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

If any portion of the product was thawed prior to this infusion, select “yes” and continue with question 23.

If the product was never cryopreserved, select “no” and continue with question 32.

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” and continue with question 26.

If the entire product was not thawed, select “no” and continue with question 24.

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

Indicate the percent of the product that was thawed. If the exact percent is not listed, specify the percent of the product that was thawed in question 25.

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 in question 26. 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 thawing method used to thaw the product. If a method other than “water bath” or “electric warmer” was used, select “other method” and specify the method in question 30.

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.

Question 32: Was the product processed prior to infusion?

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.

If the product was not processed, select “no” and continue with question 34.

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

Diluted: Dilution is performed to reduce the cell concentration.1

Plasma reduced: Plasma reduction is performed to remove plasma via sedimentation or centrifugation.1

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

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

Question 34: Was the product manipulated prior to infusion?

If any part of the product was manipulated in any way prior to infusion at the transplant center, select “yes” and go to question 35.

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

If the product was not manipulated, select “no” and continue with question 41.

Questions 35: Specify manipulations performed: (check all that apply)

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

If the product manipulation is ex-vivo expansion, genetic manipulation or CD34 enriched, continue to question 41.

If the product is ex-vivo T-cell depleted, continue to question 36.

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” for question 35 and specify the method in question 40. Do not report cryopreservation (or processing used in the cryopreservation process) as manipulation.

1ISTB 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. If antibodies were used during product manipulation, but are not listed above, select “other antibody” for question 36 and specify in question 37.

Questions 38-39: Specify T-cell depletion method:

Indicate the T-cell depletion method used during product manipulation. If the method used during manipulation is not listed above, select “other method” for question 38 and specify in question 39.

Question 40: Specify other cell manipulation:

If a method of manipulation was performed on the product, but is not captured above, specify the method in question 40. Do not report cryopreservation (or processing used in the cryopreservation process) as manipulation.

Last modified: Jan 27, 2020

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