2003: Gene Therapy Product

This form must be completed for each product infused for Gene Therapy recipients. 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. The form captures product identifiers, collection, processing/manipulation, and analysis details, as well as infusion detail.

A separate form should be completed for a single product. Examples of single products include:

• 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 mobilizations, and possibly multiple manufacturing steps, required for the final product intended for infusion. The number of mobilizations will be reported on the 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 – 6: Product Identification
Q7 – 15 : Product Collection
Q16 – 32: Product Processing / Manipulation
Q33 – 71: Product Analysis
Q72 – 81: 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
4/19/2025	2003: Gene Therapy Product	Modify	Definition of a gene therapy has been updated.
7/26/2024	2003: Gene Therapy Product	Add	Version 2 of the 2003: Gene Therapy Product section of the Forms Instructions Manual released. Version 2 corresponds to revision 2 of the Form 2003.

Copyright © 2004-2024 The Medical College of Wisconsin, Inc. and NMDP. All Rights Reserved.
CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.