Q7 -15: Product Collection

*Multiple collections versus multiple products
The Gene Therapy Product (2003) form collects the information for a single product. PBSC cells collected from a single mobilization event (a mobilization event is a planned administration of growth factors or systemic therapy designed to enhance stem cell collection), even when collected over several days, is considered one product. Multiple products are collected when, for example, the donor requires another mobilization to collect a product at a later date. The collection from the second mobilization event is considered a different product and should be reported on an additional Gene Therapy Product (2003) form.

*Bone Marrow Products
If the Gene Therapy product is mobilized from the bone marrow, select Not done for the questions Peripheral blood CD34+ cell count prior to first dose of cytokine for mobilization (baseline) and Peripheral blood CD34+ cell count on Day 1 apheresis, just prior to start of procedure.

Questions 7 – 8 Peripheral blood CD34+ cell count prior to first dose of cytokine for mobilization (baseline)

The recipient’s peripheral blood CD34+ cell count is often determined prior to the start of mobilization as it may predict success of PBSC mobilization.

Indicate if the peripheral CD34+ cell count was performed prior to the first dose of cytokine for mobilization (baseline). If Done, report the CD34+ cell count at baseline per microliter (uL) or cubic millimeter (mm³).

Questions 9 – 10 Peripheral blood CD34+ cell count on Day 1 apheresis, just prior to start of procedure.

Indicate if the peripheral blood CD34+ count was performed just prior to connecting the recipient to the apheresis machine. If Done report the CD34+ cell count per microliter (uL) or cubic millimeter (mm³).

When reporting this value, review the apheresis start time to ensure the CD34+ cell count was performed prior to the start of the procedure.

Question 11: Date of first collection for this mobilization

Report the first date (YYYY-MM-DD) the gene therapy cell collection was performed. If the collection event occurred over multiple days, enter the date the collection started (i.e. Day 1)

Example 1: An autologous recipient was mobilized with G-CSF and underwent a two-day PBSC collection. Since the collection and mobilization methods remained the same over the duration of the collection, this collection is considered one product. Report the collection start date as the date of product collection.
Example 2: An autologous recipient was mobilized with G-CSF and underwent a two-day PBSC collection. The collected cell counts were poor, and no further collections were attempted. One week later the recipient was re-mobilized with G-CSF and a second PBSC collection was performed. Due to the recipient having two mobilization events, this is considered two separate products. The date of first collection should be the first day of collection for the product for which the form is being completed.

Question 12-13: What agents were used to mobilize the recipient for this HCT? (check all that apply)

Specify the agents used in the mobilization event(s).

• G-CSF: granulocyte colony-stimulating factor, TBO-filgrastim, filgrastim, Granix®, Neupogen®
• GM-CSF: sargrmostim, Leukine®
• Pegylated G-CSF: pegfilgrastim, Neulasta®
• Motixafortide: Aphexda®
• Perlixafor: Mozobil®
• Combined with chemotherapy: Systemic therapies used to enhance the stem cell product may include cyclophosphamide or ICE chemotherapy (Ifosfamide, carboplatin, and etoposide) with or without rituximab.
• Anti-CD20: rituximab, Rituxan®
• Other agent: If an agent was used but not listed above, select Other agent and specify.
  

Questions 14 – 15: Was more than one collection required?

If more than one day of collection was required for this mobilization event, select Yes, and report the total number of subsequent days of collection. Do not report days of collection for a different product as each product is reported on a separate Gene Therapy Product (2003) form.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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