2003: Gene Therapy Product

This form must be completed for all products for Gene Therapy recipients. All patients receiving a Gene Therapy product will be placed into the CRF track. For TED only reporting centers, Form 2003 will also need to be completed.

The Gene Therapy Product (2003) form is designed to capture product specific information for all infusions given to a recipient as a course of gene therapy. PBSC collected from a single mobilization event (a mobilization event is the 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 2003 form.

For more information see Appendix D – How To Distinguish Infusion Types and Appendix E – Definition of a Product.

Links to Sections of Form:
Q1 – 5: Product Identification
Q6 – 12 : Product Collection
Q13 – 29: Product Processing / Manipulation
Q30 – 68: Product Analysis
Q69 – 75: Product Infusion

Manual Updates:
Sections of the Forms Instruction Manual are frequently updated. The most recent updates to the manual can be found below. For additional information, select the manual section and review the updated text.

If you need to reference the historical Manual Change History for this form, please reference the retired manual section on the Retired Forms Manuals of the CIBMTR Forms Instruction Manual is intended to be a resource for completing the Gene Therapy Product Form.

Date	Manual Section	Add/Remove/Modify	Description
12/18/2023	2003: Gene Therapy Product	Add	Bone Marrow Products blue information box added above Q6: 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.
10/29/2021	2003: Gene Therapy Product	Add	Version 1 of the 2003: Gene Therapy Product section of the Forms Instructions Manual released. Version 1 corresponds to revision 1 of the Form 2003.

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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.