ArticlePloS one2012
GMP-compliant isolation and large-scale expansion of bone marrow-derived MSC.
Article in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 1 of them a synthesis that pooled it.
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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
88 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Intra-articular treatment of knee osteoarthritis: from anti-inflammatories to products of regenerative medicine.The Physician and sportsmedicine · 2016Pooled it
- Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial.Stem cell research & therapy · 2018Trial
- Mesenchymal stem cells and conditioned media in the treatment of multiple sclerosis patients: Clinical, ophthalmological and radiological assessments of safety and efficacy.CNS neuroscience & therapeutics · 2017Trial
- Intra-articular injection of two different doses of autologous bone marrow mesenchymal stem cells versus hyaluronic acid in the treatment of knee osteoarthritis: multicenter randomized controlled clinical trial (phase I/II).Journal of translational medicine · 2016Trial
- Validated methods for isolation and qualification of mesenchymal stromal/stem cells from different sources.Journal of translational medicine · 2025Review
- The immunological pathogenesis of vitiligo and the potential role of mesenchymal stromal/stem cells in its treatment.Journal of translational medicine · 2025Review
- Quality by design strategy of human mesenchymal stem/stromal cell drug products for the treatment of knee osteoarthritis.World journal of stem cells · 2025Review
- Immunomodulatory and cardio-protective effects of differentially originated multipotent mesenchymal stroma cells during polymicrobial sepsis in mice.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025Article
- Emerging role of mesenchymal stem cell-derived exosomes in the repair of acute kidney injury.World journal of stem cells · 2025Review
- Automated Manufacturing Processes and Platforms for Large-scale Production of Clinical-grade Mesenchymal Stem/ Stromal Cells.Stem cell reviews and reports · 2025Review
- GMP Compliant Production of Therapeutic Components of Autologous Adipose Tissue.Methods in molecular biology (Clifton, N.J.) · 2025Article
- Fully Defined 3D Hybrid System for Bone Tissue Engineering: Integration of MeHA-RGD/PCL-TCP Scaffolds With Human Stem Cells via 3D-Printed Vacuum-Assisted Cell Loading Device.Journal of tissue engineering and regenerative medicine · 2025Article
- Evaluation of the impact of customized serum-free culture medium on the production of clinical-grade human umbilical cord mesenchymal stem cells: insights for future clinical applications.Stem cell research & therapy · 2024Article
- Role of Adipose-Derived Mesenchymal Stem Cells in Bone Regeneration.International journal of molecular sciences · 2024Review
- Insights into the role of mesenchymal stem cells in cutaneous medical aesthetics: from basics to clinics.Stem cell research & therapy · 2024Review
- Towards Stem Cell Therapy for Critical-Sized Segmental Bone Defects: Current Trends and Challenges on the Path to Clinical Translation.Journal of functional biomaterials · 2024Review
- Minor salivary gland stem cells: a comparative study of the biological properties under clinical-grade culture conditions.Cell and tissue research · 2023Article
- Tracking Targets of Dynamic Super-EnhancersEnvironmental health perspectives · 2023Article
- Identifying Biomarkers for Osteogenic Potency Assay Development.Advances in experimental medicine and biology · 2023Article
- A novel approach for large-scale manufacturing of small extracellular vesicles from bone marrow-derived mesenchymal stromal cells using a hollow fiber bioreactor.Frontiers in bioengineering and biotechnology · 2023Article
28 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMesenchymal stromal cells (MSC) have gained importance in tissue repair, tissue engineering and in immunosupressive therapy during the last years. Due to the limited availability of MSC in the bone marrow, ex vivo amplification prior to clinical application is requisite to obtain therapeutic applicable cell doses. Translation of preclinical into clinical-grade large-scale MSC expansion necessitates precise definition and standardization of all procedural parameters including cell seeding density, culture medium and cultivation devices. While xenogeneic additives such as fetal calf serum are still widely used for cell culture, its use in the clinical context is associated with many risks, such as prion and viral transmission or adverse immunological reactions against xenogeneic components. METHODS AND
findingsWe established animal-free expansion protocols using platelet lysate as medium supplement and thereby could confirm its safety and feasibility for large-scale MSC isolation and expansion. Five different GMP-compliant standardized protocols designed for the safe, reliable, efficient and economical isolation and expansion of MSC was performed and MSC obtained were analyzed for differentiation capacity by qPCR and histochemistry. Expression of standard MSC markers as defined by the International Society for Cellular Therapy as well as expression of additional MSC markers and of various chemokine and cytokine receptors was analysed by flow cytometry. Changes of metabolic markers and cytokines in the medium were addressed using the LUMINEX platform.
conclusionsThe five different systems for isolation and expansion of MSC described in this study are all suitable to produce at least 100 millions of MSC, which is commonly regarded as a single clinical dose. Final products are equal according to the minimal criteria for MSC defined by the ISCT. We showed that chemokine and integrin receptors analyzed had the same expression pattern, suggesting that MSC from either of the systems show equal characteristics of homing and adhesion.
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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.