Evidence map›Paper›PMID 30567696›Full record

SynthesisJournal of medical Internet research2018

Decision Support Tools for Regenerative Medicine: Systematic Review.

Ching Lam, Edward Meinert, Abrar Alturkistani, Alison R Carter, Jeffrey Karp, Aidong Yang, David Brindley, Zhanfeng Cui

Abstract readSystematic Review
In one paragraph

Synthesis in Journal of medical Internet research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

8 authors.

Ching LamDepartment of Engineering Science, Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.ORCID 0000-0002-9137-749X
Edward MeinertHealthcare Translation Research Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-2484-3347
Abrar AlturkistaniGlobal Digital Health Unit, Department of Primary Care and Public Health, Imperial College London, London, United Kingdom.ORCID 0000-0001-7935-8870
Alison R CarterHealthcare Translation Research Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-0907-5466
Jeffrey KarpDivision of Engineering in Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.ORCID 0000-0002-4752-7374
Aidong YangDepartment of Engineering Science, Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.ORCID 0000-0001-5974-247X
David BrindleyHealthcare Translation Research Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.ORCID 0000-0002-5166-8583
Zhanfeng CuiDepartment of Engineering Science, Institute of Biomedical Engineering, University of Oxford, Oxford, United Kingdom.ORCID 0000-0002-9251-9752

Funding

Engineered Induction of a Stem Cell Homing ResponseR01HL095722 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI KARP, JEFFREY MICHAEL · 2010 to 2018
$3.9M
NHLBI NIH HHS R01 HL095722
6 · The paper itself

Abstract

backgroundDecisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients.

objectiveThe objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine.

methodsWe systematically searched MEDLINE to identify articles on decision support tools relevant to tissue engineering, and cell and gene therapy, with the aim of identifying gaps for future decisional tool development. We included published studies in English including a description of decisional tools in regenerative medicines. We extracted data using a predesigned Excel table and assessed the data both quantitatively and qualitatively.

resultsWe identified 9 articles addressing key decisions in manufacturing and product development challenges in cell therapies. The decision objectives, parameters, assumptions, and solution methods were analyzed in detail. We found that all decisional tools focused on cell therapies, and 6 of the 9 reviews focused on allogeneic cell therapy products. We identified no available tools on tissue-engineering and gene therapy products. These studies addressed key decisions in manufacturing and product development challenges in cell therapies, such as choice of technology, through modeling.

conclusionsOur review identified a limited number of decisional tools. While the monoclonal antibodies and biologics decisional tool domain has been well developed and has shown great importance in driving more cost-effective manufacturing processes and better investment decisions, there is a lot to be learned in the regenerative medicine domain. There is ample space for expansion, especially with regard to autologous cell therapies, tissue engineering, and gene therapies. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated.

Indexed as

Cell- and Tissue-Based TherapyDecision MakingHumansRegenerative Medicinecell- and tissue-based therapycell therapydecisional tooldecision support techniquesregenerative medicinesystematic review

Identifiers

PMID30567696
PMCPMC6315273

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.