Publication

Biological characterization of a human mesenchymal stromal cell product

Creane, Michael
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Identifiers
http://hdl.handle.net/10379/6081
 https://doi.org/10.13025/16931
Publication Date
2016-07-21
Keywords
Mesenchymal stromal cells, Stem cell clinical trials, Toxicology, Biodistribution, Potency testing, Angiogenesis, Preclinical, Regenerative medicine
Type
Thesis
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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.
Funder
Science Foundation Ireland
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Rights
Attribution-NonCommercial-NoDerivs 3.0 Ireland
cbn
Collections
University of Galway Theses (PhD Theses)