Evidence map›Paper›PMID 25122690›Full record

ArticleStem cells translational medicine2014

Cost-effective master cell bank validation of multiple clinical-grade human pluripotent stem cell lines from a single donor.

Liani Devito, Anastasia Petrova, Cristian Miere, Stefano Codognotto, Nicola Blakely, Archie Lovatt, Caroline Ogilvie, Yacoub Khalaf, Dusko Ilic

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Stem cells translational medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.6field-weighted citation impact, top 17% 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

14 citing papers in PubMed, 24 citations in OpenAlex.

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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

9 authors at 2 institutions in 1 country.

Liani DevitoDivision of Women's Health, Women's Health Academic Centre, King's College London, London, United Kingdom;
Anastasia PetrovaDivision of Women's Health, Women's Health Academic Centre, King's College London, London, United Kingdom;
Cristian MiereDivision of Women's Health, Women's Health Academic Centre, King's College London, London, United Kingdom;
Stefano CodognottoDivision of Women's Health, Women's Health Academic Centre, King's College London, London, United Kingdom; St8Biologics, QA Consultancy, London, United Kingdom;
Nicola BlakelySGS Vitrology Ltd., Glasgow, United Kingdom;
Archie LovattSGS Vitrology Ltd., Glasgow, United Kingdom;
Caroline OgilvieGuy's & St. Thomas' Centre for Preimplantation Genetic Diagnosis and Genetics Centre and.
Yacoub KhalafDivision of Women's Health, Women's Health Academic Centre, King's College London, London, United Kingdom; Assisted Conception Unit, Guy's & St. Thomas' National Health Services Foundation Trust, London, United Kingdom.
Dusko IlicDivision of Women's Health, Women's Health Academic Centre, King's College London, London, United Kingdom; dusko.ilic@kcl.ac.uk.
King's College London · GBGuy's and St Thomas' NHS Foundation Trust · GB

Funding

Medical Research Council G0701172Medical Research Council g0801061Medical Research Council G0801061
6 · The paper itself

Abstract

Standardization guidelines for human pluripotent stem cells are still very broadly defined, despite ongoing clinical trials in the U.S., U.K., and Japan. The requirements for validation of human embryonic (hESCs) and induced pluripotent stem cells (iPSCs) in general follow the regulations for other clinically compliant biologics already in place but without addressing key differences between cell types or final products. In order to realize the full potential of stem cell therapy, validation criteria, methodology, and, most importantly, strategy, should address the shortfalls and efficiency of current approaches; without this, hESC- and, especially, iPSC-based therapy will not be able to compete with other technologies in a cost-efficient way. We addressed the protocols for testing cell lines for human viral pathogens and propose a novel strategy that would significantly reduce costs. It is highly unlikely that the multiple cell lines derived in parallel from a tissue sample taken from one donor would have different profiles of endogenous viral pathogens; we therefore argue that samples from the Master Cell Banks of sibling lines could be safely pooled for validation. We illustrate this approach with tiered validation of two sibling clinical-grade hESC lines, KCL033 and KCL034 (stage 1, sterility; stage 2, specific human pathogens; and stage 3, nonspecific human pathogens). The results of all tests were negative. This cost-effective strategy could also be applied for validation of Master Cell Banks of multiple clinical-grade iPSC lines derived from a single donor.

Indexed as

Pluripotent Stem CellsCell LineHumansReal-Time Polymerase Chain ReactionTissue BanksClinical-grade human embryonic stem cell linesClinical-grade iPS cell linesCurrent good manufacturing practiceHuman viral pathogensMaster cell bankValidation

Identifiers

PMID25122690
PMCPMC4181394
OpenAlexW2058459663

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.