ArticleDrug design, development and therapy2015
How we make cell therapy in Italy.
Article in Drug design, development and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- ATMP Environmental Exposure Assessment in European Healthcare Settings: A Systematic Review of the Literature.Frontiers in medicine · 2021Pooled it
- A decade of innovation in healthcare: Automation, bio-printing and digital twin technologies for personalized therapies.International journal of pharmaceutics: X · 2026Review
- A proposal of good manufacturing practices (GMP) laboratory for CAR T-cell therapy in Latin America and the Caribbean: challenges and opportunities.Frontiers in public health · 2026Review
- The clinical quality management system of advanced therapy medicinal products in the hospital setting: A scoping review.Molecular therapy. Methods & clinical development · 2025Review
- Article
- Off-the-Shelf Cord-Blood Mesenchymal Stromal Cells: Production, Quality Control, and Clinical Use.Cells · 2024Article
- First clinical application of cord blood mesenchymal stromal cells in children with multi-drug resistant nephrotic syndrome.Stem cell research & therapy · 2022Article
- Validation of an automated cell counting method for cGMP manufacturing of human induced pluripotent stem cells.Biotechnology reports (Amsterdam, Netherlands) · 2022Article
- Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product.Journal of translational medicine · 2022Article
- Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Review
- Safety and Effectiveness of Cell Therapy in Neurodegenerative Diseases: Take-Home Messages From a Pilot Feasibility Phase I Study of Progressive Supranuclear Palsy.Frontiers in neuroscience · 2021Article
- Gene therapy for chondral and osteochondral regeneration: is the future now?Cellular and molecular life sciences : CMLS · 2018Review
- Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production.Stem cells international · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the 21st century scenario, new therapeutic tools are needed to take up the social and medical challenge posed by the more and more frequent degenerative disorders and by the aging of population. The recent category of advanced therapy medicinal products has been created to comprise cellular, gene therapy, and tissue engineered products, as a new class of drugs. Their manufacture requires the same pharmaceutical framework as for conventional drugs and this means that industrial, large-scale manufacturing process has to be adapted to the peculiar characteristics of cell-containing products. Our hospital took up the challenge of this new path in the early 2000s; and herein we describe the approach we followed to set up a pharmaceutical-grade facility in a public hospital context, with the aim to share the solutions we found to make cell therapy compliant with the requirements for the production and the quality control of a high-standard medicinal product.
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Registered trials
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.