Evidence map›Paper›PMID 38920694›Full record

ArticleCells2024

Off-the-Shelf Cord-Blood Mesenchymal Stromal Cells: Production, Quality Control, and Clinical Use.

Tiziana Montemurro, Cristiana Lavazza, Elisa Montelatici, Silvia Budelli, Salvatore La Rosa, Mario Barilani, Cecilia Mei, Paolo Manzini, Ilaria Ratti, Silvia Cimoni and 7 more

Abstract read
In one paragraph

Article in Cells, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
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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

17 authors.

Tiziana MontemurroUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-1880-5347
Cristiana LavazzaUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-1167-6167
Elisa MontelaticiUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-0717-2695
Silvia BudelliUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-3111-1307
Salvatore La RosaUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0009-0007-5709-3956
Mario BarilaniUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0003-2225-897X
Cecilia MeiUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-8859-4557
Paolo ManziniUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0001-5934-2708
Ilaria RattiMilano Cord Blood Bank and Center of Transfusion Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0009-0009-1193-1197
Silvia CimoniMilano Cord Blood Bank and Center of Transfusion Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0009-0001-6309-8880
Manuela BrascaMilano Cord Blood Bank and Center of Transfusion Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0009-0001-9192-8028
Daniele PratiMilano Cord Blood Bank and Center of Transfusion Medicine, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.
Giorgia SaporitiBone Marrow Transplantation and Cellular Therapy Center, Hematology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-1492-6117
Giuseppe AstoriLaboratory of Advanced Cellular Therapies and Haematology Unit, San Bortolo Hospital, AULSS8 "Berica", 36100 Vicenza, Italy.ORCID 0000-0003-2794-5218
Francesca EliceLaboratory of Advanced Cellular Therapies and Haematology Unit, San Bortolo Hospital, AULSS8 "Berica", 36100 Vicenza, Italy.ORCID 0000-0002-5176-0064
Rosaria GiordanoUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-7263-0752
Lorenza LazzariUnit of Cellular and Gene Therapy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.ORCID 0000-0002-9434-4538

Funding

Fondazione Regionale per la Ricerca Biomedica CP2_10/2018Ricerca indipendente AIFA AIFA-2016- 02364896
6 · The paper itself

Abstract

Background Recently, mesenchymal stromal cells (MSCs) have gained recognition for their clinical utility in transplantation to induce tolerance and to improve/replace pharmacological immunosuppression. Cord blood (CB)-derived MSCs are particularly attractive for their immunological naivety and peculiar anti-inflammatory and anti-apoptotic properties.

objectivesThe objective of this study was to obtain an inventory of CB MSCs able to support large-scale advanced therapy medicinal product (ATMP)-based clinical trials. STUDY

designWe isolated MSCs by plastic adherence in a GMP-compliant culture system. We established a well-characterized master cell bank and expanded a working cell bank to generate batches of finished MSC(CB) products certified for clinical use. The MSC(CB) produced by our facility was used in approved clinical trials or for therapeutic use, following single-patient authorization as an immune-suppressant agent.

resultsWe show the feasibility of a well-defined MSC manufacturing process and describe the main indications for which the MSCs were employed. We delve into a regulatory framework governing advanced therapy medicinal products (ATMPs), emphasizing the need of stringent quality control and safety assessments. From March 2012 to June 2023, 263 of our Good Manufacturing Practice (GMP)-certified MSC(CB) preparations were administered as ATMPs in 40 subjects affected by Graft-vs.-Host Disease, nephrotic syndrome, or bronco-pulmonary dysplasia of the newborn. There was no infusion-related adverse event. No patient experienced any grade toxicity. Encouraging preliminary outcome results were reported. Clinical response was registered in the majority of patients treated under therapeutic use authorization.

conclusionsOur 10 years of experience with MSC(CB) described here provides valuable insights into the use of this innovative cell product in immune-mediated diseases.

Indexed as

Fetal BloodMesenchymal Stem CellsMesenchymal Stem Cell TransplantationQuality ControlAdolescentAdultAgedChildFemaleHumansMaleMiddle AgedYoung Adultcell therapyinnovative therapiesmesenchymal stromal cellstransplantationumbilical cord blood

Identifiers

PMID38920694
PMCPMC11202005

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Registered trials

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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.