure Statement” will be un-submitted so that a statement may be added. Conflicts include:

1. Competing Interests. A competing interest exists when an individual (or the individual’s institution) has financial or personal relationships that may inappropriately influence his actions. These competing interests may be potential or actual, financial or other.

2. Personal Financial Interests. Stocks or shares in a company that may gain or lose financially from publication of the article; consulting fees or other remuneration from an organization that may gain or lose financially from publication of the article; patents or patent applications that are owned by or licensed to companies/institutions that may gain or lose value from publication of the article.

3. Funding. Research support by organizations that may gain or lose financially from publication of the article. This support includes salary, equipment, supplies, honoraria, reimbursement or prepayment for attending symposia, and other expenses.

4. Employment. Recent (within the past 5 years), current, or anticipated employment by an organization that may gain or lose financially from publication of the article.

5. Other Competing Interests. Any personal relationship which may inappropriately affect the integrity of the research reported (by an author) or the objectivity of the review of the manuscript (by a reviewer or Editor), for example, competition between investigators, previous disagreements between investigators, or bias in professional judgment.

References. The reference list should be prepared in numerical order (not alphabetical), and in order of citation within text. References should be double spaced and include the complete titles of cited articles.  Author names should start with a capital letter, but not all caps. If more than three authors are listed on an article, list the first three authors and use et al. (not italic) after the third author’s name. Abbreviations of journal titles in reference section should follow the style of MEDLINE (http://www.ncbi.nlm.nih.gov/nlmcatalog).  Include the year of publication, volume, and inclusive page range.  If work is in press, give journal in which it is to be published, and include "in press" in parenthesis. When references to an unpublished source are used, supply the researcher’s name and date. In-text citations should be cited in order of appearance as a superscripted number outside of the sentence punctuation. (Updated and revised November 2014).

 

Reference Style Examples:

 

Journal citation:

Flotte T.  Gene and cell therapy in 2018:  A look ahead. Hum Gene Ther 2018;29:1-1.

 

Journal Citation (multiple authors): 

Dimmock DO, Brunetti-Pierri N, Palmer D, et al.  Correction of hyperbilirubinemia in gunn rats using clinically relevant low doses of helper-dependent adenoviral vectors.  Hum Gene Ther 2011;22:483-488.

 

[Note:  Abbreviations of journal titles in reference section should follow the style of MEDLINE (http://www.ncbi.nlm.nih.gov/nlmcatalog).]

 

Book citation:

Brosius J. Expression vectors employing A, trp, lac, and lpp-derived promoters. In: Rodriguez RL, Denhardt DT, eds. Vectors: A  Survey of Molecular Cloning Vectors and Their Uses. Stoneham, MA: Butterworth Publishers, 1988: 205–225.

 

When references to an unpublished source are used, supply the researcher’s last name(s) and date of communication in parentheses within the text, followed by a semicolon, and state “unpublished data.”  (Ex:  Jones and Smith, 2018; unpublished data). Do NOT include in the reference list.

 

If work has been submitted** but is still under peer review, supply authors’ names according to the style in the “journal citation” example(s), list the manuscript title, followed by “Submitted; under review, [year of submission].” (Ex: Jones and Smith, 2018; submitted; under review, 2018).  Do NOT include in the reference list.

 

If work has been accepted for publication, but is still in press,** follow the “journal citation” example(s) but include "in press" in parenthesis in place of the volume and page range.  DO include these citations as a formal reference in the reference list.

 

**Note:  “Submitted” and “in press” citations should be updated in the page proofs stage whenever possible.

 

 

b. Format for Pre-clinical Safety Assessments (published in HGT CD)

Manuscripts submitted to HGT Clinical Development describing pre-clinical safety studies should follow a format different than that of regular Research Articles as described in detail below. The organization is: Abstract, Introduction, and a combined Results and Discussion section. Materials and Methods and any additional data should be included in a supplementary section.

Title page and Abstract. Follow general research article style

Introduction. Provide sufficient context to understand the importance of the studies. Comment on the disease being treated and cell and gene therapy approaches being considered. Specifically reference and comment on published data which support the feasibility of the therapeutic approach that is the topic of the safety study.

