Cord Blood Protocol (10-CBA)
We are the sponsor of a research IND protocol which provides U.S. transplant centers access to unlicensed, minimally manipulated, cord blood units (CBUs) for FDA-specified disease indications.
- Resources for Transplant Centers: Access a list of qualified cord blood banks, 10-CBA study materials, 10-CBA electronic database information, including patient enrollment steps, event reporting information, center activation steps, and 10-CBA study file archives.
- Resources for Cord Blood Banks: Access information on MRQ, IDMs, product deviations, research protocol and consent forms.
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 (Opens in a new tab).
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 (Opens in a new tab) (XLS).
10-CBA Protocol
- 10-CBA Protocol (Opens in a new tab) - Version 10.4
- Protocol Signature Page (Opens in a new tab) – Version 10.4
- Record of Change (Opens in a new tab) - Version 10.4
- IRB Approval (Opens in a new tab) – 28 November 2022
- 10-CBA Study guides, materials, and templates are provided in the 10-CBA Study Materials (Opens in a new tab) 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 (Opens in a new tab) - Version 5.0
- Minor Information Sheet (Opens in a new tab) - Version 2.0
- Spanish Language Short-Form (Opens in a new tab) - Revision 2
10-CBA Electronic Data Capture (EDC) Systems
- Medidata RAVE: 10-CBA CRF Completion Guidelines (Opens in a new tab) (CCGs) - Version 2.0
- FormsNet3: CIBMTR Forms Instruction Manual (Opens in a new tab) - 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 (Opens in a new tab) and FormsNet3 (Opens in a new tab).
- Medidata RAVE: 10-CBA CRF Completion Guidelines (Opens in a new tab) (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:
- FormsNet3: CIBMTR Forms Instruction Manual (Opens in a new tab) - Last update: Oct 30, 2023
- Access to FormsNet3 is maintained by the CIBTMR Center Support (Opens in a new tab). 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:
-
Obtain patient consent/assent.
-
Complete both the Demographics form and Inclusion/Exclusion Screening form in Medidata Rave®.
- 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 (Opens in a new tab), instructions (Opens in a new tab) and quick reference guide (Opens in a new tab).
- Product complaint form. View sample form (Opens in a new tab) (PDF), instructions (Opens in a new tab) and quick reference guide (Opens in a new tab) (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.
- 10-CBA Protocol (Opens in a new tab) - Version 10.4
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 (Opens in a new tab) (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 (Opens in a new tab) 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 (Opens in a new tab). Please note that study materials can be found on the 10-CBA Study Page.
- 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
- 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 (Opens in a new tab), NMDP documentation of IND number (Opens in a new tab) (PDF) and 10-CBA Background Memo (Opens in a new tab) (PDF)
- Submit Completed Participation Agreement Amendment
- Participation Agreement Amendment provided by the NMDP contracts department
- Submit Remaining Enrollment Materials as Available Center Documentation
Center Documentation
- FDA Form 1572 (Opens in a new tab)
- OHRP Federalwide Assurance (FWA) Documentation
- 10-CBA Study Delegation of Authority Log (Opens in a new tab) – Revision 3:
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 (Opens in a new tab)
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
- Submit Preliminary Activation Documents
Transplant centers continue to enroll patients and access unlicensed cord blood units (CBUs) under the 10-CBA (Opens in a new tab) (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
- Complete the latest version of the Maternal Risk Questionnaire (MRQ) and Infectious Disease Marker (IDM) forms (gap analysis), at the time of request
- Confirm eligibility and licensure status in CordSource™
- 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 (Opens in a new tab) (PDF)
- Cord blood consent form template (Opens in a new tab) (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 (Opens in a new tab).
Questions?
Contact the Cord Blood Bank Liaisons at cordliaisons@nmdp.org.
10-CBA Protocol Archive
Archived copies of all versions of the 10-CBA protocols.
- Version 10.4 (Opens in a new tab) (current)
- Version 10.3 (Opens in a new tab)
- Version 10.2 (Opens in a new tab)
- Version 10.1 (Opens in a new tab)
- Version 10.0 (Opens in a new tab)
- Version 9 (Opens in a new tab)
- Version 8 (Opens in a new tab)
- Version 7 (Opens in a new tab)
- Version 6 (Opens in a new tab) – March 15, 2013 through March 14, 2014
- Version 6 (Opens in a new tab) – September 26, 2013 through March 14 2014
- Version 5 (Opens in a new tab)
- Version 4 (Opens in a new tab)
- Version 3 (Opens in a new tab)
- Protocol (v10.4) Record of Change (Opens in a new tab)
- Protocol (v10.3) Record of Change (Opens in a new tab)
- Protocol (v10.2), Consent (v5.0), Minor Information Sheet (v2.0), and Investigator’s Brochure (r8) Record of Change (Opens in a new tab)
- Protocol (v10.1) and Investigator’s Brochure (r7) Record of Change (Opens in a new tab)
- Protocol (v10.0) and Investigator’s Brochure (r6) Record of Change (Opens in a new tab)
- Protocol (v9) Record of Change (Opens in a new tab)
- Protocol (v8) Record of Change (Opens in a new tab)
- Protocol (v7), Consent (v4), and Investigator Brochure (r5) Record of Change (Opens in a new tab) – June 2, 2014
- Protocol (v7), Consent (v4), and Investigator Brochure (r5) Record of Change (Opens in a new tab) – May 14, 2014
- Protocol (v6), Consent (v3), and Investigator Brochure (r4) Record of Change (Opens in a new tab)
- Protocol (v5) and Investigator Brochure (r3) Record of Change (Opens in a new tab)
- Protocol (v4), Consent (v2), and Investigator Brochure (r2) Record of Change (Opens in a new tab)
10-CBA Protocol IRB Archive
Archived copies of the IRB approvals for the 10-CBA protocol.
