2006: Hematopoietic Stem Cell Transplant (HCT) Infusion

Centers must complete the Form 2006 for each product when the recipient is assigned to the Comprehensive Report Form track. Centers must also complete the Form 2006 for the following product types when the recipient is assigned to the Transplant Essential Data track:

• NMDP donor products
• NMDP and non-NMDP cord blood units
• Any product co-infused with a cord blood unit

Additionally, all transplant centers (TED-only and Comprehensive Report Form) participating in the Related Sample Repository must complete the Form 2006 for all non-NMDP donor products when a research sample is collected.

For more information see General Instructions, Center Type and Data Collection Forms.

The Form 2006 is designed to capture product- and infusion-specific information for all products given to a recipient as part of a Hematopoietic Stem Cell Transplant (HCT). This includes cells given prior to the HCT for reasons other than engraftment. In addition to use in research, this information is used for quality assurance measures, both by the NMDP and the Cord Blood Banks.

If more than one type of HCT product is infused, each product type must be analyzed and reported on a separate form. For example, the scenarios below require two 2006 forms, one for each product:

• Two different products from the same donor (i.e., PBSC and bone marrow)
• A co-infusion of two products (i.e., haplo donor PBSC and CBU)

However, a series of collections from the same donor that uses the same collection method and mobilization cycle, even if the collections are performed on different days, should be considered a single product.

For more information see Appendix D and Appendix E.

Q1-3: Pre-Collection Therapy
Q4-7: Product Collection
Q8-21: Product Transport and Receipt
Q22-40: Product Processing/Manipulation
Q41-91: Product Analysis
Q92-141: Product Infusion
Q142-168: Donor/Infant Demographic Information

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
7/26/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	Product Analysis Timepoints red warning box modified above Q41: Prior revisions of the HCT Product and Infusion (2006) Form (Revisions 1-4) have asked for product analysis values at multiple timepoints. In the new revision of the form, only the “At Infusion” timepoint is required for all product types., except cord blood units (CBUs). For CBUs, an additional both the “At Infusion” and “At Arrival” timepoint-s- should be reported if the CBU was analyzed prior to the product wash. are required.
7/26/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	Instruction for reporting timepoints for CBUs updated: For all products, the “at infusion” timepoint must be reported. The “at infusion” timepoint should only report the values for the actual product volume infused. The At Infusion timepoint should include values reflective of the product infused regardless of when the analysis occurred. Since all products are analyzed prior to cryopreservation, the At Infusion timepoint would be applicable for these cell counts. Depending on the product type and your center’s practice, viability may be assessed closer to the time of infusion. For cord blood units, both a ‘product arrival’ and an ‘at infusion’ timepoint must be reported. an “At Arrival” timepoint should be reported if the center performed an analysis prior to the CBU wash. An “At Infusion” timepoint must be reported and should reflect the product analysis performed post wash.
7/26/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Orca Bio Products and Donor Information blue box added above Q34
7/26/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Remove	Omidubicel and Orca T Products blue box updated above Q34 and 35 to clarify these instructions are only applicable for Omidubicel
3/8/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Omidubicel and Orca-T Products blue box added above Q35: Omidubicel and Orca-T Products If the product is Omidubicel, select Ex vivo expansion for the first product and Other manipulation for the second product – specify the manipulation as ‘Negative fraction.’ If the product is Orca-T, report the manipulation as CD34 enriched.
3/8/2024	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Add	Omidubicel and Orca-T Products blue box added above Q34: Omidubicel and Orca-T Products If the product is Omidubicel or Orca-T, select Yes the product was manipulated.
9/23/2022	2006: Hematopoietic Stem Cell Transplant (HCT) Infusion	Modify	Version 5 of the 2006: Hematopoietic Stem Cell Transplant (HCT) Infusion section of the Forms Instruction Manual released. Version 5 corresponds to revision 6 of the Form 2006.

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.