Cord blood bank qualification and membership

NMDP^SM 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 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, it must qualify under 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 IND must meet IND qualification requirements as defined by NMDP 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:

• AID-00096 NMDP Investigational New Drug (IND) Supplier Requirements for Cord Blood Banks (Legacy A00498)
• FRM-00203 NMDP Investigational New Drug (IND) Qualification Form for Cord Blood Banks (Legacy F00767)

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 IND Supplier Requirements for Cord Blood Banks and have received notification of an approved NMDP IND Qualification Form for Cord Blood Banks are referred to as affiliated cord blood banks.

The initial submitted NMDP IND Qualification Form for Cord Blood Banks is reviewed by the NMDP Qualification Review Team (QRT). The QRT meets 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 member cord blood bank.

Benefits for affiliated CBBs:

• Facilitation of testing and importation of unlicensed HPC(CB) for U.S. patients by NMDP via an FDA-approved IND.
• Inclusion of HPC(CB) in specialized NMDP search results generated for NMDP 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 member cord blood bank

An affiliated CBB interested in membership must submit the NMDP 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 staff representing Regulatory Compliance and Cord Blood Operations. Recommendations for approval are provided by the NMDP Membership Review Committee (MRC), followed by either the NMDP 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 member cord blood banks must be accredited by AABB or NetCord-FACT, adhere to and have at least 500 HPC(CB) units that meet AID-00131 NMDP Current Inventory Requirements for New Cord Blood Units (Legacy A00597), be actively collecting HPC (CB) at the time of application and membership, meet AID-00001 NMDP Member Cord Blood Bank Participation Criteria (Legacy A00092), and abide by NMDP.

Member CBBs provide HLA and other relevant information about their HPC(CB) to the NMDP for listing in the NMDP Registry^SM using NMDP 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 via an FDA-approved IND.
• Inclusion of HPC(CB) in the up-front search results generated for NMDP network transplant centers and cooperative registries.
• Eligibility for invitation of one representative to participate as a voting member of the NMDP Cord Blood Advisory Group.
• Eligibility to attend the NMDP Council Meeting under the terms of the NMDP 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, the NMDP Network website, and NMDP software applications used to list HPC(CB) in the NMDP Registry.

Annual renewal

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

The vice president and senior medical director of the NMDP, 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 Membership Review Committee.

Questions?

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