- IRB Approval – May 12, 2023 (Opens in a new tab)
- IRB Approval – November 28, 2022 (Opens in a new tab)
- IRB Approval – June 16, 2022 (Opens in a new tab)
- IRB Approval – July 30, 2021 (Opens in a new tab)
- IRB Approval – August 20, 2020 (Opens in a new tab)
- IRB Approval – September 21, 2019 (Opens in a new tab)
- IRB Approval – November 13, 2018 (Opens in a new tab)
- IRB Approval – December 21, 2017 (Opens in a new tab)
- IRB Approval – December 15, 2016 (Opens in a new tab)
- IRB Approval – December 21, 2015 (Opens in a new tab)
- IRB Approval – January 15, 2015 (Opens in a new tab)
- IRB Approval – June 2, 2014 (Opens in a new tab)
- IRB Approval – May 16, 2014 (Opens in a new tab)
- IRB Approval – February 21, 2014 (Opens in a new tab)
- IRB Approval – September 30, 2013 (Opens in a new tab)
- IRB Approval – March 11, 2013 (Opens in a new tab)
- IRB Approval – March 21, 2012 (Opens in a new tab)
- Initial Submission IRB Approval – April 21, 2011 (Opens in a new tab)
10-CBA Protocol DPSM Letter Archive
Archived copies of the Donor and Patient Safety Monitoring (DPSM) Advisory Group Letters for the 10-CBA protocol.
- DPSM Letter - August 29, 2023 (Opens in a new tab) (May 2, 2023 through August 29, 2023)
- DPSM Letter - May 2, 2023 (Opens in a new tab) (February 21, 2023 through May 2, 2023)
- DPSM Letter - February 21, 2023 (Opens in a new tab) (November 29, 2022 through February 21, 2023)
- DPSM Letter - November 29, 2022 (Opens in a new tab) (August 13, 2022 through November 29, 2022)
- DPSM Letter - September 1, 2022 (Opens in a new tab) (June 1, 2022 through August 12, 2022)
- DPSM Letter - July 15, 2022 (Opens in a new tab) (March 1, 2022 through May 31, 2022)
- DPSM Letter - March 1, 2022 (Opens in a new tab) (November 13, 2021 through February 28, 2022)
- DPSM Letter - February 17, 2022 (Opens in a new tab) (August 3, 2021 through November 12, 2021)
- DPSM Letter - August 2, 2021 (Opens in a new tab) (May 25, 2021 through August 2, 2021)
- DPSM Letter - May 24, 2021 (Opens in a new tab) (February 2, 2021 through May 24, 2021)
- DPSM Letter - February 1, 2021 (Opens in a new tab) (November 14, 2020 through February 1, 2021)
- DPSM Letter - November 13, 2020 (Opens in a new tab) (August 26, 2020 through November 13, 2020)
- DPSM Letter - August 25, 2020 (Opens in a new tab) (May 22, 2020 through August 25, 2020)
- DPSM Letter - May 21, 2020 (Opens in a new tab) (November 2, 2019 through May 21, 2020)
- DPSM Letter - January 6, 2020 (Opens in a new tab) (February 8, 2019 through November 1, 2019)
- DPSM Letter - February 8, 2019 (Opens in a new tab) (November 3, 2018 through February 8, 2019)
- DPSM Letter - November 12, 2018 (Opens in a new tab) (May 5, 2018 through November 2, 2018)
- DPSM Letter - May 21, 2018 (Opens in a new tab) (December 16, 2017 through May 4, 2018)
- DPSM Letter - January 16, 2018 (Opens in a new tab) (January 1, 2017 through December 15, 2017)
- DPSM Letter - January 4, 2017 (Opens in a new tab) (May 6, 2016 through December 31, 2016)
- DPSM Letter - May 16, 2016 (Opens in a new tab) (October 1, 2015 through May 5, 2016)
- DPSM Letter - November 17, 2015 (Opens in a new tab) (December 13, 2014 through October 16, 2015)
- DPSM Letter - January 20, 2015 (Opens in a new tab) (May 1, 2014 through December 12, 2014)
- DPSM Letter - May 28, 2014 (Opens in a new tab) (October 29, 2013 through April 30, 2014)
- DPSM Letter - November 13, 2013 (Opens in a new tab) (April 1, 2013 through October 28, 2013)
- DPSM Letter - May 31, 2013 (Opens in a new tab) (October 1, 2012 through March 31, 2013)
- DPSM Letter – January 10, 2013 (Opens in a new tab) (April 1, 2012 through September 30, 2012)
- DPSM Letter - May 17, 2012 (Opens in a new tab) (October 1, 2011 through March 31, 2012)
10-CBA IND and FDA Annual Reports
Archived copies of the IND Annual Reports and FDA Safety Report Letters for the 10-CBA protocol.
