ReviewFrontiers in pharmacology2023
Cell-based medicinal products approved in the European Union: current evidence and perspectives.
Review in Frontiers in pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Outlook of Cell Gene Therapies Development and Approval from Quality and Regulatory Perspective.Therapeutic innovation & regulatory science · 2026Pooled it
- Fracture healing: from molecular and cellular mechanisms to therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Manipulating embryogenesis and testing for potential: two real problems for the regulation of stem cell-based embryo models.Journal of medical ethics · 2026Article
- Advanced therapy medicinal product (ATMP) classification - a case study on spinal cord injury.Journal of translational medicine · 2026Review
- The PRO-CAR-T™ study: achieving excellence in patient and public involvement and engagement.Journal of patient-reported outcomes · 2026Article
- Why advanced therapy medicinal products struggle in clinical translation: an in-depth analysis of developmental challenges in the EU.Frontiers in medicine · 2026Review
- Bioprinted Constructs in the Regulatory Landscape: Current State and Future Perspectives.Advanced materials (Deerfield Beach, Fla.) · 2026Review
- Breakthrough for Anticancer Immunotherapy: Current Advances in Manufacturing Protocols of Chimeric Antigen Receptor-Based Therapies.Antibodies (Basel, Switzerland) · 2025Review
- 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
- Biomimetic Cell Membrane-Coated Scaffolds for Enhanced Tissue Regeneration.Advanced materials (Deerfield Beach, Fla.) · 2025Review
- Stem cell-derived gametes: what to expect when expecting their clinical introduction.Human reproduction (Oxford, England) · 2025Review
- Extracorporeal Photopheresis: Does It Have a Potential Place Among Cell-based Therapies?Transplantation direct · 2025Article
- Risk Minimisation Measures of Advanced Therapy Medicinal Products Authorised in the EU Between 2009 and 2023: A Cross-Sectional Study.Drug safety · 2025Article
- Intratumoral Delivery of Genetically Engineered Anti-IL-6 Trans-signaling Therapeutics.Molecular biotechnology · 2025Article
- The Potential of Mesenchymal Stem/Stromal Cells in Diabetic Wounds and Future Directions for Research and Therapy-Is It Time for Use in Everyday Practice?International journal of molecular sciences · 2024Review
- Prospects of Synergy: Local Interventions and CAR T Cell Therapy in Solid Tumors.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Efficacy of Platelet-Rich Plasma Intra-articular Injections in Hip and Knee Osteoarthritis.Cureus · 2024Review
- Mesenchymal Stromal Cell-Based Products: Challenges and Clinical Therapeutic Options.International journal of molecular sciences · 2024Review
- Human leucocytes processed by fast-rate inertial microfluidics retain conventional functional characteristics.Journal of the Royal Society, Interface · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Advanced Therapy Medicinal Products (ATMPs) are innovative clinical treatments exploiting the pharmacological, immunological, or metabolic properties of cells and/or gene(s) with the aim to restore, correct, or modify a biological function in the recipient. ATMPs are heterogeneous medicinal products, developed mainly as individualized and patient-specific treatments, and represent new opportunities for diseases characterized by a high-unmet medical need, including rare, genetic and neurodegenerative disorders, haematological malignancies, cancer, autoimmune, inflammatory and orthopaedic conditions. Into the European Union (EU) market, the first ATMP has been launched in 2009 and, to date, a total of 24 ATMPs have been approved. This review aims at reporting on current evidence of cell-based therapies authorized in the EU, including Somatic Cell Therapies, Tissue Engineering Products, and Cell-based Gene Therapy Products as Chimeric Antigen Receptor (CAR) T-cells, focusing on the evaluation of efficacy and safety in clinical trials and real-world settings. Despite cell-based therapy representing a substantial promise for patients with very limited treatment options, some limitations for its widespread use in the clinical setting remain, including restricted indications, highly complex manufacturing processes, elevated production costs, the lability of cellular products over time, and the potential safety concerns related to the intrinsic characteristics of living cells, including the risk of severe or life-threatening toxicities, such as CAR-T induced neurotoxicity and cytokine release syndrome (CRS). Although encouraging findings support the clinical use of ATMPs, additional data, comparative studies with a long-term follow-up, and wider real-world evidences are needed to provide further insights into their efficacy and safety profiles.
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.