Transplant Center Resources
U.S. transplant centers can participate in our 10-CBA study protocol to access unlicensed, minimally manipulated, cord blood units (CBUs) for FDA-specified disease indications. On this page, you will find a list of qualified cord blood banks, patient enrollment steps, and event reporting information. Additional resources may be found on our 10-CBA Study Page.
Not yet participating in the protocol? See how to activate your center.
Qualified Cord Blood Banks
To facilitate access to a CBU under the 10-CBA protocol, the CBU must be provided by a cord blood bank qualified to participate under the 10-CBA IND. View list of qualified cord blood banks (XLS).
Enrolling a Patient
For patients undergoing transplant using unlicensed CBUs and at least one cord that will be procured using the NMDP IND, enrollment in the 10-CBA study is required prior to CBU shipment. All participants in this access and distribution protocol must provide informed consent and, if applicable, assent prior to study enrollment. Please contact 10-CBA@nmdp.org to request access.
If a previously-enrolled participant requires a subsequent transplant using unlicensed CBUs and at least one cord is procured under the NMDP IND, the patient must be re-consented and re-enrolled in the study prior to CBU shipment.
To successfully enroll a patient in the 10-CBA study, you must complete both the Demographics form and Inclusion/Exclusion Screening form in Medidata Rave®. You will need access to the 10-CBA study in Medidata Rave®to enroll patients and complete other 10-CBA study-specific report forms. Please contact 10-CBA@nmdp.org to request access.
To enroll your patient:
- Obtain patient consent/assent.
- Complete both the Demographics form and Inclusion/Exclusion Screening form in Medidata Rave®. Forms Instructions Manual may be found on our 10-CBA Study Page.
- When requesting the CBU(s), indicate NMDP as the IND sponsor on your shipment request.
Event Reporting
To report events for patients enrolled in 10-CBA, please use the following forms:
Medidata Rave
- Transplant form.
- Study exit form.
Forms Instructions Manual may be found on our 10-CBA Study Page.
FormsNet3
- Adverse event form. View sample form, instructions and quick reference guide.
- Product complaint form. View sample form (PDF), instructions and quick reference guide (PDF).
Training
Prior to having access to enroll patients on the 10-CBA study, site staff must first complete the required 'Rave EDC Essentials for Clinical Research Coordinators' eLearning in Medidata Rave®.
Questions?
For 10-CBA study questions, please contact 10-CBA@nmdp.org.