Policies & Protocols

Cord Blood Bank Qualification and Membership

The National Marrow Donor Program (NMDP)/Be The Match sponsors an FDA-approved Investigational New Drug (IND) application (BB-IND 7555). This IND allows us to facilitate access to unlicensed cryopreserved allogeneic umbilical cord blood units (HPC(CB)) for unrelated recipients in the United States. The IND supports HPC(CB) from both U.S. and non-U.S. cord blood banks (CBBs) that are not licensed in accordance with 21 CFR 601.

Any HPC(CB) shipment facilitated by NMDP/Be The Match and distributed in the United States, must use an FDA-accepted IND application or Biologics License Application (BLA). If a CBB (U.S. or non-U.S.) wishes to provide unlicensed HPC(CB) to U.S. patients through NMDP/Be The Match, it must qualify under the NMDP’s IND, or another FDA-approved IND. If a CBB’s entire inventory is FDA-licensed, the requirement to qualify under an IND may be waived.

CBBs that wish to provide unlicensed HPC(CB) to U.S. recipients under the NMDP/Be The Match IND must meet IND qualification requirements as defined by NMDP/Be The Match and approved by the FDA, in addition to meeting applicable regulations within their own country. Specific requirements for qualification are listed within the IND. Published separately and available publicly are the:

All CBBs must submit documentation initially and complete an annual survey to demonstrate compliance with applicable NMDP requirements.

Affiliated Cord Blood Banks

CBBs that meet NMDP/Be The Match Investigational New Drug (IND) Supplier Requirements for Cord Blood Banks and have received notification of an approved NMDP/Be The Match Investigational New Drug (IND) Qualification Form for Cord Blood Banks are referred to as affiliated cord blood banks.

The initial submitted NMDP/Be The Match Investigational New Drug (IND) Qualification Form for Cord Blood Banks is reviewed by the NMDP/Be The Match Qualification Review Team (QRT). The QRT will meet on an as-needed basis, as new requests for qualification are received. Final approvals are provided by the Principal Investigator of BB-IND 7555.

Affiliated CBBs must participate in this category for at least six months before requesting to become an NMDP/Be The Match member cord blood bank.

Benefits for affiliated CBBs:

  • Facilitation of testing and importation of unlicensed HPC(CB) for U.S. patients by NMDP/Be The Match via an FDA-approved IND.
  • Inclusion of HPC(CB) in specialized NMDP/Be The Match search results generated for NMDP/Be The Match network transplant centers and cooperative registries if CBB submits data to BMDW or uses EMDIS. HPC(CB) appear on these specialized lists with a bank/registry-provided local ID number.


Becoming an NMDP/Be The Match Member Cord Blood Bank

An affiliated CBB interested in membership must submit the NMDP/Be The Match Application to Participate as a Member Cord Blood Bank. Applicant CBBs must also successfully pass an on-site audit conducted by NMDP staff.

Initial applications to participate as a member CBB are reviewed by NMDP/Be The Match staff representing Regulatory Compliance and Cord Blood Operations. Recommendations for approval are provided by the NMDP/Be The Match Membership Review Committee (MRC), followed by either the NMDP/Be The Match executive committee or board of directors.

Audits performed at applicant member CBBs will be performed by representatives of Regulatory Compliance and Cord Blood Operations.


Member Cord Blood Banks

In addition to the requirements of affiliated CBBs, NMDP/Be The Match member cord blood banks must be accredited by AABB or NetCord-FACT, adhere to and have at least 500 HPC(CB) units that meet NMDP/Be The Match Current Inventory Requirements for New Cord Blood Units, be actively collecting HPC(CB), meet NMDP/Be The Match Member Cord Blood Bank Participation Criteria, and abide by NMDP/Be The Match Standards.

Member CBBs provide HLA and other relevant information about their HPC(CB) to the NMDP for listing in the Be The Match Registry® using NMDP/Be The Match provided software. These HPC(CB) are assigned an NMDP ID number and are on the up-front search result listings to transplant centers and registries.

Benefits for member CBBs:

  • Facilitation of testing and importation of unlicensed HPC(CB) for U.S. patients by NMDP/Be The Match via an FDA-approved IND.
  • Inclusion of HPC(CB) in the up-front search results generated for NMDP/Be The Match network transplant centers and cooperative registries.
  • Eligibility for invitation of one representative to participate as a voting member of the NMDP/Be The Match Cord Blood Advisory Group.
  • Eligibility to attend the NMDP/Be The Match Council Meeting under the terms of the NMDP/Be The Match Council Meeting Grant Program.
  • Eligibility to participate in NMDP special programs, initiatives and pilot programs.
  • No-cost access to educational materials and documents produced by the NMDP/Be The Match, the NMDP/Be The Match Network website, and NMDP/Be The Match software applications used to list HPC(CB) in the Be The Match Registry.

Annual Renewal

Ongoing compliance of NMDP/Be The Match Investigational New Drug (IND) Supplier Requirements for Cord Blood Banks, NMDP/Be The Match Member Cord Blood Bank Participation Criteria, and NMDP/Be The Match Current Inventory Requirements for New Cord Blood Units will be performed by NMDP/Be The Match staff on an annual basis for both affiliated and member CBBs.

The vice president and senior medical director of the NMDP/Be The Match, as principal investigator of BB-IND 7555, is responsible for oversight of policies and procedures that affect the qualification and continued compliance of CBBs.

The chief operations officer is responsible for the oversight of staff in cord blood operations for tasks relevant to qualification and renewal.

Non-compliant banks will be brought to the attention of the principal investigator of BB-IND 7555 and the NMDP/Be The Match Membership Review Committee.

Questions?

Contact the Cord Blood Bank Liaison team at cordliaisons@nmdp.org.