Evidence map›Paper›PMID 34013781›Full record

ReviewCell transplantation

Selecting a Cell Engineering Methodology During Cell Therapy Product Development.

Lauren M Timmins, Alexandra M Burr, Kristina Carroll, Robert Keefe, Matthew Teryek, Louis J Cantolupo, Johannes C M van der Loo, Thomas R J Heathman, Adam Gormley, David Smith and 1 more

Abstract readReview
In one paragraph

Review in Cell transplantation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
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

11 authors.

Lauren M TimminsDepartment of Biomedical Engineering, 242612Rutgers University, Piscataway Township, NJ, USA.ORCID 0000-0002-8776-4665
Alexandra M BurrDepartment of Biomedical Engineering, 242612Rutgers University, Piscataway Township, NJ, USA.ORCID 0000-0002-7954-3619
Kristina CarrollDepartment of Biomedical Engineering, 242612Rutgers University, Piscataway Township, NJ, USA.
Robert KeefeMaxCyte, Inc, Gaithersburg, MD, USA.
Matthew TeryekDepartment of Biomedical Engineering, 242612Rutgers University, Piscataway Township, NJ, USA.
Louis J CantolupoConsulting, LLC, Butterworth Place NW, Washington, DC, USA.
Johannes C M van der Loo531594The Raymond G. Perelman Center for Cellular and Molecular Therapeutics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Thomas R J HeathmanOri Biotech North America, INC, Woodcliff Lake, NJ, USA.
Adam GormleyDepartment of Biomedical Engineering, 242612Rutgers University, Piscataway Township, NJ, USA.
David SmithMinaris Regenerative Medicine, LLC, Allendale, NJ, USA.ORCID 0000-0003-2726-9192
Biju ParekkadanDepartment of Biomedical Engineering, 242612Rutgers University, Piscataway Township, NJ, USA.

Funding

X-RAY STRUCTURE OF RIFM PROTEIN FROM THE BIOSYNTHESIS PATHWAY OF THE ANSAMYCIN AP41RR012408 · NCRR · BROOKHAVEN SCIENCE ASSOC-BROOKHAVEN LAB · PI MARIUZZA, ROY A · 1998 to 2011
$32.2M
Artificial, Humanized Stem Cell NichesR01EB012521 · NIBIB · RUTGERS, THE STATE UNIV OF N.J. · PI PAREKKADAN, BIJU · 2011 to 2021
$6.0M
Organ Design and Engineering Training Program (ODET Program)T32EB016652 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI BONVENTRE, JOSEPH VINCENT · 2014 to 2023
$3.5M
Rutgers Biotechnology Training ProgramT32GM135141 · NIGMS · RUTGERS, THE STATE UNIV OF N.J. · PI ANN M. STOCK, Martin L Yarmush · 2020 to 2026
$3.5M
Theranostic approach to transplant rejection using engineered cell biosensorsR21AI134116 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI PAREKKADAN, BIJU, UYGUN, KORKUT · 2018 to 2019
$463k
NCRR NIH HHS P41 RR012408NIAID NIH HHS R21 AI134116NIBIB NIH HHS R01 EB012521NIBIB NIH HHS T32 EB016652NIGMS NIH HHS T32 GM135141
6 · The paper itself

Abstract

When considering the development pathway for a genetically modified cell therapy product, it is critically important that the product is engineered consistent with its intended human use. For scientists looking to develop and commercialize a new technology, the decision to select a genetic modification method depends on several practical considerations. Whichever path is chosen, the developer must understand the key risks and potential mitigations of the cell engineering approach. The developer should also understand the clinical implications: permanent/memory establishment versus transient expression, and clinical manufacturing considerations when dealing with transplantation of genetically engineered cells. This review covers important topics for mapping out a strategy for developers of new cell-based therapeutics. Biological, technological, manufacturing, and clinical considerations are all presented to map out development lanes for the initiation and risk management of new gene-based cell therapeutic products for human use.

Indexed as

Cell- and Tissue-Based TherapyCell EngineeringHumanscell therapygene therapygenetic engineeringmanufacturingproduct developmentviral vector

Identifiers

PMID34013781
PMCPMC8145581

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.