Results and Discussion. Combine Results and Discussion and include the following sections:

1. Clinical Trial. A brief summary of the proposed clinical trial that the pre-clinical study is/was intended to support should be included in this pre-clinical paper since the reader needs context as to why the pre-clinical study is being performed. Include a description of the investigational agent being evaluated. Refer to the Materials and Methods section for more details regarding the vector/cells.

2. Objectives and Study Design. Describe the goals of the pre-clinical study followed by a detailed description of the actual design of the pre-clinical study. Feel free to use tables and/or figures as necessary to describe study design. Provide a rationale for selection of animal species/animal models and/or cell lines used as well as the basis for actual structure of the study. Include a description of the similarities/differences between the model and humans (e.g., pathophysiology, disease progression, and severity). Also comment on the timing of vector/cell administration relative to disease onset and disease progression.

3. Summary of Data. Primary data should be presented in the manuscript in summary form. A more detailed description of the data should be provided in supplementary information if it is not thoroughly covered in the printed paper (see below). An important challenge will be determining what of the source data should be included in the paper and how will it be distributed between the Results/Discussion section of the printed manuscript vs. in the supplementary section. Please keep tables and figures in the printed manuscript to no greater than six (6). Some guidance is provided below for general categories of papers. 

a. Acute in vivo toxicity. Substantial quantities of data are generated in these studies not all of which should be published. The printed manuscript should describe all positive findings (demonstration of efficacy and toxicities) and pertinent negative findings (the notable absence of toxicities in target organs/tissues) at least in summary form. The printed manuscript should list all assays/test performed and note that they were within normal limits if in fact they were all normal. The supplementary information can provide more detailed information of the pertinent negative and positive findings.

 b. Biodistibution. These data should be described at least in summary form in the printed manuscript; included in the printed manuscript should be details of the assay. The supplementary information can provide data for individual animals if that seems to be of interest.

c. Genotoxicity. All data related to the presence or absence of cell transformation should be included in the manuscript. Some ancillary data such as details of integration or sequence analysis can go in the supplement.

Conclusions. Please discuss the findings in the context of how they will/have influence the design of the clinical trial. Also consider the data in the context of previous work performed with similar investigational agents. This is important in providing a data base relevant to platform technologies to determine if there are common features of the platform that can help predict toxicity. Examples of platforms include bio-distribution studies with a common AAV capsid or genotoxicity studies with lentiviral vectors that share identical genome structures and envelope proteins.

Supplementary information. Feel free to include relevant supporting data in a supplementary information section that will appear in the online only portion of the journal(s). When doing so, please refer to this information and data in the presentation of results that appears in the published manuscript.

1. Materials and Methods

a. Investigational agent. Describe how the vector/cells were prepared including sufficient detail to allow for comparisons to studies using similar vectors/cells. Include all data regarding the characterization of the product.

b. Assays. Describe each assay used in the analysis of the experiment, including information about controls, assay sensitivity and/or specificity if available. Provide information regarding the state of validation of each assay such as: research based, an internal qualified assay, or a contract assay. For histopathology include details about the criteria used for assessing abnormal findings and how and who read the pathology.

c. Procedures. Details regarding non-standard procedures should be provided especially those involving in vivo work such as the conditions of administering the investigational drug.

d. Statistical methods. 

2. Quality assurance. Provide information regarding steps involved in assuring the quality of the data. This can range from a study performed under full GLP to a research based study; the study does not have to be full GLP to be value to the community and relevant to the Journal. Details of the QA program should be provided. Indicate if there was no formal QA program. 

3. Results. Include more detailed data for all relevant findings including positive results and pertinent negative results. The authors have some latitude as to the amount of detail that is required although it should be much more focused than a final study report but more detailed than just a summary table. 

Acknowledgments, Author Disclosure Statement, and References. Follow general research article style.

 

2) Images in Gene and Cell Therapy

Images should tell a research story and capture the imagination as well as provide scientific information about spatial relationships and context.   We invite you to submit your original striking images that illustrate and illuminate your research story and that make a timely and relevant point, emphasize a new and emerging concept, or are stunning and beautiful.  Authors may submit Images to HGT, HGT Methods or in the “OPEN” category and the editor will determine which journal is appropriate depending on the content.

The submission format follows the general Research Article format except where specified below:

  • Main document in Microsoft Word file format (.doc, or .docx) containing a title page, abstract, short text (250-500 words), acknowledgements, author disclosure statement and up to 4 references; and
  • One original color figure. Images must be uploaded in either .eps or .tiff format with a DPI of 300 or greater. The minimum image width is 7 inches. Please see instructions for additional information on acceptable figure formats.

