Q36-42: Cell Product Analysis

!Product Analysis for Commercially Available Products
Cell product analysis questions will be disabled for commercially available and pre-commercial products. The questions will only enable if the product name was reported as Other product or No product name on the Pre-CTED (4000) form.

Question 36: Is the percentage of genetically modified cells known?

This question is only answered for genetically engineered/manipulated cells. The percentage of genetically modified cells, or transfection efficiency, is calculated as a percentage of transfected cells from all cells in the sample. There are several methods used to determine transfection efficiency including flow cytometry, fluorometry, microscopy, real-time quantitative PCR, etc.

This information will be available from the cell processing lab that is manufacturing the cellular product and may not be available in the medical record. Indicate Yes if transfection efficiency was done.

Question 37: Date percentage genetically modified cells sample collected

Specify the date when the sample was taken for the transfection efficiency testing.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 38: Percent of genetically modified cells

Report the percent of genetically modified cells in the product. Round to the nearest whole number.

Question 39: Was the target percent of genetically modified cells achieved?

The target percent if genetically modified cells, or transfection efficiency target, will be defined by the protocol. Indicate Yes or No if the target defined by the protocol was met.

Question 40: Was viability of cells done?

Indicate if the viability of cells was done prior to infusion. If the product was cryopreserved, viability post-thaw should be reported.

Question 41: Date viability of cells done

Specify the date when the sample was analyzed to determine viability, not the date the results are available.

For more information regarding reporting partial or unknown dates, see General Instructions, General Guidelines for Completing Forms.

Question 42: Viability of cells

Report the percent viability. Round to the nearest whole number.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
.	.	.	.	.

Copyright © 2004-2025 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.