Evidence map›Paper›PMID 42785305›Full record

SynthesisStem cell reports2026

Quality control and non-clinical testing of iPSC- and ESC-derived medicinal products: A systematic review.

Akvilė Gasiūnaitė, Mara Tihaya, Inge van Amerongen-Westra, Fong Lin, Pema Gurung, Bahareh Rajaei, Eelco de Koning, Françoise Carlotti, Pauline Meij

Abstract readSystematic Review
In one paragraph

Synthesis in Stem cell reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Akvilė GasiūnaitėCenter for Cell and Gene Therapy, Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.
Mara TihayaCenter for Cell and Gene Therapy, Leiden University Medical Center, Leiden, the Netherlands.
Inge van Amerongen-WestraCenter for Cell and Gene Therapy, Leiden University Medical Center, Leiden, the Netherlands.
Fong LinCenter for Cell and Gene Therapy, Leiden University Medical Center, Leiden, the Netherlands.
Pema GurungWalaeus Library, Leiden University Medical Center, Leiden, the Netherlands.
Bahareh RajaeiDepartment of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.
Eelco de KoningDepartment of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.
Françoise CarlottiDepartment of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.
Pauline MeijCenter for Cell and Gene Therapy, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: p.meij@lumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The lack of specific resources for quality control (QC) and non-clinical testing of cell-based medicinal products derived from embryonic and induced pluripotent stem cells (PSCs) contributes to uncertainty, variability, and delay in devising testing strategies. We conducted a systematic review on testing practices for diverse PSC-derived medicinal products using a custom-made ranking system, compiling a comprehensive "QC menu" of relevant critical quality attributes, established fit-for-purpose and promising techniques, and study designs for product development or clinical release. This consolidated resource could benefit product developers and regulators by creating informative testing strategies, ultimately increasing harmonization, facilitating clinical translation, and ensuring patient safety.

Indexed as

Embryonic Stem CellsInduced Pluripotent Stem CellsAnimalsHumansQuality ControlRegenerative Medicinecell therapycharacterizationembryonic stem cellsinduced pluripotent stem cellsnon-clinical testingquality controlregenerative medicinerelease testingsafety and efficacysystematic review

Identifiers

PMID42785305
PMCPMC13681315

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.