The Food and Drug Administration (FDA) issued on January 16, 2007, a draft guidance recommending a streamlined path to licensure for establishments that manufacture cord blood for certain medical conditions. Placental/umbilical cord blood is a rich source of precursor cells capable of differentiating into mature blood cells. These precursor cells are known as hematopoietic stem/progenitor cells and can be used to replenish the bone marrow in patients with blood-based malignancies such as leukemia. The draft guidance describes FDA’s regulatory approach to the regulation of cord blood hematopoietic stem/progenitor cells that are:

• minimally manipulated (processing does not alter the original characteristics of the cells);
• used to replenish the bone marrow in patients with blood-related malignancies; and,
• used in recipients unrelated to the donor of the stem cells.

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