Q30 – 66: Donor Information

*Orca Bio Products and Donor Information
Refer to the Orca Bio Reporting Guide, located on CIBMTR Portal, to determine how to report donor information for Orca Bio products.

*Omidubicel Product
If the product is Omidubicel, select No for multiple donors.

Question 30: Multiple donors?

Indicate if cells from multiple different donors (multiple CBUs, combinations of other products from different donors) are to be used for this infusion.

For example, supplemental infusions should be included when determining if multiple donors were used for this infusion event. An infusion of supplemental cells is often given in conjunction with a preparative regimen for HCT. A supplemental infusion is defined as an infusion of cells given prior to clinical day 0 (of an HCT) for any reason other than to produce engraftment.

For more information on supplemental infusions, see Appendix D: How to Distinguish Infusion Types.

If multiple donors were not used, select No.

Question 31: Specify number of donors

Report the number of donors used for this infusion. This value should never be “1,” since it is reported Yes, there were multiple donors reported in the prior question.

*Reporting More Than One Donor
Complete the donor specific questions to report more than one donor by adding an additional instance in the FormsNet3^SM application.

Question 32: Specify donor

Indicate the donor type for this product.

• Autologous: Cells collected from the recipient for his / her own use.
• Allogeneic, related: A related donor who is a blood-related relative. This includes monozygotic (identical twins), non-monozygotic (dizygotic, fraternal, non-identical) twins, siblings, parents, aunts, uncles, children, cousins, half-siblings, etc.
• Allogeneic, unrelated: An unrelated donor who shares no known ancestry with the recipient. Include adoptive parents / children or stepparents / children.
  

*Omidubicel Product
If the product is Omidubicel, report the product type as CBU.

*Multiple Products for a Single Donor
Previous CIBMTR forms required two instances to be entered in the donor section when a single donor donated multiple products. This is no longer required. Report all products collected from a single donor in the same instance of the donor section.

Questions 33 – 34: Specify product type (check all that apply)

Select list of product type(s) for the donor being reported in this instance.

If Other product is indicated, specify the product type. If there is a protocol where using “other products” is common, consistently report the same text in the specify field so that the “like” products can be grouped together. Do not report the cell type (i.e., CD3+ cells), report the product type.

*Omidubicel Product
If the product is Omidubicel, report No, the product was not genetically modified.

Question 35: Is the product genetically modified?

The intent of this question is to capture genetically modified HCT products or gene therapy products. Genetically modified products include any product where the cells are manipulated via either:

• Gene transfer: a process by which copies of a gene are inserted into living cells in order to induce synthesis of the gene’s product; or
• Transduction: a process by which foreign DNA is introduced into a cell by a virus or viral vector
  

These techniques alter its gene expression through the insertion of different genes or editing of genes.

Specify if the product is genetically modified. If more than one product is being infused, indicate if any of the products are genetically modified.

Question 36: Specify the related donor type

Indicate the relationship and match between the recipient and the related donor being reported in this instance. When determining the donor’s match / mismatched relationship to the recipient, only consider HLA-A, B, C, and DRB1.

• Syngeneic (monozygotic twin): Monozygotic (identical) twins. Occurs when a single egg is fertilized to form one zygote, which then divides into two separate embryos.
  • Does not include other types of twins or HLA-identical siblings.
• HLA-identical sibling (may include non-monozygotic twin): Non-monozygotic (dizygotic, fraternal, non-identical) twins. Occurs when two eggs are fertilized by two different sperm cells at the same time. Also includes siblings who aren’t twins but have identical HLA types. The recipient and donor will be allele level matched at HLA-A, B, C, and DRB1.
  • Does not include half-siblings (report as H*LA-matched other relatives* if their HLA typing is a match, or HLA-mismatched relative if it does not match).
• HLA-matched other relative (does NOT include a haplo-identical donor): All blood-related relatives, other than siblings, who are HLA matched (i.e., parents, aunts, uncles, children, cousins, half-siblings). The recipient and donor will be allele level matched HLA-A, B, C, and DRB1.
  • Does not include adoptive parents / children or stepparents / children who are HLA matched.
• HLA-mismatched relative (includes haplo-identical donor): Siblings who are not HLA-identical and all other blood-related relatives who have at least one HLA mismatch (mismatch can be at the antigen or allele level) (i.e.., parents, aunts, uncles, children, cousins, half-siblings). The recipient and donor will be antigen or allele level mismatched at 1 or more loci (HLA-A, B, C, or DRB1). Select this option for haploidentical transplants.
  • Does not include adoptive parents / children or stepparents / children.

