Questions 11-12: Specify the method of product collection
Specify how the product was collected:
Apheresis/Leukapheresis: removal of blood to collect specific white blood cells (e.g., lymphocytes, CD34+ stem cells, etc.). Leukapheresis is a type of apheresis.
Bone marrow aspirate: a sample of liquid bone marrow is removed, usually from the hip bone, breastbone, or thigh bone.
Cord blood: a sample of blood from umbilical cord blood specimen. Cord blood is collected from the umbilical cord after a baby is born and is stored in a cord blood bank.
Peripheral blood draw: a sample of blood is removed from veins by venipuncture.
Tumor biopsy sample: sample taken from a biopsy.
If the product was collected by a method not listed above, select Other method and specify the other product collection method.
Question 13: Number of collections
Report the number of collections it took to collect the necessary cells for the for the cell therapy product.
If a collection occurs, but results in insufficient volume or poor quality for product manufacturing, do not report the date or count it as part of the number of collections reported
Example 1. A collection is performed March 1st but has a suboptimal yield and is discarded. A second collection is performed March 4th resulting in a product that is used for infusion.
What to report: Report only 1 collection (only the second collection is reported)
Example 2. A collection is performed March 1st but has a suboptimal yield but has acceptable quality. A second collection is performed March 4th and the two are combined to use for a single product.
What to report: Report 2 collections (both collections are reported)
Section Updates:
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