Q22 – 41: Product Processing / Manipulation

Question 22: Was the product thawed from a cryopreserved state prior to infusion?

Indicate if any portion of the product was thawed prior to this infusion. If the product was never cryopreserved, select No.

Question 23: Was the entire product received by the center thawed?

The intent of this question is to determine whether the entire product collected was thawed for infusion. A product may have been collected as a single product bag and then cryopreserved and stored in compartments. For example, the product could be stored in a 500 mL bag with five 100 mL cryopreserved compartments, or it could be stored in multiple separate product bags that have been cryopreserved.

Indicate if the entire product (all compartments or all product bags collected) received by the center was thawed.

If this infusion is using “leftover” cells from a previous infusion, the “leftover” portion is now considered the entire product. Therefore, if all the “leftover” cells were thawed, select Yes. If a portion of the “leftover” cells were not used and remain frozen, select No.

• Example 1: A cryopreserved product was collected and arrived at the center in two bags. The intent was to thaw and infuse one bag and save the remaining cryopreserved bag for future use, such as for a DLI. Report No, the entire product was not thawed as only one bag of the collected product was thawed.

Question 24: Date thawing process initiated

Report the date the thawing process began.

Question 25: Time at initiation of thaw (24-hour clock)

Report the time the product thaw began, using a 24-hour clock.

If multiple bags of the same product are thawed, report the time the first bag begins thawing. The exact time should be documented within the recipient’s record or the stem cell laboratory processing record. If the start time is not documented, leave the data field blank and override the FormsNet3^SM error as ‘not documented.’

Question 26: Time of thaw completion (24-hour clock)

Report the time the product thaw completed, using a 24-hour clock.

If multiple bags of the same product are thawed, report the time the last bag finished thawing, even if the date is not the same as the reported thaw start date above. The exact time should be documented within the recipient’s record or the stem cell laboratory processing record. If the stop time is not documented, leave the data field blank and override the FormsNet3^SM error as ‘not documented.’

Questions 27 – 28: What method was used to thaw the product?

Report the method used to thaw the product. Only report the method of thawing the product. If a method other than Water bath or Electric warmer was used, select Other method and specify the method.

Question 29: Did any incidents or product complaints occur while preparing or thawing the product?

Indicate if any incidents occurred regarding the product during the thawing process.
If any product complaints were found while preparing or thawing the product, a product complaint form (Form 3010) must be completed. Possible complaints include, but are not limited to, broken bags, a clot in the product, or missing documentation used to identify the product.

*Product Processing
Wash and dilution, both which generally apply to cord blood units, are now included as processing options, though they may not be classified as such by laboratories. If dilution is performed as part of washing, dilution should not be reported as a product processing. Only report the primary procedure. See the Steps in Manipulation note box below.

!Product Processing as Part of Cryopreservation
Product processing performed as part of the cryopreservation process should not be reported as a separate process. For example, plasma reduction / removal or buffy coat enrichment performed as part of the cryopreservation process should not be reported as product processing.

Question 30: Was the product processed prior to infusion?

Product processing includes changes made to the original product that do not affect the physical properties of the product (i.e., plasma reduction, RBC reduction, was).

Indicate if the product was processed prior to infusion at the center. If any part of the product was processed in any way prior to infusion at the center, select Yes.

If the product was shipped to your facility, do not report processing of the product performed at the collection center.

Question 31: Specify processing (check all that apply)

Indicate the method(s) of stem cell processing. Select all that apply.

• Buffy coat enriched: Buffy coat enrichment is performed to reduce/remove mature erythrocytes and plasma.¹ Buffy coat enrichment performed as part of the cryopreservation process should not be reported as product processing.
• Diluted: Dilution is performed to reduce the cell concentration.¹
• Plasma reduced: Plasma reduction is performed to remove plasma via sedimentation or centrifugation.¹ Plasma reduction / removal performed as part of the cryopreservation process should not be reported as product processing.
• RBC reduced: RBC reduction is performed to reduce/remove mature erythrocytes from the product.¹
• Washed: Washing is performed to remove cryoprotectant (such as DMSO) from the product.¹

¹ ISTB 128. Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. ICCBBA ST-002. Version. 4.9. March 2012.

*Orca Bio Products and Processing / Manipulation
Refer to the Orca Bio Reporting Guide, located on the CIBMTR Portal, to determine how to report processing and manipulation for Orca Bio products.

