4003: Cellular Therapy Product

This form must be completed for all products for recipients of non-HCT cellular therapy (including post-HCT DCI infusions). For recipients of hematopoietic cellular transplants (HCT), complete the Hematopoietic Stem Cell Transplant (HCT) Infusion (2006) form. For recipients of Donor Lymphocyte Infusions (DLI), complete the Donor Lymphocyte Infusion (2199) form.

The Cellular Therapy Product (4003) form is designed to capture product specific information for each product given to a recipient as part of a course of cellular therapy. A series of collections from the same donor that uses the same collection method, even if the collections are performed on different days, should be considered a single cellular therapy product if only one set of manufacturing steps are applied to the collected material. The Product Form is due within 45 days after infusion.

If more than one type of cellular therapy product is infused as part of a single course of cellular therapy, each product type must be analyzed and reported on a separate Cellular Therapy Product (4003) form. A product from the same donor undergoing different manufacturing steps or manipulations is considered different products if each product is infused separately and requires multiple Cellular Therapy Product (4003) forms.

However, if the cells underwent different manufacturing steps or manipulations and at the end of the manufacturing process were combined for a single infusion or administration, it will be considered a single product and it will require a single Cellular Therapy Product (4003) form.

*Commercially available products
Product specific reporting guides are available for Abecma®, Amtagvi®, Aucatzyl®, Breyanzi®, Carvykti® , Kymriah®, Tecartus®, Tecelra®, and Yescarta® on the CIBMTR Portal. The reporting guides contain product specific reporting instructions for completing CIBMTR cellular therapy forms.

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

Links to sections of form:
Q1: Cellular Therapy Product Identification
Q2-10: Cell Product Source
Q11-13: Collection Procedure
Q14-35: Cell Product Manipulation
Q36-42: Cell Product Analysis Q43: Product Infusion
Q43: 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.

To reference the historical Manual Change History for this form, review the retired manual section on the Retired Forms Manual webpage.

Section Updates:

Date of Change	Manual Section	Add/Remove/Modify	Description
1/23/2026	4003: Cellular Therapy Product	Add	Version 6 of the Cellular Therapy Product section of the Forms Instructions Manual released. Version 6 corresponds to revision 6 of the Form 4003.

Copyright © 2004-2026 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.