This form must be completed for all recipients of cellular therapy (non-HCT) with or without a prior HCT. Recipients of CAR T cells, donor lymphocyte infusions, tumor-infiltrating lymphocytes, cytotoxic T cells are common cellular therapies that should be reported using this form. Regenerative medicine indications can only be reported using this form with the exception of genetic modified hematopoietic stem cells to treat hematologic or other non-malignant indications. These infusions are considered transplants and should be reported using the Pre-Transplant Essential Data (Pre-TED) Form 2400.

For recipients of hematopoietic cellular transplants (HCT), complete the Pre-TED (2400) and Disease Classification (2402) forms.

This form reflects baseline recipient data and indication for a course of cellular therapy. All cellular therapies (non-HCT) are collected on this form, including indications that reflect donor cellular infusions (DCI/DLI) done post-transplant, now referred to as “post-HCT cellular therapy”. A course of cellular therapy includes all infusions given per protocol, or when multiple infusions are given for the same indication using the same product/donor (e.g. post-HCT cellular therapy (DCI/DLI)).

Multiple infusions of commercially available products require a separate Pre-Cellular Therapy Essential Data (4000) forms for each infusion.

The use of cellular therapy is expanding. Treatment strategies include isolation and transfer of specific stem cell populations, administration of effector cells (e.g. cytotoxic T-cells), induction of mature cells to become pluripotent cells, and reprogramming of mature cells (e.g. CAR T-cells).

Figure 1. Disabled Edit Form Icon

Figure 2. Hovered Text, Consent Not Yet Reported

Links to sections of form:
Q1-17: Recipient Data
Q18-32: Cellular Therapy and HCT History
Q33-57: Product Identification
Q58-77: Indication for Cellular Therapy
Q78-84: Lymphodepleting Therapy Prior to Cellular Therapy
Q85-88: Toxicity Prophylaxis
Q89-99: Hematologic Findings Prior to Lymphodepleting Therapy
Q100-102: Functional Status
Q103-113: Comorbid Conditions

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 click here or reference the retired manual section on the Retired Forms Manuals webpage.

Date Manual Section Add/Remove/Modify Description
4/11/22 4000 Pre-CTED Add Clarification added on what to report if vaccine brand is Unknown: For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify in question 115. If the vaccine brand is unknown, leave the field blank and override the error as Unknown.
4/11/22 4000 Pre-CTED Add COVID-19 Vaccine blue box added above question 109: COVID-19 Vaccine
If the recipient received a COVID-19 vaccine at any time prior to July 2021 (before the COVID-19 vaccine questions were available on the Cellular Therapy Essential Data Pre-Infusion (4000) form), select Yes for question 109 at the first opportunity this form becomes available. When reporting the vaccine date, report the actual date the recipient received the vaccine.
4/11/22 4000 Pre-CTED Add Instruction added for documenting COVID-19 infections for subsequent infusion: Do NOT report an infection:
• A recipient has a positive antibody result. They do not have a history of positive COVID diagnostic results (PCR or antigen).
• The recipient was symptomatic and treated but COVID-19 diagnostic testing was not performed and/or COVID diagnostic testing was performed and negative.
DO report an infection:
• A recipient has a positive COVID diagnostic result (PCR or antigen). No treatment was given and/or recipient was asymptomatic.
7/23/2021 4000: Cellular Therapy Essential Data Pre-Infusion Modify Version 8 of the 4000: Cellular Therapy Essential Data Pre-Infusion section of the Forms Instruction Manual released. Version 8 corresponds to revision 8 of the Form 4000.
Last modified: Apr 11, 2022

Need more help with this?
Don’t hesitate to contact us here.

Was this helpful?

Yes No
You indicated this topic was not helpful to you ...
Could you please leave a comment telling us why? Thank you!
Thanks for your feedback.