Evidence map›Paper›PMID 40462121›Full record

ArticleJournal of translational medicine2025

Clinical grade expansion protocol for the manufacture of thymus-derived Treg cells for clinical application.

Giorgia Fanelli, Philippa Marks, Apoorva Aiyengar, Marco Romano, Sakina Gooljar, Sandeep Kumar, Michael Burch, Giovanna Lombardi

Abstract read
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Article in Journal of translational medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

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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

8 authors.

Giorgia FanelliPeter Gorer Department of Immunobiology, School of Immunology and Microbial Sciences, King's College, London, UK. giorgia.fanelli@kcl.ac.uk.ORCID 0000-0002-2003-529X
Philippa MarksAdvanced Therapy Manufacturing (GMP) Unit Guy's, St Thomas' NHS Foundation Trust and King's College London Clinical Research Facility, London, UK.
Apoorva AiyengarDepartment of Cardiology, Great Ormond Street Hospital NHS Foundation Trust, London, UK.
Marco RomanoPeter Gorer Department of Immunobiology, School of Immunology and Microbial Sciences, King's College, London, UK.
Sakina GooljarAdvanced Therapy Manufacturing (GMP) Unit Guy's, St Thomas' NHS Foundation Trust and King's College London Clinical Research Facility, London, UK.
Sandeep KumarAdvanced Therapy Manufacturing (GMP) Unit Guy's, St Thomas' NHS Foundation Trust and King's College London Clinical Research Facility, London, UK.
Michael BurchDepartment of Cardiology, Great Ormond Street Hospital NHS Foundation Trust, London, UK.
Giovanna LombardiPeter Gorer Department of Immunobiology, School of Immunology and Microbial Sciences, King's College, London, UK.

Funding

British Heart Foundation TA/F/21/210034
6 · The paper itself

Abstract

backgroundAdoptive transfer of regulatory T cells (Tregs) has provided promising results in treating autoimmune disorders, transplant rejection and graft versus-host disease in early clinical trials. However, major challenges remain for developing a standardized and robust good manufacturing practice (GMP)-compliant cell product which is severely hampered by low frequency of Tregs in circulation and laborious ex vivo expansion.

methodsPaediatric thymuses routinely obtained during heart surgery have been shown by us and others to be a valuable source of large numbers of pure Tregs (Thy-Tregs). Here we show results from our process development approach including systematic laboratory-scale testing of activation reagents, restimulation timing, and cryopreservation to translate our expansion protocol of Thy-Tregs into a clinical grade cell product.

resultsThy-Tregs obtained through CD8

conclusionThis process has proved the capability of efficiently producing high number of functional Thy-Tregs, which will be administered as cell therapy in children undergoing heart transplantation (ATT-Heart, ISRCTN15374803), and enhancing the potential of using expanded Thy-Tregs for broad-ranging therapeutic applications.

Indexed as

Cell Culture TechniquesThymus GlandT-Lymphocytes, RegulatoryCell ProliferationChildCryopreservationHumansClinical trialGMPImmuno-therapyThy-Tregs

Identifiers

PMID40462121
PMCPMC12131477

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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.