All submissions will be peer reviewed and within 72 hours of acceptance will be deposited to Medline. Submitted images may be considered for use on the cover of the Journal. (Cost for page charges and color printing for this section will be waived through December 1, 2015.)  Submissions received after that date will be subjected to the usual pricing structure of Mary Ann Liebert, Inc. publishers.

 

3) Protocols

HGT-Protocols is a specific category encouraging the publication of operating procedures for methodologies which allow key advances in the field of gene therapy. Protocols can either be formatted for HGT and HGT Methods or for HGT Clinical Development.  The first two submission types should describe protocols that are used in the laboratory and the second type of protocol submission is reserved for clinical protocols involving human subjects.

The scope of acceptable protocol submissions for HGT and HGT Methods encompasses all aspects of vector and vaccine development including production and purification methodologies, assessment of immunotoxicity and/or genotoxicity, regulation of transgene expression and monitoring approaches for cell and gene therapy. The step-by-step protocol provided in HGT-Protocols is intended to establish novel peer-reviewed methodologies and enable technical improvements for specialists and non-specialists in the gene therapy field. The protocol submission should describe a method that has already been used to produce results in a peer-reviewed original research article and should describe a considerable technological advancement when compared to the “state-of-the art” methodology. HGT protocols will be sent out for external review as well as internal review by members of the Editorial Board. Please include reference in the cover letter and introduction to any similar protocols that have previously been published in the manuscript.

a. Methods Protocols (published in HGT and HGT Methods)

HGT Protocol submissions follow the general format of research articles with specific differences outlined in the following section.

Title page. Follow general Research Article style. 

Abstract. The abstract summarizes the methodology and its areas of application (maximum of 100 words). The abstract should allow a non-specialist to make a decision on whether this methodology is of interest.  The focus of the abstract should be to summarize the time required to follow the protocol and the results anticipated with a focus on how this methodology differs from previously published protocols.

 

Introduction. HGT requests a comprehensive introduction that, in general, describes the methodology, highlights the improvements described in this “protocol” compared to the current state-of-the-art, discusses its limitations and in more detail describes the areas of its application. Provide this overview in a format accessible to non-specialists. Authors are encouraged to include figures where appropriate.

 

Experimental Procedure. This section contains the actual protocol. In contrast to the common Material and Methods sections in original research articles, the experimental procedure is to be presented here as a detailed step-by-step protocol. Description of each step has to contain all necessary information required for non-specialists to follow and to set up this methodology. Include figures with schematic presentations of the experimental procedure where appropriate. Indicate critical steps as well as steps at which the protocol can be interrupted. Use subheadings where appropriate. Use short sentences and in active tense.

 

Material. This section contains information on reagents and buffer compositions. Information on reagents should be provided using the following table format:

 

Reagents

Supplier

Specific handling

Storage conditions

 

 

 

 

 

 

 

 

 

Include information on toxicity and precautions required when working with the reagent in the “specific handling” section. When describing buffer composition, authors should include a step-by-step protocol on buffer preparation when appropriate.

 

Troubleshooting. This section is of particular importance for establishing a new methodology. Authors are therefore requested to provide a list outlining sections where specific problems or errors commonly occur. Please refer to the respective critical steps in the Experimental Procedure section and provide a summary of possible causes, solutions, and - if possible - indicating controls that ought to be included.

 

Acknowledgements, Author Disclosure Statement, References, Figures, Tables, and Supplementary Information. Follow general Research Article style.

 

b. Clinical Protocols (published in HGT CD) strong>

In selected cases, we will consider publishing clinical protocols without clinical data. Criteria for acceptance will be the novelty of the proposed trial giving priority to first in human studies. Please submit a pre-submission inquiry to the HGT Clinical Development Editor at wilsonjm@upenn.edu before submitting the protocol focusing on the novelty of the trial.

 The protocol should be no longer than 4,500 words and should be organized as follows:

Cover Page, Abstract, Title page and Abstract. Follow general research article style.

Introduction. Very brief background including description of disease and pre-clinical and clinical data to support the efficacy and safety of the proposed study.

 Study Objectives

Study Design. Include primary and secondary endpoints. Also include in this section a discussion of the dose levels/dose regimens and how they were selected based on pre-clinical data or other clinical studies which use the same or a similar investigational agent.

