Activate Your Center

U.S. transplant centers are invited to participate in our IND protocol, 10-CBA, for access to unlicensed, minimally manipulated, cord blood units for FDA-specified disease indications. This protocol has been accepted by the FDA and approved by the NMDP IRB, and is open for patient enrollment. View cord blood transplantation scenarios guide (PDF). Sites have the option of submitting the study for IRB review to their local IRB or to the NMDP’s Single/Central IRB. The 10-CBA Study Team can assist sites in enrolling with the NMDP IRB.

To initiate the study at your site, complete the following steps. Send materials to the 10-CBA Study Team at 10-CBA@nmdp.org. Please note that study materials can be found on the 10-CBA Study Page.

1.Submit Preliminary Activation Documents

• Consent/assent forms
• Study Site Information Form

2.Submit Protocol, Consent Forms, and Investigator Brochure to Your IRB

• 10-CBA Protocol
• Consent/assent forms (approved by NMDP).  Please contact 10-CBA@nmdp.org to request these template documents. As a reminder, send your amended consent and assent forms in track changes format to 10-CBA Study Team for approval prior to IRB submission.
• Related documents for reference: Investigator Brochure, NMDP documentation of IND number (PDF) and 10-CBA Background Memo (PDF)

3.Submit Completed Participation Agreement Amendment

• Participation Agreement Amendment provided by the NMDP contracts department

4.Submit Remaining Enrollment Materials as Available

Center Documentation

• FDA Form 1572
• OHRP Federalwide Assurance (FWA) Documentation
• Study Log: Delegation of responsibility & staff signature log

Principal Investigator Documentation

• CV – signed & dated within past year
• Human Subjects Training Documentation
• Good Clinical Practice Training Documentation
• Current Medical License
• Financial Disclosure Form

Center IRB Documentation (keep original for your records)

• IRB Approval letter
• IRB Approved Informed Consent Form/Assent Form
• IRB Roster or Documentation of IRB composition in compliance with GCP

Send Materials to 10-CBA@nmdp.org

Keep a copy of all documents for your records. 

Questions?

Contact 10-CBA Study Team at 10-CBA@nmdp.org