Questions 37 – 38: Specify the biological relationship of the donor to the recipient

Indicate the relationship between the recipient and the related donor being reported in this instance. If the donor is Other biological relative, specify the donor’s relationship to the recipient.

Question 39: Degree of mismatch (related donors only)

If the donor being reported in this instance is an HLA-mismatched relative, indicate the degree of mismatch as either HLA-mismatched 1 allele or HLA-mismatched ≥ 2 alleles (does include haploidentical donor).

Haploidentical means that one half of the HLA type matches the recipient. This type of HLA mismatch is common between blood-related parents and children. When determining the donor’s matched/mismatched relationship to the recipient, only consider HLA-A, B, C and DRB1

Question 40: Specify unrelated donor type

Indicate the unrelated donor type. When determining the donor’s matched / mismatched relationship to the recipient, only consider HLA-A, B, C, and DRB1.

Question 41: Did NMDP facilitate the procurement, collection, or transportation of the product?

Determine if NMDP facilitated the procurement, collection, and / or transportation of the product (i.e., the product from the donor being reported in this instance is an NMDP product or a non-NMDP product). Examples of non-NMDP donor registries include but are not limited to St. Louis Cord Blood Bank, Anthony Nolan, and StemCyte International Cord Blood Center. This information is included on the product label, the paperwork accompanying the product, and within NMDP search/product documentation.

If the documentation is unclear if NMDP facilitated the procurement, collection, and / or transportation of the product, seek clarification from the transplant coordinator.

If the recipient received a product facilitated by NMDP select Yes and report the NMDP cord blood unit ID or the GRID. Additionally, ensure the NMDP RID is reported on the CRID Assignment (2804) Form. For products facilitated by NMDP, the Registry or UCB Bank ID question will be disabled, and the Infectious Disease Markers (2004) and HLA Typing (2005) forms will not come due.

Below is a list of donor registries who were once “non-NMDP” registries but may now be an “NMDP-facilitated” registry:

• Matchis Foundation 71 (Netherlands)
• Hadassah Medical Organization 72 (Israel)
• Knochenmarkspenderzentrale – Dusseldorf 114 (Germany)
• The Tobias Registry of Swedish Bone Marrow Donors 119 (Sweden)
• The Norwegian Bone Marrow Donor Registry 120 (Norway)
• Welsh Bone Marrow Donor Registry 131 (Wales)
• British Bone Marrow Registry 134 (United Kingdom)
• Anthony Nolan 135 (United Kingdom)
• ZKRD 136 (Germany)
  

Question 42: Was this donor used for any prior HCTs? (for this recipient)

Indicate if the current donor for this infusion was used for any prior HCTs for this recipient. If this is the recipient’s first HCT or is an autologous infusion, select No.

*GRID
The GRID has its own section on the Pre-TED (2400) form. Therefore, only the 19-character donor identifier needs to be reported. This is essential for proper donor linking and, if done incorrectly, will result in queries being placed on the form.

*GRIDs from DKMS
If receiving a GRID from the DKMS registry, the eighth character is being reported as the letter “O” however, this character should be the number “0”. When entering a GRID from the DKMS ensure that the eighth character reported is the number “0”.

Question 43: Global Registration Identifier for Donors (GRID)

The Global Registration Identifier for Donors (GRID) was developed by the World Marrow Donor Association (WMDA) to ensure secure, reliable and unambiguous assignment of donors. The GRID standard is a 19-character donor identifier composed of three elements: Issuing Organization Number (ION), Registration Donor Identifier, and Checksum (shown below). This standard will ensure each donor ID is globally unique and will reduce the risk of misidentification of donors or their donations.

https://www.wmda.info/professionals/optimising-search-match-connect/why-global-identifier/

Question 44: NMDP cord blood unit ID

Report the NMDP Donor ID (i.e., 0000-0000-0). This ID is unique for each donor and is assigned by NMDP. This information is included on the product label, the paperwork accompanying the product, and within the NMDP search / product documentation.

Question 45: Registry donor ID (not applicable for related donors)

Report the non-NMDP unrelated donor ID. Examples of non-NMDP donor registries include Australia Bone Marrow Donor Registry and REDOME. This ID may be located on the product label, the paperwork accompanying the product, and registry-specific search / product documentation.

Question 46: Non-NMDP cord blood unit ID (include related and autologous CBUs)

Report the non-NMDP cord blood unit ID. Examples of non-NMDP donor registries include St. Louis Cord Blood Bank and StemCyte International Cord Blood Center. This ID is often located on the product label, the paperwork accompanying the product, and registry-specific search / product documentation.