*Omidubicel Products
If the product is Omidubicel, select Yes the product was manipulated.

Question 32: Was the product manipulated prior to infusion?

Product manipulation includes changes made to the original product affecting the physical properties of the product (i.e., ex-vivo T-cell depletion or CD34 selection).

Indicate if the product was manipulated prior to infusion at the center. If any part of the product was manipulated in any way prior to infusion at the center, select Yes.

If the product was shipped to your facility, do not report manipulation of the product performed at the collection center.

*Omidubicel Products
If the product is Omidubicel, select Ex vivo expansion for the first product and Negative fraction for the second product.

*Steps in Manipulation
If the manipulation consists of several steps, individual steps do not need to be reported as separate manipulations. For example, T-cell depletion that is part of expansion does not need to be reported. In the case above, if T-cell depletion is done as a stand-alone manipulation, this should then be reported.

Questions 33 – 36: Specify manipulations performed (check all that apply)

Indicate the method(s) of stem cell manipulation. It is not necessary to report antibodies used as part of CD34+ enrichment using CliniMACS®, Isolex, or Miltenyi devices.

• Ex-vivo expansion: Ex-vivo expansion is a method of culturing cells to “activate, expand, or promote development of a specified cell population in the presence of specific additive(s).” (ISBT, 2012)¹ . If Ex-vivo expansion is selected, specify the type.
• Genetic manipulation (gene transfer / transduction): Gene manipulation refers to any method used to modify the genes in the product cells. Gene transduction refers to the transfer of genes from one cell to another. Using genetic manipulation is still in the “research” stage. If Genetic manipulation (gene transfer / transduction) is selected, specify the manipulation.
• CD34 enriched (CD34+ selection): CD34+ selection is a manipulation method also known as “positive selection.” This method identifies and selects stem cells that have a CD34+ marker on the cell surface.
• Ex-vivo T-cell depletion: T-cell depletion removes some or all the T cells to minimize GVHD. Methods of T-cell depletion include antibody affinity column, antibody-coated plates, antibody-coated plates and soybean lectin, antibody + toxin, immunomagnetic beads, CD34 affinity column plus sheep red blood cell resetting, and T-cell receptor alpha / beta depletion.
• Negative fraction: Negative fraction refers to the portion of the collected blood or stem cell product that does not contain the desired cells and removed or discarded during processes like plasma reduction or cell separation.

If a method of manipulation was performed on the product, but is not listed above, select Other manipulation and specify the method. Do not report cryopreservation (or processing used in the cryopreservation process) as manipulation.

¹ ISTB 128. Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. ICCBBA ST-002. Version. 4.9. March 2012.

Questions 37 – 38: Specify antibodies used (check all that apply)

Specify the antibodies used for ex-vivo T-cell depletion.

• Anti-CD3: Agent / antibody that binds to CD3 surface proteins on T-cells.
• Anti-CD4: Agent / antibody that binds to CD4 surface proteins on T-cells.
• Anti-CD8: Agent / antibody that binds to CD8 surface proteins on T-cells.
• Anti-CD19: Agent / antibody that binds to CD19 surface proteins on T-cells.
• Anti-CD45RA: Agent / antibody that binds to CD45 surface proteins on T-cells. Examples of monoclonal antibodies used in T-cell depletion include OX33.
• α/β Antibody: Agent / antibody that binds to TCRs on peripheral blood CD3+ T cells. Examples of monoclonal antibodies used in T-cell depletion include IP26 and T10B9
• Anti-CD52: Agent / antibody that binds to CD52 surface proteins on T-cells.

If antibodies were used during ex-vivo T-cell depletion but not listed above, select Other antibody and specify the antibody.

Questions 39 – 40: Specify T-cell depletion method

Indicate the T-cell depletion method used during product manipulation.

• Antibody affinity column: A separation process used to purify a solution or mixture into distinct components.
• Immunomagnetic beads: Uniform polymer particles coated in a polystyrene casing that provides a hydrophobic surface to facilitate physical absorption of molecules, such as antibodies (e.g., CliniMACS®)
  

If the method used during t-cell depletion is not listed above, select Other method and specify the method.

Question 41: Specify other cell manipulation:

If a method of manipulation was performed on the product, but is not captured above, specify the method. Do not report cryopreservation (or processing used in the cryopreservation process) as manipulation.

Section Updates:

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