Cord Blood Protocol (10-CBA)

1U.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, 10-CBA study materials, 10-CBA electronic database information, including patient enrollment steps, and event reporting information, center activation steps, and 10-CBA study file archives. 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).

10-CBA Protocol

• 10-CBA Protocol - Version 10.4
  • Protocol Signature Page – Version 10.4
  • Record of Change - Version 10.4
• IRB Approval – 28 November 2022
• 10-CBA Study guides, materials, and templates are provided in the 10-CBA Study Materials page in the 10-CBA Archives.

10-CBA Informed Consent Form (ICF) Templates

The study sponsor, NMDP, provides templates for Recipient Informed Consent Form, Minor Information Sheet, and Spanish Language Short-Form for the 10-CBA protocol. These templates must be approved by the 10-CBA study team and NMDP IRB or local IRB prior to obtaining consent.

• 10-CBA Informed Consent Form - Version 5.0
  • Minor Information Sheet - Version 2.0
  • Spanish Language Short-Form - Revision 2

10-CBA Electronic Data Capture (EDC) Systems

• Medidata RAVE: 10-CBA CRF Completion Guidelines (CCGs) - Version 2.0
• FormsNet3: CIBMTR Forms Instruction Manual - Last update: Oct 30, 2023
• 10-CBA EDC Instructions:
  • Enrolling a Patient
  • Event Reporting

10-CBA Archives

• 10-CBA Protocol Archive: Archived copies of all versions of the 10-CBA cord blood unit protocols
• 10-CBA Protocol IRB Archive: Archived copies of the IRB approvals for all the 10-CBA protocols.
• 10-CBA Protocol DPSM Letter Archive: Archived copies of Donor and Patient Safety Monitoring (DPSM) Advisory Group letters for the 10-CBA protocol.
• 10-CBA IND and FDA Annual Reports: Archived copies of correspondence with the FDA related to the 10-CBA Investigational New Drug (IND) Application and Protocol.
• 10-CBA Protocol Memo Archive: Archived copies of memos and note to files about the 10-CBA protocol.

10-CBA EDC Instructions

10-CBA study requires enrollment and data reporting in two separate electronic databases: Medidata RAVE and FormsNet3.

• Medidata RAVE: 10-CBA CRF Completion Guidelines (CCGs) - Version 2.0
  • To gain access to Medidata RAVE for the 10-CBA study, the center must provide an updated Delegation of Authority Log, GCP training, and the required 'Rave EDC Essentials for Clinical Research Coordinators' eLearning in Medidata Rave®. 
  • EDC Instruction Manuals:
    • 10-CBA Protocol Guidance
    • 10-CBA Accessing Medidata RAVE
    • 10-CBA Inclusion Exclusion Form Drop Down Menu Tips
• FormsNet3: CIBMTR Forms Instruction Manual - Last update: Oct 30, 2023
  • Access to FormsNet3 is maintained by the CIBTMR Center Support. Centers may submit tickets on their web page or call (763) 406-3411 or toll free (800) 526-7809 × 3411.

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:

1. Obtain patient consent/assent. 

2. Complete both the Demographics form and Inclusion/Exclusion Screening form in Medidata Rave®.

3. 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.
• Protocol deviation form.

10-CBA CRF Completion Guidelines (CCGs) are available at the top of the 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).

CIBMTR Forms Instructions Manual is available at the top of the page.

Questions?

For 10-CBA study questions, please contact 10-CBA@nmdp.org.

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
   10-CBA protocol, ICF templates, and study materials are available on Transplant Center Resources and 10-CBA Study Materials.
   • 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). 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

Center Documentation

• FDA Form 1572
• OHRP Federalwide Assurance (FWA) Documentation
• 10-CBA Study Delegation of Authority Log – Revision 3:
  Delegation of responsibility & staff signature log
  • Delegation of Authority Quick Guide – Version 2

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

Transplant centers continue to enroll patients and access unlicensed cord blood units (CBUs) under the 10-CBA (PDF) protocol. This page contains 10-CBA forms and resources for cord blood banks.

Are you a cord blood bank interested in participation? View our Cord Blood Bank Qualification and Membership page.

Forms and Reporting

1. Complete the latest version of the Maternal Risk Questionnaire (MRQ) and Infectious Disease Marker (IDM) forms (gap analysis), at the time of request
2. Confirm eligibility and licensure status in CordSource™
3. Report product deviations

Research Protocol and Consent Form Templates

Below are cord blood research protocol and consent form templates. These templates may be used as an option to consent maternal donors for the possibility that their CBU would be used for research purposes. A separate research consent may not be necessary if your bank has decided to incorporate research language into its standard collection consent form or if you do not make units available for research purposes.

