The sections below provide instructions for completing the Cellular Therapy Essential Data Pre-Infusion Form (F4000), Cellular Therapy Product Form (F4003), Cellular Therapy Infusion Form (F4006), and Cellular Therapy Essential Data Follow-Up Form (F4100).
Below are scenarios describing when autologous cellular therapy data can be collected in the context of patient consent for research:
Cell therapy follow up schedule
As part of the Summer 2022 release, a reporting track will now be set for all cell therapy CRIDs reported to the CIBMTR. The track will be set by the center reporting preference and infusion type. There are five cellular therapy reporting tracks:
- 15 year
- 100 day only
- No follow up
See the Data Management Guide for a full description of each track.
Cell therapy reporting preferences:
As part of the Summer 2022 release, every center will have a reporting preference. The options are:
- Do Not Perform
- Perform Do Not Report
- Research Level
- Regulatory Level
Please see the Data Management Guide for a full description of the different levels, including which forms will come due.
Follow up tracks as set by reporting preference
As part of the Summer 2022 release, the center reporting preference is now used in determining the cell therapy reporting track, and subsequently which forms are required.
When to report cellular therapy infusions to the CIBMTR
Please see the Data Management Guide for a full description the guidance when determining whether to report a cellular therapy to the CIBMTR.
Donor cellular infusion (DCI)
Donor cellular infusions (DCIs) are a subtype of cellular therapy.
An infusion can be classified as a “DCI” when:
- The intent is something other than to restore hematopoiesis
- The infusion must be post-HCT, often by the same donor as the HCT
- Indication is suboptimal donor chimerism, immune reconstitution, GVHD treatment, prevent or treat disease relapse (as reported on F4000)
- Composition of cells include mesenchymal cells, peripheral blood mononuclear cells, NK cells, etc.
Donor Lymphocyte Infusions (DLIs) are a subset of DCIs. DLIs meet the same criteria above but are infusions of just a lymphocyte product. DLIs are reported on the Donor Lymphocyte Infusion (2199) form.
|Date||Manual Section||Add/Remove/Modify||Description||Reasoning (If applicable)|
|9/23/2022||4000: Cellular Therapy Essential Data Pre-Infusion||Modify||Version 9 of the Cellular Therapy Manuals section of the Forms Instruction Manual released.|
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