Subject Selection and Withdrawal.

a. Inclusion Criteria

b. Exclusion Criteria

c. Subject Recruitment and Screening

d. Informed Consent: Include an example of a consent document in Supplementary information

Study Drug. Brief description of the investigational agent and how it is produced

Study Procedures. Include a table of events. Also describe in some detail the specifics of the vector/cell infusion.

Statistical Plan.

Safety and Adverse Events.

a. Definitions

b. Reporting of serious adverse events and unanticipated problems

 Risk/Benefit Assessment.

4) Review Articles

Review articles are usually solicited by the Editorial Board. Unsolicited submissions are welcome, but require positive evaluation of a pre-submission inquiry by the Editorial Board. If the reviewer is open to publication in any HGT journal, the pre-submission inquiry should be submitted to the HGT Clinical Development Editor at wilsonjm@upenn.edu. If found to be of potential interest, a formal submission will be encouraged which, after submission, will be sent out for external review as well as internal review by members of the Editorial Board.

Review Articles for HGT Methods

Review articles provide detailed information on key technologies. They consist of a comprehensive introduction to the technology, followed by a critical assessment on its impact for cell and gene therapy, its current challenges and potential future direction. The pre-submission inquiry should be submitted to HGT Methods Editor Hildegard.Buening@uk-koeln.de

Review Articles for HGT Clinical Development

Review articles submitted to HGT Clinical Development should be evidence-based reviews that highlight recent developments and relevant clinical information in the context of history and development for direct application to gene therapy. A pre-submission inquiry regarding an unsolicited review, commentary, or editorial should be submitted to the HGT Clinical Development Editor wilsonjm@upenn.edu. If found to be of potential interest, a formal submission will be encouraged which, after submission, will be sent out for external review as well as internal review by members of the Editorial Board.

HGT review articles follow the general format of research articles. Permissible deviations from the previously described format are outlined in the following section.

Title Page, Abstract. Follow general research article style.

Main Text. The review article should provide comprehensive information on the respective technology, but should be at the same time as short as possible. Include a short, general introduction and a paragraph describing current limitations and possible future directions. Structure the text by including subheadings. The length should be between 5000-8000 words. Figures and Tables are encouraged, but should be limited to a total number of four.

Acknowledgements, Author Disclosure Statement. Follow general research article style.

References. References should be limited to 50. If applicable, highlight references of particular importance for the reader. Use the same style as for research articles.

Figures, Tables, and Supplementary Information. Follow general research article style

5) Commentaries

These are usually solicited by the Editorial Board, but we welcome unsolicited submissions of this type. A pre-submission inquiry regarding an unsolicited commentary should be submitted to the HGT Clinical Development Editor wilsonjm@upenn.edu.  If found to be of potential interest, a formal submission will be encouraged which, after submission, will be sent out for external review as well as internal review by members of the Editorial board.  Formal submissions can be emailed directly to the Editor of HGT Clinical Development.

6) Letters To The Editor(s) 

Letters to the Editor(s) are welcomed, but with a 500-word limit and no more than one (1) table OR figure, and with a maximum of four (4) references.  Please email the letter to the editorial office at HGT@umassmed.edu

III. Additional Files

Additional files should be submitted separately from the main document. Excluding the cover letter, each file should be labeled at the top of the page.

Cover Letter

Manuscripts of all submission types should be submitted with a cover letter that includes the following information:

  • Summarize the major findings of the manuscript in the context of adding value to the field of gene therapy.
  • List preferred/excluded referees by including their name, contact information and a short description of expertise. Only institutional email addresses will be considered for use in peer review.
  • A confirmation statement that all co-authors have reviewed and approve of the manuscript. The authors must also include a statement that the manuscript has been submitted solely to this journal and is not published, in press, or submitted elsewhere. 
  • Any other information of interest such as special submissions or pre-submission inquiries should also be mentioned in the cover letter.

Illustrations and Tables

Figures. Each figure should be labeled with the figure number and saved individually as a .tif, .tiff, or .eps file. Label figures and tables inside the files in addition to naming the file with the figure or table number (i.e., When figure files are opened, the figure number appears on the figure itself.  If possible please use Arial font for figure text.

