Stem cell and cellular therapy developments.
- Authors
- Strong, Michael; Farrugia, Albert; Rebulla, Paolo
- Year
- 2009
- Journal
- Biologicals : journal of the International Association of Biological Standardization
- PMID
- 19231235
- DOI
- 10.1016/j.biologicals.2009.01.003
Recent discoveries on human and non-human stem cells have prompted the development of several studies aimed at the translation of laboratory evidences into novel clinical procedures collectively known as 'cellular therapy'. In this regard, a number of features specifically related to the clinical setting require stringent evaluation, including, but not limited to: ethical appropriateness; donor and recipient informed consent; autologous versus allogeneic use; media and devices for cell collection, processing, characterization, storage and distribution; donor and recipient adverse events registration and management; risk-to-benefit and cost analysis; outcome analysis; production sites accreditation and management; regulatory oversight. This article describes recent national and international developments related to the distribution of cells and tissues for clinical use. Moreover, an example is reported of the implementation of a cellular therapy production site compliant with good manufacturing practices (GMPs) in a large European University hospital.
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| Using human stem cells as a model system to understand the neural mechanisms of alcohol use disorders: Current status and outlook. | 2019 | 30087005 |
External
| Title | Authors | Journal | Year | Link |
|---|---|---|---|---|
| [<i>In vitro</i> study of bone morphogenetic protein 2 gelatin/chitosan hydrogel sustained-release system composite hydroxyapatite/zirconium dioxide foam ceramics and induced pluripotent stem cells derived mesenchymal stem cells]. | Chai L et al. | — | 2019 | → |
| Using human stem cells as a model system to understand the neural mechanisms of alcohol use disorders: Current status and outlook. | Scarnati MS et al. | — | 2019 | → |
| Multifunctional quantum dots-based cancer diagnostics and stem cell therapeutics for regenerative medicine. | Onoshima D et al. | — | 2015 | → |
| Isolation and characterization of the environmental bacterial and fungi contamination in a pharmaceutical unit of mesenchymal stem cell for clinical use. | Martín PG et al. | — | 2012 | → |
| A biological global positioning system: considerations for tracking stem cell behaviors in the whole body. | Li SC et al. | — | 2010 | → |
| Advances in reprogramming somatic cells to induced pluripotent stem cells. | Patel M et al. | — | 2010 | → |