Evidence map›Paper›PMID 38958627›Full record

ReviewCytotherapy2024

Considerations for the development of iPSC-derived cell therapies: a review of key challenges by the JSRM-ISCT iPSC Committee.

Marinna Madrid, Uma Lakshmipathy, Xiaokui Zhang, Kapil Bharti, Dominic M Wall, Yoji Sato, George Muschler, Anthony Ting, Nathan Smith, Shuhei Deguchi and 6 more

Abstract readReview
In one paragraph

Review in Cytotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing 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

35 citing papers in PubMed.

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  12. Challenges and opportunities of human iPSC-derived NK as "Off-the-shelf" cellular therapies.Journal of experimental & clinical cancer research : CR · 2025
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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

16 authors.

Marinna MadridCellino Biotech, Cambridge, USA.
Uma LakshmipathyPharma Services, Thermo Fisher Scientific, Carlsbad, USA.
Xiaokui ZhangAspen Neuroscience Inc., San Diego, USA.
Kapil BhartiNational Eye Institute of the National Institutes of Health, Bethesda, USA.
Dominic M WallPeter MacCallum Cancer Centre, Melbourne Australia; Cell Therapies Pty Ltd, Melbourne, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Australia.
Yoji SatoNational Institute of Health Sciences, Kawasaki, Japan.
George MuschlerCleveland Clinic, Cleveland, USA.
Anthony TingBRL C&GT consulting, LLC., Cleveland, USA.
Nathan SmithCell Therapies Pty Ltd, Melbourne, Australia.
Shuhei DeguchiCIRA Foundation, Facility for iPS Cell Therapy (FiT), Kyoto, Japan.
Shin KawamataCyto-Facto Inc., Kobe, Japan; Kobe University, Kobe, Japan. Electronic address: kawamata.shin@cytofacto.com.
Jennifer C MooreSampled, New York City, USA.
Bar MakovozCellino Biotech, Cambridge, USA.
Stephen SullivaniPSirius, Paris, France; Lindville Bio, London, UK.
Veronica FalcoLindville Bio, London, UK.
Arwa Z Al-RiyamiDepartment of Hematology, Sultan Qaboos University Hospital, University Medical City, Muscat, Oman.

Funding

Developing autologous iPSC-RPE based IND for AMD patientsZIAEY000542 · NEI · NATIONAL EYE INSTITUTE · PI BHARTI, KAPIL · 2014 to 2025
$24.2M
Intramural NIH HHS ZIA EY000542
6 · The paper itself

Abstract

Since their first production in 2007, human induced pluripotent stem cells (iPSCs) have provided a novel platform for the development of various cell therapies targeting a spectrum of diseases, ranging from rare genetic eye disorders to cancer treatment. However, several challenges must be tackled for iPSC-based cell therapy to enter the market and achieve broader global adoption. This white paper, authored by the Japanese Society for Regenerative Medicine (JSRM) - International Society for Cell Therapy (ISCT) iPSC Committee delves into the hurdles encountered in the pursuit of safe and economically viable iPSC-based therapies, particularly from the standpoint of the cell therapy industry. It discusses differences in global guidelines and regulatory frameworks, outlines a series of quality control tests required to ensure the safety of the cell therapy, and provides details and important considerations around cost of goods (COGs), including the impact of automated advanced manufacturing.

Indexed as

Cell- and Tissue-Based TherapyInduced Pluripotent Stem CellsRegenerative MedicineHumansQuality Controlcritical quality attributes (CQAs)good manufacturing practice (cGMP)iPSC-derived cell therapiesquality by design (QbD)quality control (QC)regenerative medicinethe cost of goods (COGs)

Identifiers

PMID38958627
PMCPMC11471376

What OpenQuestion holds

Textmetadata
LicenceTDM
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.