ArticleStem cells and development2014
Standard requirement of a microbiological quality control program for the manufacture of human mesenchymal stem cells for clinical use.
Article in Stem cells and development, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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.
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.
- Article
- Body Fluid-Derived Stem Cells: Powering Innovative, Less-Invasive Cell Therapies.International journal of molecular sciences · 2025Review
- Advanced function, design and application of skin substitutes for skin regeneration.Materials today. Bio · 2024Review
- Hypothermic Storage of 3D Cultured Multipotent Mesenchymal Stromal Cells for Regenerative Medicine Applications.Polymers · 2022Article
- Standard toxicity study of clinical-grade allogeneic human bone marrow-derived clonal mesenchymal stromal cells.Stem cell research & therapy · 2022Article
- An open-label phase 1 clinical trial of the allogeneic side population adipose-derived mesenchymal stem cells in SMA type 1 patients.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022Article
- An overview of mesenchymal stem cells and their potential therapeutic benefits in cancer therapy.Oncology letters · 2021Review
- Manufacturing and banking canine adipose-derived mesenchymal stem cells for veterinary clinical application.BMC veterinary research · 2021Article
- Therapeutic Mesenchymal Stem/Stromal Cells: Value, Challenges and Optimization.Frontiers in cell and developmental biology · 2021Review
- Principal Criteria for Evaluating the Quality, Safety and Efficacy of hMSC-Based Products in Clinical Practice: Current Approaches and Challenges.Pharmaceutics · 2019Review
- Clinically Relevant Solution for the Hypothermic Storage and Transportation of Human Multipotent Mesenchymal Stromal Cells.Stem cells international · 2019Article
- [Advanced medicinal products medical therapy based on mesenchymal stem cells].Farmacja polska · 2018Article
- Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production.Stem cells international · 2018Article
- Mesenchymal Stromal Cells: From Discovery to Manufacturing and Commercialization.Stem cells international · 2018Review
- Recent Advances in Tissue Engineering Strategies for the Treatment of Joint Damage.Current rheumatology reports · 2017Review
- Characterization of Human AB Serum for Mesenchymal Stromal Cell Expansion.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2017Article
- Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects.Stem cells international · 2016Review
- Human adipose tissue-derived stem cells cultured in xeno-free culture condition enhance c-MYC expression increasing proliferation but bypassing spontaneous cell transformation.Stem cell research & therapy · 2015Article
- Bottlenecks in the Efficient Use of Advanced Therapy Medicinal Products Based on Mesenchymal Stromal Cells.Stem cells international · 2015Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The manufacturing of human mesenchymal stem cells (hMSCs) as cell-based products for clinical use should be performed with appropriate controls that ensure its safety and quality. The use of hMSCs in cell therapy has increased considerably in the past few years. In line with this, the assessment and management of contamination risks by microbial agents that could affect the quality of cells and the safety of patients have to be considered. It is necessary to implant a quality control program (QCP) covering the entire procedure of the ex vivo expansion, from the source of cells, starting materials, and reagents, such as intermediate products, to the final cellular medicine. We defined a QCP to detect microbiological contamination during manufacturing of autologous hMSCs for clinical application. The methods used include sterility test, Gram stain, detection of mycoplasma, endotoxin assay, and microbiological monitoring in process according to the European Pharmacopoeia (Ph. Eur.) and each analytical technique was validated in accordance with three different cell cultures. Results showed no microbiological contamination in any phases of the cultures, meeting all the acceptance criteria for sterility test, detection of mycoplasma and endotoxin, and environmental and staff monitoring. Each analytical technique was validated demonstrating the sensitivity, limit of detection, and robustness of the method. The quality and safety of MSCs must be controlled to ensure their final use in patients. The evaluation of the proposed QCP revealed satisfactory results in order to standardize this procedure for clinical use of cells.
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Registered trials
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