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15 The statute defines minimal manipulation of HCTP products to mean (1) processing that does not alter the original relevant characteristics of the tissue relating to the tissues utility for reconstruction, repair, or replacement, and (2) for cells or non-structural tissues, processing that does not alter the relevant biological characteristics of cells or tissues

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[2] McCoy AT, Benoist CC, Wright JW, Kawas LH, Bule-Ghogare JM, Zhu M, Appleyard SM, Wayman GA, Harding JW

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