Evidence map›Paper›PMID 28247202›Full record

ReviewJournal of bioethical inquiry2017

Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

Tamra Lysaght, Ian H Kerridge, Douglas Sipp, Gerard Porter, Benjamin J Capps

Abstract readComparative StudyReview
PubMed Publisher
In one paragraph

Review in Journal of bioethical inquiry, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Review
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  13. Sex, Drugs, and a Few Other Things.Journal of bioethical inquiry · 2017
    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

5 authors.

Tamra LysaghtCentre for Biomedical Ethics, National University of Singapore, Level 2 Block MD11, Clinical Research Centre, 10 Medical Drive, 117576, Singapore, Singapore. tlysaght@nus.edu.sg.ORCID http://orcid.org/0000-0002-7125-4206
Ian H KerridgeCentre for Values, Ethics and the Law in Medicine, University of Sydney, Medical Foundations Building K25, Sydney, NSW, 2006, Australia.
Douglas SippRIKEN Centre for Developmental Biology, 2-2-3 Minatojima-minamimachi Chuou-ku, Kobe, 650-004, Japan.
Gerard PorterSchool of Law, Edinburgh University, Old College, South Bridge, Edinburgh, EH8 9YL, Scotland.
Benjamin J CappsDepartment of Bioethics, Dalhousie University, 5849 University Avenue, Room C-315, CRC Bldg, PO Box 15000, Halifax, NS, B3H 4R2, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

Indexed as

Ethics, MedicalGovernment RegulationInternational CooperationStem Cell TransplantationTransplantation, AutologousAdult Stem CellsAustraliaCross-Cultural ComparisonHumansJapanMoralsSingaporeUnited KingdomUnited StatesVulnerable PopulationsBioethicsMedical lawScience regulationStem cell therapies

Identifiers

PMID28247202

What OpenQuestion holds

Textmetadata
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.