ArticleStem cells international2018
Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production.
Article in Stem cells international, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
What it found
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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.
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Who cites it
22 citing papers in PubMed.
- Validation of an automated total and viable cell counting for GMP-compliant production of human bone marrow stromal cells.Biotechnology reports (Amsterdam, Netherlands) · 2026Article
- Cord blood-derived mesenchymal stromal cells in children with steroid-dependent nephrotic syndrome: a prospective phase II study.Clinical kidney journal · 2026Article
- Standard Methods for Quality Control in Cell-Based Medicinal Products and their Validation for Clinical Applications.Advanced biomedical research · 2026Review
- Applications of Modern Cell Therapies: The Latest Data in Ophthalmology.Life (Basel, Switzerland) · 2025Review
- Article
- Definition of Synovial Mesenchymal Stem Cells for Meniscus Regeneration by the Mechanism of Action and General Amp1200 Gene Expression.International journal of molecular sciences · 2024Article
- Off-the-Shelf Cord-Blood Mesenchymal Stromal Cells: Production, Quality Control, and Clinical Use.Cells · 2024Article
- New characterization and safety evaluation of human limbal stem cells used in clinical application: fidelity of mitotic process and mitotic spindle morphologies.Stem cell research & therapy · 2023Article
- UPO Biobank: The Challenge of Integrating Biobanking into the Academic Environment to Support Translational Research.Journal of personalized medicine · 2023Article
- A novel glaucoma approach: Stem cell regeneration of the trabecular meshwork.Progress in retinal and eye research · 2022Review
- Mesenchymal Stromal Cell Mitochondrial Transfer as a Cell Rescue Strategy in Regenerative Medicine: A Review of Evidence in Preclinical Models.Stem cells translational medicine · 2022Review
- 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
- Stem Cell Therapy in Limb Ischemia: State-of-Art, Perspective, and Possible Impacts of Endometrial-Derived Stem Cells.Frontiers in cell and developmental biology · 2022Review
- 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
- Complete intra-laboratory validation of a LAL assay for bacterial endotoxin determination in EBV-specific cytotoxic T lymphocytes.Molecular therapy. Methods & clinical development · 2021Article
- Phenotype instability of hepatocyte-like cells produced by direct reprogramming of mesenchymal stromal cells.Stem cell research & therapy · 2020Article
- Standardized GMP-compliant scalable production of human pancreas organoids.Stem cell research & therapy · 2020Article
- Two Decades of Global Progress in Authorized Advanced Therapy Medicinal Products: An Emerging Revolution in Therapeutic Strategies.Frontiers in cell and developmental biology · 2020Review
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Mesenchymal stromal cells (MSC) for cellular therapy in European Union are classified as advanced therapy medicinal products (ATMPs), and their production must fulfill the requirements of Good Manufacturing Practice (GMP) rules. Despite their classification as medicinal products is already well recognized, there is still a lack of information and indications to validate methods and to adapt the noncompendial and compendial methods to these peculiar biological products with intrinsic characteristics that differentiate them from classic synthetic or biologic drugs. In the present paper, we present the results of the validation studies performed in the context of MSC development as ATMPs for clinical experimental use. Specifically, we describe the validation policies followed for sterility testing, endotoxins, adventitious viruses, cell count, and immunophenotyping. Our work demonstrates that it is possible to fully validate analytical methods also for ATMPs and that a risk-based approach can fill the gap between the prescription of the available guidelines shaped on traditional medicinal products and the peculiar characteristics of these novel and extremely promising new drugs.
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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.