Evidence map›Paper›PMID 38764240›Full record

ArticleInternational journal of stem cells2024

Essential Guidelines for Manufacturing and Application of Organoids.

Sun-Ju Ahn, Sungin Lee, Dayeon Kwon, Sejeong Oh, Chihye Park, Sooyeon Jeon, Jin Hee Lee, Tae Sung Kim, Il Ung Oh

Abstract read
In one paragraph

Article in International journal of stem cells, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
–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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guiding Principles: Reporting Elements for Gastrointestinal Organoid Research.Cellular and molecular gastroenterology and hepatology · 2026
    Guideline
  2. Pooled it
  3. Review
  4. Review
  5. Review
  6. Review
  7. Biobanked Liver Organoids: A Roadmap for Precision Hepatology.BioEssays : news and reviews in molecular, cellular and developmental biology · 2026
    Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. A Shared Framework for Gastrointestinal Organoid Research: It's Time.Cellular and molecular gastroenterology and hepatology · 2026
    Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

9 authors.

Sun-Ju AhnDepartment of Biophysics, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0000-0002-8325-2312
Sungin LeeInstitute of Quantum Biophysics, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0000-0002-4260-2160
Dayeon KwonInstitute of Quantum Biophysics, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0009-0009-0965-8718
Sejeong OhInstitute of Quantum Biophysics, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0009-0006-0708-8270
Chihye ParkInstitute of Quantum Biophysics, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0009-0004-7237-9547
Sooyeon JeonInstitute of Quantum Biophysics, Sungkyunkwan University, Suwon, Korea.ORCID https://orcid.org/0000-0003-4585-2111
Jin Hee LeeOrganoid Standards Initiative.ORCID https://orcid.org/0009-0009-9012-7163
Tae Sung KimOrganoid Standards Initiative.ORCID https://orcid.org/0009-0004-7304-3615
Il Ung OhOrganoid Standards Initiative.ORCID https://orcid.org/0009-0004-8917-0838

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.

Indexed as

Embryonic stem cellsInduced pluripotent stem cellsOrganoidsQualityRegulationsStem cells

Identifiers

PMID38764240
PMCPMC11170116

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.