When naming your figure files, please label them with the first author’s last name, followed by the figure number (e.g., SmithFigl; SmithTable1). Avoid using punctuation in file names. Submit each figure as an individual file.  Do NOT embed art files into a Word or PDF document and do NOT include figures and/or tables in the manuscript file. Images should not show the name of the manufacturer or reveal patients’ names. Please keep in mind that most figures will need to be sized according to journal style, so please do not submit large figures/graphs that contain small type, as the text within the figure will not be readable after reduction.

Please follow the instructions below to submit figures with the proper DPI and color formatting.

  • Line illustrations must be submitted at 900 DPI.
  • Halftones and color should be submitted at a minimum of 300 dpi.
  • Save as either .tiff, .tif, or .eps files. Do not submit .JPEG files.
  • Color art must be saved as CMYK - not RGB. (N.B., If RGB files are submitted, the files will be converted to CYMK and some color variation will occur.)
  • Black and white art must be submitted as grayscale – not RGB.
  • Do NOT submit PowerPoint, PDF, Bitmap, or Excel as figure or table files.

Additional Information on Converting Figure Files:

Converting Word or Excel files: The best and easiest way to convert Word or Excel files into a format which is suitable for print is to scan them using the below guidelines:

  • All files should be scanned at 100% size
  • At least 300 dpi
  • Final color mode: CMYK
  • Save file as: .tif, .tiff, or .eps

For more direction on how to convert a Power Point slide to acceptable format go to: www.liebertpub.com/MEDIA/pdf/ppconvert.pdf

Figure Legends. A legend should be supplied for each illustration, with all legends numbered consecutively in the order cited in the text, and should NOT be included in the figure image file or in the manuscript file. In a separate document entitled the title Figure Legends, include all figure legends, double-spaced and saved as a .doc or .docx. All symbol definitions should be provided in the figure legend.

Tables. Each table should be labeled with the table number and saved individually as a .doc or .docx file. Use Arabic numerals to number tables. Do not repeat information that is given in the text, and do not make a table for data that can be given in the text in one or two sentences. Provide titles for all tables. Define all acronyms in table footnotes. All other types of table footnotes should be designated using superscript letters, not symbols.

Supplementary Information

We encourage the judicious use of a supplementary (online-only) information section. All information/data in the supplementary information should be referred to in the manuscript proper, including reference to specific tables and figures in the supplementary material. Upload supplementary tables, figures, and legends as separate files, either as “supplementary file” or “supplementary file for review only.” The manuscript should be written so that the paper which appears in the printed journal contains all data which are key to the conclusions and important for the reader to have direct access to when reading the paper. Other supporting data and text are appropriate for the supplementary section.

 

IV. Ordering Files During Submission

Upload manuscript files to our system in the following order:

  • Manuscript
  • Tables
  • Figure Legends
  • Figures
  • Supplementary files

 

Liebert Open Access

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At this time we allow authors to choose between the CC-BY or CC-BY-NonCommercial license. A limited number of journals offer NonCommercial licenses exclusively.

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 *Please note that PubMedCentral, not the Publisher, has sole control over when the paper is made live on PMC.

 

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Authors may archive their preprint manuscripts (version prior to peer review) at any time without restrictions. Authors may archive their postprint manuscripts (accepted version after peer review) in institutional repositories, preprint servers, and research networks after a 12 month embargo. The 12 month embargo period begins when the article is published online. Postprints must not be used for commercial purposes and acknowledgement must be given to the final publication, and publisher, by inserting the DOI number of the article in the following sentence: “Final publication is available from Mary Ann Liebert, Inc., publishers http://dx.doi.org/[insert DOI]”. Authors may archive on their personal website without an embargo provided their manuscript is updated with an acknowledgement to the publisher copyright and final published version.

The final published article (version of record) can never be archived in a repository, preprint server, or research network.

 

Publishing Open Access

Authors that wish to easily comply with funder or institutional open access mandates should consider publishing open access. Liebert Open Access option allows authors to make their research freely available online without restrictions. Additionally, Liebert Open Access option allows authors to retain copyright, archive and share the final published version of their article without restrictions. To publish open access please email openaccess@liebertpub.com or visit Liebert Open Access for more information.

The views, opinions, findings, conclusions and recommendations set forth in any Journal article are solely those of the authors of those articles and do not necessarily reflect the views, policy or position of the Journal, its Publisher, its editorial staff or any affiliated Societies and should not be attributed to any of them.

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