Evidence map›Paper›PMID 42587814›Full record

ReviewCells2026

Genetically Modified MSCs for Targeted Regeneration: Balancing Efficacy, Biosafety, and GMP Standardization.

Kristina V Kitaeva, Ivan Y Filin, Albert A Rizvanov, Shahlo Turdikulova, Mirakbar Yakubov, Oksana Charishnikova, Valeriya V Solovyeva

Abstract readReview
In one paragraph

Review in Cells, 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

7 authors.

Kristina V KitaevaInstitute of Fundamental Medicine and Biology, Kazan Federal University, 420008 Kazan, Russia.ORCID 0000-0002-0704-8141
Ivan Y FilinInstitute of Fundamental Medicine and Biology, Kazan Federal University, 420008 Kazan, Russia.ORCID 0000-0002-3661-0527
Albert A RizvanovInstitute of Fundamental Medicine and Biology, Kazan Federal University, 420008 Kazan, Russia.ORCID 0000-0002-9427-5739
Shahlo TurdikulovaCenter for Advanced Technologies, Academy of Sciences of the Republic of Uzbekistan, Tashkent 100174, Uzbekistan.ORCID 0000-0003-0764-2332
Mirakbar YakubovCenter for Advanced Technologies, Academy of Sciences of the Republic of Uzbekistan, Tashkent 100174, Uzbekistan.ORCID 0000-0003-2928-8805
Oksana CharishnikovaCenter for Advanced Technologies, Academy of Sciences of the Republic of Uzbekistan, Tashkent 100174, Uzbekistan.ORCID 0000-0003-2317-3580
Valeriya V SolovyevaInstitute of Fundamental Medicine and Biology, Kazan Federal University, 420008 Kazan, Russia.ORCID 0000-0002-8776-3662

Funding

Tatarstan Academy of Sciences Agreement No. 12/2025-PD-KFU dated December 22, 2025
6 · The paper itself

Abstract

Mesenchymal stromal cells (MSCs) are a versatile platform for regenerative medicine and gene delivery because they combine multipotency, immunoregulatory activity, and injury-directed trafficking. Translation is nevertheless limited by donor- and tissue-dependent heterogeneity, variable biodistribution, and engineering-related risks. This review evaluates genetically modified MSCs as medicinal products rather than as a general MSC class. We compare self-inactivating lentiviral (SIN-LV) transduction, which provides efficient and durable expression and has limited early clinical experience, with targeted genome editing, which can define the integration locus and copy number but remains constrained by variable precise knock-in efficiency, off-target and double-strand-break-associated effects, manufacturing cost, and the absence of long-term clinical safety data. We integrate preclinical and clinical evidence with GMP-compatible manufacturing, potency testing, genomic surveillance, and release criteria. Particular attention is given to safe-harbor integration and B2M/CIITA-based hypoimmunogenic designs as strategies to reduce engineering-related batch variability and HLA-dependent donor variability. Together, these developments support a transition from empirically optimized MSC preparations toward molecularly defined cellular medicines with predefined genotype, expression, potency, and safety attributes.

Indexed as

Mesenchymal Stem CellsMesenchymal Stem Cell TransplantationRegenerationRegenerative MedicineAnimalsHumansLentivirusReference Standardsgenetically modified MSCsgenome editingGMPhypoimmunogenic MSCslentiviral vectorsmesenchymal stromal cellssafe-harbor integration

Identifiers

PMID42587814
PMCPMC13464713

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.