Some cord blood banks may ship their units either through NMDP or directly to the transplant center. Carefully review the accompanying documentation to determine which is appropriate for your unit. Consult with the center’s transplant coordinator if it is unclear how the product was acquired.

*ION and Affiliated to ION Available
If a registry or UCB bank has both an ION and an affiliated to ION, report the registry’s or UCB bank’s ION (not the affiliated to ION).

*Determining ION or Affiliated ION
To find an ION or affiliated ION visit WMDA.

Questions 47 – 48: Registry or UCB Bank ID

Specify the registry or umbilical cord blood (UCB) bank used to obtain the adult donor or umbilical cord blood unit. If Other Registry is selected, specify the four-digit ION or affiliated ION. If the registry or UCB bank does not have ION or affiliated ION, report the organization’s official name.

The World Marrow Donor Association (WMDA) ions have been adopted to avoid submitting the entire name and address when reporting the registry or UCB bank.

• ION: Issuing organization number allocated by International Council for Commonality in Blood Banking Automation (ICCBBA) in collaboration with the World Marrow Donor Association (WMDA)
• Affiliated ION: A registry or UCB bank may not have its own ION but is “affiliated to” a registry or UCB bank.
  • To find an affiliated ION
    • Navigate to the WMDA website
    • Use the ‘Filter’ to find the organization that provided the unit
    • The ‘affiliated to’ column will contain the affiliated ION (if one exists)

Review the diagram below when reporting the registry or UCB bank ID:

Questions 49 – 50: Donor date of birth

Report if the donor’s / infant’s date of birth is Known. If Known, report the date of birth (YYYY-MM-DD).

Questions 51 – 52: Donor age

Report if the donor’s / infant’s age is Known. If Known, report the donor’s / infant’s age at the time of product collection. Report the age in months if the donor is less than one year old, otherwise report the age in years.

Question 53: Donor sex

Indicate the donor’s sex. Sex shall refer to an individual’s immutable biological classification as either male or female. Sex is not a synonym for and does not include the concept of gender identity. For cord blood units, report the infant’s sex.

Question 54: Specify blood type (donor) (non-NMDP allogeneic donors only)

Indicate the donors’ blood type as A, B, AB, or O. Blood type is an important characteristic in allogeneic transplant because products may require manipulation to minimize the risk of immune reaction due to incompatibility.

Question 55: Specify Rh factor (donor) (non-NMDP allogeneic donors only)

The Rh factor is an important characteristic in allogeneic transplant because products may require manipulation to minimize the risk of immune reaction due to incompatibility.

Report the donor’s Rh (rhesus) factor.

Question 56: Donor CMV-antibodies (IgG or Total) (Allogeneic HCTs only)

CMV is a common virus that infects 50-80% of adults worldwide and is transmitted from person to person through bodily fluids. The virus that causes CMV is part of the herpes virus family and, like other herpes viruses, CMV may be dormant for a period of time before the virus is activated in the host. CMV infections are usually harmless in a healthy immune system and typically cause only mild symptoms, if any. However, if a person’s immune system is seriously weakened (as in an immunosuppressed stem cell recipient) the virus can have serious consequences such as pneumonia, liver failure, and even death.

Most laboratory reports indicate a positive result as reactive, and a negative result as non-reactive. Occasionally, laboratory reports show a specific antibody titer. In this case, compare the laboratory result to the reported standards to determine if the result was reactive or non-reactive.

Report the test result as documented on the laboratory report.

If the laboratory reports the results as “inconclusive” or “equivocal,” select Indeterminant.

If the laboratory reports a CMV IgM antibody only, not total IgG/IgM or CMV IgG antibody; report the result as Not done.

If the laboratory reports CMV testing by PCR (DNA detection), report the result as Not done. CMV testing by PCR is used to detect the presence of the CMV virus and does not test for prior exposure.

Question 57: Has the donor signed an IRB / ethics committee (or similar body) approved consent form to donate research blood samples to NMDP / CIBMTR? (Related donors only)

Indicate if the related donor signed an IRB-approved consent form to donate research blood samples to NMDP / CIBMTR. This question should only be answered if this is the recipient’s first allogeneic transplant.

Question 58: Date form signed

Report the date (YYYY-MM-DD) the research sample consent form was signed by the related donor. Do not report the date that the witness or healthcare professional signed the consent form.

