Friday, January 07, 2005

FDA/Patient Correspondence: Notes & Comments

Note 1: the FDA considers cord blood cells to be the same as hematopoietic stem cells.

Note 2: Cord blood cells are not subject to FDA pre-market review or approval.

Note 3: Cord Blood is not approved for any specific use.

Note 4: FDA “IND” authorization is not required for cord blood, or cord blood stem cells provided the cells are only minimally manipulated prior to use.

Comment 1: If cord blood is not subject to FDA pre-market approval or review, then the FDA has no business concerning itself in this matter, or inhibiting qualified medical practitioners from using cord blood in treating patients.

Comment 2: Cord blood can not be approved for any specific use, since it’s not subject to pre-market review or approval. For the same reason, nor can it be barred from specific uses.

Comment 3:An IND is required when using cord blood stem cells that have been more than minimally manipulated prior to use. However, this does not apply to the present case, as the patients were receiving transfusions of whole, untreated cord blood.

The following slides present an inquiry by U.S. Senator Joseph Lieberman (D-CT) into FDA actions that blocked ALS patient access to cord blood transfusions.


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