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Table 2 Key definitions (Canada)

From: Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials

Safety of Human Cells, Tissues and Organs (CTO) for Transplantation Regulations, Article 1

Homologous in respect of a cell, tissue or organ, means that the cell, tissue or organ performs the same basic function after transplantation.

Minimally manipulated means

(a) In respect of a structural tissue, that the processing does not alter the original characteristics that are relevant to its claimed utility for reconstruction, repair or replacement; and

(b) In respect of cells and non-structural tissue, that the processing does not alter the biological characteristics that are relevant to their claimed utility.

Food and Drugs Act, Article 2

Drug includes any substance or mixture of substances manufactured, sold or represented for use in

(a) The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms in human beings or animals,

(b) Restoring, correcting or modifying organic functions in human beings or animals, or

(c) Disinfection in premises in which food is manufactured, prepared or kept.

[emphasis added by the authors]