• Cord blood research protocol template (PDF)
• Cord blood consent form template (DOC)

Submission to NMDP IRB

For those banks that plan to use the template materials and submit to the NMDP IRB, view IRB application information. Please contact the NMDP IRB if you have any questions about the submission process at IRBstaff@nmdp.org.

Questions?

Contact the Cord Blood Bank Liaisons at cordliaisons@nmdp.org.

• Version 10.4 (current)
• Version 10.3
• Version 10.2
• Version 10.1
• Version 10.0
• Version 9
• Version 8
• Version 7
• Version 6 – March 15, 2013 through March 14, 2014
• Version 6 – September 26, 2013 through March 14 2014
• Version 5
• Version 4
• Version 3

• Protocol (v10.4) Record of Change
• Protocol (v10.3) Record of Change
• Protocol (v10.2), Consent (v5.0), Minor Information Sheet (v2.0), and Investigator’s Brochure (r8) Record of Change
• Protocol (v10.1) and Investigator’s Brochure (r7) Record of Change
• Protocol (v10.0) and Investigator’s Brochure (r6) Record of Change
• Protocol (v9) Record of Change
• Protocol (v8) Record of Change
• Protocol (v7), Consent (v4), and Investigator Brochure (r5) Record of Change – June 2, 2014
• Protocol (v7), Consent (v4), and Investigator Brochure (r5) Record of Change – May 14, 2014
• Protocol (v6), Consent (v3), and Investigator Brochure (r4) Record of Change
• Protocol (v5) and Investigator Brochure (r3) Record of Change
• Protocol (v4), Consent (v2), and Investigator Brochure (r2) Record of Change

• IRB Approval – May 12, 2023
• IRB Approval – November 28, 2022
• IRB Approval – June 16, 2022
• IRB Approval – July 30, 2021
• IRB Approval – August 20, 2020
• IRB Approval – September 21, 2019
• IRB Approval – November 13, 2018
• IRB Approval – December 21, 2017
• IRB Approval – December 15, 2016
• IRB Approval – December 21, 2015
• IRB Approval – January 15, 2015
• IRB Approval – June 2, 2014
• IRB Approval – May 16, 2014
• IRB Approval – February 21, 2014
• IRB Approval – September 30, 2013
• IRB Approval – March 11, 2013
• IRB Approval – March 21, 2012
• Initial Submission IRB Approval – April 21, 2011

• DPSM Letter - August 29, 2023 (May 2, 2023 through August 29, 2023)
• DPSM Letter - May 2, 2023 (February 21, 2023 through May 2, 2023)
• DPSM Letter - February 21, 2023 (November 29, 2022 through February 21, 2023)
• DPSM Letter - November 29, 2022 (August 13, 2022 through November 29, 2022)
• DPSM Letter - September 1, 2022 (June 1, 2022 through August 12, 2022)
• DPSM Letter - July 15, 2022 (March 1, 2022 through May 31, 2022)
• DPSM Letter - March 1, 2022 (November 13, 2021 through February 28, 2022)
• DPSM Letter - February 17, 2022 (August 3, 2021 through November 12, 2021)
• DPSM Letter - August 2, 2021 (May 25, 2021 through August 2, 2021)
• DPSM Letter - May 24, 2021 (February 2, 2021 through May 24, 2021)
• DPSM Letter - February 1, 2021 (November 14, 2020 through February 1, 2021)
• DPSM Letter - November 13, 2020 (August 26, 2020 through November 13, 2020)
• DPSM Letter - August 25, 2020 (May 22, 2020 through August 25, 2020)
• DPSM Letter - May 21, 2020 (November 2, 2019 through May 21, 2020)
• DPSM Letter - January 6, 2020 (February 8, 2019 through November 1, 2019)
• DPSM Letter - February 8, 2019 (November 3, 2018 through February 8, 2019)
• DPSM Letter - November 12, 2018 (May 5, 2018 through November 2, 2018)
• DPSM Letter - May 21, 2018 (December 16, 2017 through May 4, 2018)
• DPSM Letter - January 16, 2018 (January 1, 2017 through December 15, 2017)
• DPSM Letter - January 4, 2017 (May 6, 2016 through December 31, 2016)
• DPSM Letter - May 16, 2016 (October 1, 2015 through May 5, 2016)
• DPSM Letter - November 17, 2015 (December 13, 2014 through October 16, 2015)
• DPSM Letter - January 20, 2015 (May 1, 2014 through December 12, 2014)
• DPSM Letter - May 28, 2014 (October 29, 2013 through April 30, 2014)
• DPSM Letter - November 13, 2013 (April 1, 2013 through October 28, 2013)
• DPSM Letter - May 31, 2013 (October 1, 2012 through March 31, 2013)
• DPSM Letter – January 10, 2013 (April 1, 2012 through September 30, 2012)
• DPSM Letter - May 17, 2012 (October 1, 2011 through March 31, 2012)

