This section applies to Autologous products only. If this was an allogeneic product, continue with the “Cell Product Manipulation” section.

Question 13-14: Specify the method of product collection:

Specify how the product was collected:

Bone marrow aspirate: a sample of liquid bone marrow is removed, usually from the hip bone, breastbone, or thigh bone.

Leukapheresis: removal of blood to collect specific white blood cells (e.g., lymphocytes, CD34+ stem cells, etc.).

Bioptic sample: sample taken from a biopsy, typically a tumor biopsy

If the product was collected by a method not listed above, select Other method and specify the other product collection method in question 14.

Question 15: Number of collections

Report the number of collections it took to collect the necessary cells for the for the autologous 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 will be 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 will be reported)

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
. . . . .
Last modified: Jul 23, 2021

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