Q22-40: 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 thawed?

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 500mL bag with five 100mL cryopreserved compartments, or it could be stored in multiple separate product bags that have been cryopreserved.

If the entire product (all compartments or all product bags) was thawed, select Yes.

If the entire product was not thawed, select No.

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.

Question 24 – 25: Specify the percent of the product that was thawed? (Cord blood units only)

Indicate the percentage of the product that was thawed. If the exact percentage is not listed, select Other percent and specify the percentage of the product that was thawed.

Question 26: Date thawing process initiated:

Report the date the thawing process began.

Question 27: Time at initiation of thaw (24-hour clock):

Report the time the product thaw began. Report the time using a 24-hour clock and indicate if daylight savings time or standard time was in effect. If the location of your institution or off-site laboratory does not observe daylight savings time, report the time as standard time. For more information about daylight savings time schedules, go to http://www.timeanddate.com/time/dst/.

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 patient record or the stem cell laboratory processing record.

Question 28: Time of thaw completion (24-hour clock):

Report the time the product thaw is completed. Show the time using a 24-hour clock and indicate if daylight savings time or standard time was in effect. If the location of your institution or off-site laboratory does not observe daylight savings time, report the time as standard time. For more information about daylight savings time schedules, go to http://www.timeanddate.com/time/dst/.

If multiple bags of the same product are thawed, report the time the last bag was finished thawing, even if the date is not the same as the date reported thaw start date above. The exact time should be documented within the patient record or the stem cell laboratory processing record.

Question 29: 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 to thaw the product, select Other method and specify the method

Question 31: 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 32: Was the product processed prior to infusion?

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

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

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

Question 33: Specify processing: (check all that apply)

Indicate the method(s) of stem cell processing.

• 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.

*Omidubicel and Orca-T Products
If the product is Omidubicel or Orca-T, select Yes the product was manipulated.

Question 34: 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).

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

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

*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.

Questions 35: 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 the CliniMacs, Isolex, or Miltenyi devices.

If the product is Ex-vivo T-cell depleted, specify the antibodies used.

*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.

• 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
• 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.
• 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 of the T cells in an effort 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.

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 36-37: 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 other antibody.

Questions 38-39: 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 40: 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:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
Q34	3/8/2024	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.	Added for product specific information
Q35	3/8/2024	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.	Added for product specific information

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