Biological characterization of a human mesenchymal stromal cell product
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Date
2016-07-21Author
Creane, Michael
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Abstract
The translation of stem cell research into a therapeutic setting presents with it many scientific, logistic, financial and regulatory challenges for academic scientists. This thesis identifies some key areas that one must consider in the development of a cell therapy product intended for testing in humans. The data described herein formed the preclinical safety package of an investigator brochure that was submitted to the Health Products Regulatory Authority to support the clinical testing of a mesenchymal stromal cell product in ‘no option for revascularization’ critical limb ischaemia patients.