Regenerative and stem cell therapy practices part 6

Stem cell 2

 

Minimal manipulation:

(minor processing including purification, centrifugation, washing, preservation, storage)-the Food and Drug Administration (FDA) argues that it has the authority to regulate anything beyond minimal manipulation and homologous use:

  • For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement
  • For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues

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