Questions 59 – 60: Did the donor submit a research sample to the NMDP / CIBMTR repository? (Related donors only)

There are a select number of transplant centers participating in the Related Sample Repository. If the center is one of the participating centers, and the donor provided a research sample, select Yes and provide the donor’s sample ID for the current infusion. The ID number is located on the bar code that is attached to the sample tube.

*Omidubicel Product
If the product is Omidubicel, report the number of products from the donor as two.

Question 61: Specify number of products infused from this donor

Report the number of products infused from the donor being reported for this HCT. See below for examples of HCT and gene therapy products.

HCT

• Single Product: CIBMTR defines a single product (i.e., cellular product) as cells collected from a single donor using the same mobilization cycle and collection method regardless of the number of collection days.
  • Example 1 (multiple bags): A G-CSF stimulated donor had two PBSC collections on subsequent days. The products collected over the two days were divided into four bags. Although the product is contained in multiple bags, this collection is considered a single product, as there was no change in mobilization technique or collection method.
  • Example 2 (change in mobilization): A G-CSF stimulated donor had a PBSC collection, but the cell count was poor. Plerixafor (Mozobil) was added as part of the mobilization and the donor was re-collected the following day. As the change in mobilization occurred during the same mobilization cycle, these collections are considered a single product.
• Multiple Products: For the purposes of this manual, CIBMTR defines multiple products as cells collected using more than one mobilization technique and / or collection method.
  • Example 3 (multiple collection methods): A G-CSF-stimulated donor had a PBSC collection, and the product was cryopreserved. One month later the donor had a marrow collection; both products were infused at the time of transplant. Each collection is considered a separate product because different collection methods were used. The number of products infused from this donor is two.
  • Example 4 (re-mobilization): A G-CSF-stimulated donor had a PBSC collection, but the cell count was poor. No further collections were attempted and a week later the donor was re-mobilized with G-CSF and a second PBSC collection was performed. Each collection is considered a separate product due to the re-mobilization of the donor.
  • Example 5 (two different product types): A cord blood unit is infused at the same time as marrow. Each product type is considered a separate product. The number of products infused is two.

Gene Therapy

• Single Product
  • Example 6 (multiple days of collection): A single mobilization event, even when cells were collected over several days.
  • Example 7 (multiple mobilizations and / or manufacturing steps): A recipient may require multiple mobilizations, and possibly multiple manufacturing steps, for the final product intended for infusion. This should be considered as a single gene therapy product, regardless of how many mobilizations or steps are required for manufacturing.

*Omidubicel Product
If the product is Omidubicel, report the number of products intended to achieve hematopoietic engraftment as two and complete two HCT Product and Infusion (2006) forms.

Question 62: Specify the number of these products intended to achieve hematopoietic engraftment

If infusions of additional cells (not intended to product engraftment) were given as a supplemental infusion either prior to the HCT being reported (i.e., prior to clinical Day 0) or shortly after the HCT being reported, the cells must be reported as a product on the Pre-TED Form (2400) form and on a separate Cellular Therapy Product (4003) form.

If additional cells were infused post-HCT, for any reason other than a subsequent HCT or a supplemental infusion as part of the HCT, they should be reported as cellular therapy on the appropriate follow-up form. Reporting the additional cells (given pre-HCT and not intended to produce engraftment) on the Cellular Therapy Product (4003) form is the only mechanism CIBMTR has in place to collect this data and ensure that the quality assurance data is reported to the cord blood banks, if applicable.

Report the number of products administered to achieve hematopoietic engraftment.

Questions 63 – 64: What agents were used to mobilize the autologous recipient for this HCT? (check all that apply)

Report the agents used in the mobilization event(s). If completing this form for a subsequent infusion and the same mobilizing agents used for the previous were used for the current infusion, re-report the mobilizing agents used for the current infusion.

• G-CSF: TBO-filgrastim, filgrastim, Granix, Neupogen® and biosimilars
• GM-CSF: sargramostim, Leukine
• Pegylated G-CSF: pegfilgrastim, Neulasta®
• Motixafortide: Aphexda
• Perlixafor: Mozobil® and biosimilars
• Combined with chemotherapy: Systemic therapies used to enhance the stem cell product may include cyclophosphamide or ICE chemotherapy (Ifosfamide, carboplatin, and etoposide) with or without rituximab.
• Anti-CD20: rituximab, Rituxan®
• Other agent: If an agent was used but not listed above, select Other agent and specify.
  

Questions 65 – 66: Name of product (gene therapy recipients)

Report the name of the product. If the name is not listed, select Other name and specify the gene therapy product name.

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.