• Annual Report - July 1, 2021 through June 30, 2022
• Annual Report - July 1, 2020 through June 30, 2021
• Annual Report - July 1, 2019 through June 30, 2020
• Annual Report - July 1, 2018 through June 30, 2019
• Annual Report - July 1, 2017 through June 30, 2018
• Annual Report - July 1, 2016 through June 30, 2017
• Annual Report - July 1, 2015 through June 30, 2016
• Annual Report - July 1, 2014 through June 30, 2015
• Annual Report - July 1, 2013 through June 30, 2014
• Annual Report - July 1, 2012 through June 30, 2013
• Annual Report - January 1, 2012 through June 30, 2012
• Annual Report - October 1, 2011 through December 31, 2011
• FDA Safety Report Letter - February 25, 2014
• FDA Safety Report Letter - July 16, 2013
• FDA Safety Report Letter - March 27, 2013

• Consent Process Documentation in the Subject Medical Record Memo - August 24, 2023
• Good Clinical Practice (GCP) Certifications prior to 2017 - July 6, 2023
• DPSM AE Reports - July 3, 2023
• 10-CBA and IND16909 (CHEERS Protocol) - October 3, 2018
• Study subject eligibility when consent obtained after study enrollment - October 31, 2014
• Non-Substantive changes to 10-CBA protocol v10.2 - November 19, 2018
• Non-Substantive changes to 10-CBA protocol v10.1 - January 19, 2018
• Non-Substantive changes to 10-CBA protocol v9.0 - March 15, 2016
• Non-Substantive changes to 10-CBA protocol v7.0 - August 4, 2015
• Non-substantive changes to 10-CBA study protocol v5.0 - March 11, 2013

• PI Letter - Annual Report - July 1, 2017 through June 30, 2018
• PI Letter - Annual Report - July 1, 2016 through June 30, 2017
• PI Letter - Annual Report - July 1, 2015 through June 30, 2016
• PI Letter - Annual Report - July 1 2014 through June 30, 2015
• PI Letter - Annual Report - July 1, 2013 through June 30, 2014
• PI Letter - Annual Report - January 1, 2012 through June 30, 2012
• DPSM Letter Memo - October 6, 2023
• DPSM Letter Memo - March 14, 2023
• DPSM Letter Memo - September 29, 2022
• DPSM Letter Memo - May 4, 2022
• DPSM Letter Memo - March 8, 2022
• DPSM Letter Memo - August 3, 2021
• DPSM Letter Memo - June 10, 2021
• DPSM Letter Memo - March 2, 2021
• DPSM Letter Memo - January 12, 2021
• DPSM Letter Memo - November 2, 2020
• DPSM Letter Memo - May 17, 2016
• DPSM Letter Memo - November 18, 2015
• DPSM Letter Memo - January 19, 2015
• DPSM Letter Memo - November 15, 2013
• DPSM Letter Memo - June 5, 2013
• 10-CBA IND Number Letter - February 7, 2019
• 10-CBA IND Number Letter - June 9, 2011
• NMDP IRB Continuing Review Approval Memo - August 28, 2020
• NMDP IRB Continuing Review Approval and DPSM Letter Memo - June 2, 2014
• 10-CBA Study Communications: New centralized email address Memo - January 21, 2020
• New 10-CBA Study Page (Study Synopsis and Study Materials content) Memo - July 29, 2016
• New Transplant form in Medidata Rave Memo - March 23, 2016
• 10-CBA study-specific forms now live in RAVE Memo - March 7, 2016
• Electronic Data Capture (EDC) system transition update for 10-CBA study-specific forms Memo - February 9, 2016
• Upcoming Electronic Data Capture (EDC) System Transition for 10-CBA study-specific forms - January 7, 2016
• Reminder: NMDP IRB authorization agreement available for 10-CBA study Memo - October 5, 2015
• Delegation of Authority Log Clarification Memo - May 4, 2015
• Delegation of Authority Log Memo - February 17, 2015