ArticlePharmaceutical research2018
Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.
Article in Pharmaceutical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers.
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
12 citing papers in PubMed.
- Engineering high-fidelity bone organoids: Operational classification, multilineage crosstalk, biofabrication evidence, and translational validation.Materials today. Bio · 2026Article
- A roadmap for supporting the development of advanced therapy medicinal products in a European framework.The Lancet regional health. Europe · 2026Review
- Mitochondria-Targeted Biophysical Priming of Autologous Biologics for Skin Regeneration and Wound Repair.International journal of molecular sciences · 2026Review
- Insights on Clinical Development of Cell and Gene Therapy for Rare Diseases-by DahShu Innovative Design Scientific Working Group (IDSWG).Therapeutic innovation & regulatory science · 2025Review
- Safety Assessment of Stem Cell-Based Therapies: Current Standards and Advancing Frameworks.Cells · 2025Review
- An Efficient Probe-Based Quantitative PCR Assay Targeting Human-Specific DNA in ST6GALNAC3 for the Quantification of Human Cells in Preclinical Animal Models.Molecular biotechnology · 2025Article
- Development of Animal Models for Preclinical Safety Studies.Advances in experimental medicine and biology · 2025Review
- Current Advances and Future Perspectives on Mesenchymal Stem Cell-Derived Extracellular Vesicles in Alzheimer's Disease.Aging and disease · 2024Review
- Mesenchymal Stem Cells From Mouse Hair Follicles Reduce Hypertrophic Scarring in a Murine Wound Healing Model.Stem cell reviews and reports · 2022Article
- Mitigating Deficiencies in Evidence during Regulatory Assessments of Advanced Therapies: A Comparative Study with Other Biologicals.Molecular therapy. Methods & clinical development · 2020Article
- Commentary about mesenchymal stem cells and scarred vocal folds.Stem cell research & therapy · 2020Article
- Editorial to Theme Issue on Cell Based Therapeutics.Pharmaceutical research · 2019Article
Corrections and comments
- Erratum issued
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allogeneic, have been genetically modified, or not, or expanded ex vivo, and applied systemically or to an anatomical site different to that of their origin; comments applicable to one product may not be applicable to others, so bespoke development is needed, for all elements - quality, preclinical and clinical.
methodsAfter establishing how the product is produced, proof of potential for therapeutic efficacy, and then safety, of the product need to be determined. This includes understanding biodistribution, persistence and toxicity, including potential for malignant transformation. These elements need to be considered in the context of the intended clinical development.
resultsThis article describes regulatory mechanisms available to developers to support product development that aim to resolve scientific issues prior to marketing authorization application, to enable patients to have faster access to the product than would otherwise be the case.
conclusionsDevelopers are encouraged to be aware of both the scientific issues and regulatory mechanisms to ensure patients can be supplied with these products.
Indexed as
Identifiers
What OpenQuestion holds
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.