Evidence map›Paper›PMID 34377431›Full record

ReviewJournal of tissue engineering

Current standards and ethical landscape of engineered tissues-3D bioprinting perspective.

Muthu Parkkavi Sekar, Harshavardhan Budharaju, Allen Zennifer, Swaminathan Sethuraman, Niki Vermeulen, Dhakshinamoorthy Sundaramurthi, Deepak M Kalaskar

Open access · goldAbstract readReview
In one paragraph

Review in Journal of tissue engineering. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 2 pooled it
6.0field-weighted citation impact, top 3% 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.

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

60 citing papers in PubMed, 2 syntheses or guidelines pooled it, 128 citations in OpenAlex.

  1. Pooled it
  2. Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues.Transplant international : official journal of the European Society for Organ Transplantation · 2022
    Pooled it
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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

7 authors at 3 institutions in 2 countries.

Muthu Parkkavi SekarTissue Engineering & Additive Manufacturing Lab, Centre for Nanotechnology & Advanced Biomaterials, ABCDE Innovation Centre, School of Chemical & Biotechnology, SASTRA Deemed University, Thanjavur, Tamil Nadu, India.
Harshavardhan BudharajuTissue Engineering & Additive Manufacturing Lab, Centre for Nanotechnology & Advanced Biomaterials, ABCDE Innovation Centre, School of Chemical & Biotechnology, SASTRA Deemed University, Thanjavur, Tamil Nadu, India.
Allen ZenniferTissue Engineering & Additive Manufacturing Lab, Centre for Nanotechnology & Advanced Biomaterials, ABCDE Innovation Centre, School of Chemical & Biotechnology, SASTRA Deemed University, Thanjavur, Tamil Nadu, India.
Swaminathan SethuramanTissue Engineering & Additive Manufacturing Lab, Centre for Nanotechnology & Advanced Biomaterials, ABCDE Innovation Centre, School of Chemical & Biotechnology, SASTRA Deemed University, Thanjavur, Tamil Nadu, India.
Niki VermeulenDepartment of Science, Technology and Innovation Studies, School of Social and Political Science, University of Edinburgh, High School Yards, Edinburgh, UK.
Dhakshinamoorthy SundaramurthiTissue Engineering & Additive Manufacturing Lab, Centre for Nanotechnology & Advanced Biomaterials, ABCDE Innovation Centre, School of Chemical & Biotechnology, SASTRA Deemed University, Thanjavur, Tamil Nadu, India.ORCID https://orcid.org/0000-0001-5493-3613
Deepak M KalaskarUCL Division of Surgery and Interventional Science, London, UK.ORCID https://orcid.org/0000-0002-0576-1816
SASTRA University · INUniversity College London · GBUniversity of Edinburgh · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tissue engineering is an evolving multi-disciplinary field with cutting-edge technologies and innovative scientific perceptions that promise functional regeneration of damaged tissues/organs. Tissue engineered medical products (TEMPs) are biomaterial-cell products or a cell-drug combination which is injected, implanted or topically applied in the course of a therapeutic or diagnostic procedure. Current tissue engineering strategies aim at 3D printing/bioprinting that uses cells and polymers to construct living tissues/organs in a layer-by-layer fashion with high 3D precision. However, unlike conventional drugs or therapeutics, TEMPs and 3D bioprinted tissues are novel therapeutics and need different regulatory protocols for clinical trials and commercialization processes. Therefore, it is essential to understand the complexity of raw materials, cellular components, and manufacturing procedures to establish standards that can help to translate these products from bench to bedside. These complexities are reflected in the regulations and standards that are globally in practice to prevent any compromise or undue risks to patients. This review comprehensively describes the current legislations, standards for TEMPs with a special emphasis on 3D bioprinted tissues. Based on these overviews, challenges in the clinical translation of TEMPs & 3D bioprinted tissues/organs along with their ethical concerns and future perspectives are discussed.

Indexed as

3D bioprintingethical concernsregulations & standardsstem cellsTEMPstissue engineering

Identifiers

PMID34377431
PMCPMC8330463
OpenAlexW3192216168

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.