Question 1: Name of product:
The name of the product reported will be auto-populated from what was reported on Form 4000. This question is limited to commercialized products and is used to disable questions related to manufacturing.
If a commercially available product is selected, several questions on this form will be disabled and cannot be answered.
Question 2-3: Cell product ID :
Report if the product has a cell product ID in question 2 and specify the ID in question 3. Product IDs can be numeric or alphanumeric.
Question 4-5: Batch number:
Report if the product has a batch number in question 4 and specify the batch number in question 5. Batch numbers can be numeric or alphanumeric
Question 6-7: Lot number:
Report if the product has a lot number in question 6 and specify the Lot number in question 7. Lot numbers can be numeric or alphanumeric
Question 8: Date of this product infusion:
Report the date (YYYY-MM-DD) this product was infused. If the product was infused over multiple days, report the first date of infusion.
If the exact date is unknown, please view General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.
Question 9-11: Was the entire volume of product infused?
If the product being infused as a cellular therapy is a portion from a prior HCT (e.g. DLI/DCI), the portion becomes the “entire” product for the purposes of this form. The intent is to capture if the product being infused was given in its entirety or not.
If the entire volume of the product was not infused, specify what happened to the reserved portion in question 10 and 11.
Question 12-13: Specify the route of product infusion:
refers to an infusion into the veins – examples include infusion via central line or via catheter.
refers to an infusion into the marrow cavity within a bone, such as directly into the proximal tibia or anterior aspect of the femur.
refers to an infusion within the peritoneal cavity.
refers to an infusion within an artery or arteries.
refers to an infusion within a muscle.
refers to an infusion within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
refers to an infusion within an organ such as the heart, liver, lungs, etc. Specify the site in question 14.
refers to an infusion in a restricted area of the body or in a tumor that cannot be classified as intraorgan.
If the route of infusion is not one of the above options, select “other route of infusion” and specify the infusion route in question 13.
Question 14-15: Specify the site of intraorgan administration of cells:
If the route of product infusion was intraorgan, specify the site of intraorgan administration. If the site of infusion is not in the option list, select “other site” and specify the site in question 15.
Question 16: Recipient weight used for this infusion:
Report the recipient’s body weight used to calculate the cell dose for this infusion. This weight is usually documented on infusion orders or admitting orders. Report weight to the nearest whole kilogram or pound (round up if 0.5 or greater). It could be the recipient’s actual weight or adjusted body weight. Do not report lean body weight or ideal body weight.
Question 17: Recipient height used for this infusion:
Report the recipient’s height at infusion. Report the recipient’s height to the nearest whole centimeter or inch (round up if 0.5 or greater).
This section collects the total number of cells that were infused in a specific product. All of the cells that were listed on the F4003 Cellular Therapy Product in question 6 are included here. Only respond to the cells that are applicable to this infusion. Note, CD3 is present on all T-cells whether they are CD4+ or CD8+ T-cells.
Question 18-19: Total number of cells administered:
Report the total cell count contained in the product administered. If the type of cells are not specified, report the total number of cells present at time of the infusion. If multiple bags were infused together, report the sum of each bag.
Question 20-21: Lymphocytes (unselected) administered:
Unselected means a specific lymphocyte sub-population (e.g. CD4+) was not targeted. This includes all types of lymphocytes, those that have not been selected via flow cytometry or other method. If yes, report the total number of unselected lymphocytes (e.g., CD3+ cells) administered in the product in question 21.
Question 22-23: CD4+ lymphocytes administered:
The lab report may display this value as CD3+CD4+. These cells are also known as T-helper cells. If yes, report the total number of CD4+ cells administered in the product in question 23.
Question 24-25: CD8+ lymphocytes administered:
The lab report may display this value as CD3+CD8+. These cells are also known as T-helper cells. If yes, report the total number of CD8+ cells administered in the product in question 25.
Question 26-27: Natural killer cells (NK cells) administered:
NK cells are a type of cytotoxic lymphocyte critical to the innate immune system. They usually express CD56 / CD16 on their cell surface. If yes, report the total number of natural killer cells (NK cells) administered in the product in question 27.
Question 28-29: Dendritic cells / tumor cell hybridomas administered:
Dendritic cells are antigen-presenting cells (also known as accessory cells) of the immune system. Their main function is to process antigen material and present it on the cell surface to the T-cells of the immune system. If yes, report the total number of dendritic cells or tumor cell hybridomas administered in the product in question 29.
Question 30-31: Mesenchymal stromal stem cells (MSCs) administered:
MSCs are multipotent stromal cells that can differentiate into a variety of cell types, including: osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells). If yes, report the total number of MSCs administered in the product in question 31.
Question 32-33: Unspecified mononuclear cells administered:
A mononuclear cell is defined as any blood cell with a round nucleus (i.e., a lymphocyte, a monocyte, or a macrophage). These blood cells are a critical component of the immune system’s ability to fight infection and adapt to intruders. If yes, report the total number of unspecified mononuclear cells administered in the product in question 33.
Question 33-34: Endothelial progenitor cells (EPC) administered:
EPC is a term that is applied to multiple different cell types that play roles in the regeneration of the endothelial lining of blood vessels. If yes, report the total number of endothelial progenitor cells (EPCs) in the product in question 35.
Question 36-37 Human umbilical cord perivascular (HUCPV) cells administered:
HUCPV cell is a term that is applied to mesenchymal, non-hematopoietic, non-endothelial cells that are isolated from the umbilical cord. If yes, report the total number of human umbilical cord perivascular (HUCPV) cells in the product in question 37.
Question 38-39: Cardiac progenitor cells administered:
Cardiac progenitor cells are tissue-specific stem progenitor cells within the heart. If yes, report the total number of cardiac progenitor cells administered in the product in question 39.
Question 40-41: Islet cells administered:
Islet cells are found in the pancreas. The pancreas contains clusters of cells that produce hormones and these clusters are known as islets. If yes, report the total number of islet cells administered in the product in question 41.
Question 42-43: Oligodendrocytes administered:
Oligodendrocytes are glial cells similar to an astrocyte but with fewer protuberances. These cells produce myelin in the central nervous system. If yes, report the total number of oligodendrocytes administered in the product in question 43.
Question 44-46: Other cell type administered:
If a different cell type not previously mentioned was infused, specify the other cell type in question 45 and report the total number administered in the infusion in question 46.
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