E

Glossary

Allogeneic: refers to cells or tissues from different individuals of the same species, but that are genetically different from each other.

Autologous: refers to cells or tissues derived from the same individual and are therefore genetically identical.

Clinical trial: any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s), and/or to study absorption, distribution, metabolism, and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.1

Efficacy (or therapeutic efficacy): the measure of the performance of a treatment for a given indication.

In vitro fertilization: combining eggs and sperm outside of the body with the goal of the sperm fertilizing (entering) the egg. The fertilized eggs (embryos) are then transferred to the uterus for implantation.

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1International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance Guideline for Good Clinical Practice. See http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf (accessed April 8, 2014).



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E Glossary Allogeneic: refers to cells or tissues from different individuals of the same species, but that are genetically different from each other. Autologous: refers to cells or tissues derived from the same individual and are therefore genetically identical. Clinical trial: any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s), and/or to study absorption, distribution, metabolism, and ex- cretion of one or more investigational medicinal product(s) with the ob- ject of ascertaining its (their) safety and/or efficacy.1 Efficacy (or therapeutic efficacy): the measure of the performance of a treatment for a given indication. In vitro fertilization: combining eggs and sperm outside of the body with the goal of the sperm fertilizing (entering) the egg. The fertilized eggs (embryos) are then transferred to the uterus for implantation. 1 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guidance for Industry E6 Good Clinical Practice: Consol- idated Guidance Guideline for Good Clinical Practice. See http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073122.pdf (accessed April 8, 2014). 85

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86 STEM CELL THERAPIES Institutional review board (IRB): a committee that reviews, approves, and monitors biomedical research involving human subjects for the pur- pose of protecting the rights and welfare of participants.2 Medical tourism: the act of traveling across borders to seek medical treatment. Mesenchymal stem cells: multipotent cells that can differentiate into bone (osteocytes), cartilage (chondrocytes), fat (adipocytes), and possi- bly other cells.3 Minimally manipulated: the processing of cells in a way that does not alter their relevant biological characteristics.4 Nutraceutical: an ingestible foodstuff that is purported to impart health or medicinal benefit. Pluripotency: the cellular characteristic of being able to differentiate into all specialized cell types. Regenerative medicine: an area of biomedical research focused on de- veloping treatments for the repair, replacement, or regeneration of dam- aged cells, tissues, or organs. Regulatory science: the development and use of new tools, standards and approaches to more efficiently develop products and to more effec- tively evaluate product safety, efficacy, and quality.5 Stem cell: a general term for cells that have the ability to self-renew and differentiate into a variety of mature specialized cell types. 2 FDA Regulatory Information. See http://www.fda.gov/regulatoryinformation/guidances/ ucm126420.htm (accessed April 8, 2014). 3 Also known as multipotent stromal cells, there is controversy over whether these are actually stem cells, including whether they can perpetually self-renew and differentiate. 4 FDA CFR—Code of Federal Regulations Title 21 revised 2013. See http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=1271.3 (accessed April 7, 2014). 5 FDA News and Events. See http://www.fda/gov/NewsEvents/Newsroom/PressAnnounce ments/ucm201706.htm (accessed April 8, 2014).

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APPENDIX E 87 Stem cell tourism: a type of medical tourism whereby a patient travels across borders to seek stem cell therapies to treat or cure disease.

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