- Annual Report - July 1, 2021 through June 30, 2022 (Opens in a new tab)
- Annual Report - July 1, 2020 through June 30, 2021 (Opens in a new tab)
- Annual Report - July 1, 2019 through June 30, 2020 (Opens in a new tab)
- Annual Report - July 1, 2018 through June 30, 2019 (Opens in a new tab)
- Annual Report - July 1, 2017 through June 30, 2018 (Opens in a new tab)
- Annual Report - July 1, 2016 through June 30, 2017 (Opens in a new tab)
- Annual Report - July 1, 2015 through June 30, 2016 (Opens in a new tab)
- Annual Report - July 1, 2014 through June 30, 2015 (Opens in a new tab)
- Annual Report - July 1, 2013 through June 30, 2014 (Opens in a new tab)
- Annual Report - July 1, 2012 through June 30, 2013 (Opens in a new tab)
- Annual Report - January 1, 2012 through June 30, 2012 (Opens in a new tab)
- Annual Report - October 1, 2011 through December 31, 2011 (Opens in a new tab)
- FDA Safety Report Letter - February 25, 2014 (Opens in a new tab)
- FDA Safety Report Letter - July 16, 2013 (Opens in a new tab)
- FDA Safety Report Letter - March 27, 2013 (Opens in a new tab)
10-CBA Protocol Memo Archive
- Consent Process Documentation in the Subject Medical Record Memo - August 24, 2023 (Opens in a new tab)
- Good Clinical Practice (GCP) Certifications prior to 2017 - July 6, 2023 (Opens in a new tab)
- DPSM AE Reports - July 3, 2023 (Opens in a new tab)
- 10-CBA and IND16909 (CHEERS Protocol) - October 3, 2018 (Opens in a new tab)
- Study subject eligibility when consent obtained after study enrollment - October 31, 2014 (Opens in a new tab)
- Non-Substantive changes to 10-CBA protocol v10.2 - November 19, 2018 (Opens in a new tab)
- Non-Substantive changes to 10-CBA protocol v10.1 - January 19, 2018 (Opens in a new tab)
- Non-Substantive changes to 10-CBA protocol v9.0 - March 15, 2016 (Opens in a new tab)
- Non-Substantive changes to 10-CBA protocol v7.0 - August 4, 2015 (Opens in a new tab)
- Non-substantive changes to 10-CBA study protocol v5.0 - March 11, 2013 (Opens in a new tab)
- PI Letter - Annual Report - July 1, 2017 through June 30, 2018 (Opens in a new tab)
- PI Letter - Annual Report - July 1, 2016 through June 30, 2017 (Opens in a new tab)
- PI Letter - Annual Report - July 1, 2015 through June 30, 2016 (Opens in a new tab)
- PI Letter - Annual Report - July 1 2014 through June 30, 2015 (Opens in a new tab)
- PI Letter - Annual Report - July 1, 2013 through June 30, 2014 (Opens in a new tab)
- PI Letter - Annual Report - January 1, 2012 through June 30, 2012 (Opens in a new tab)
- DPSM Letter Memo - October 6, 2023 (Opens in a new tab)
- DPSM Letter Memo - March 14, 2023 (Opens in a new tab)
- DPSM Letter Memo - September 29, 2022 (Opens in a new tab)
- DPSM Letter Memo - May 4, 2022 (Opens in a new tab)
- DPSM Letter Memo - March 8, 2022 (Opens in a new tab)
- DPSM Letter Memo - August 3, 2021 (Opens in a new tab)
- DPSM Letter Memo - June 10, 2021 (Opens in a new tab)
- DPSM Letter Memo - March 2, 2021 (Opens in a new tab)
- DPSM Letter Memo - January 12, 2021 (Opens in a new tab)
- DPSM Letter Memo - November 2, 2020 (Opens in a new tab)
- DPSM Letter Memo - May 17, 2016 (Opens in a new tab)
- DPSM Letter Memo - November 18, 2015 (Opens in a new tab)
- DPSM Letter Memo - January 19, 2015 (Opens in a new tab)
- DPSM Letter Memo - November 15, 2013 (Opens in a new tab)
- DPSM Letter Memo - June 5, 2013 (Opens in a new tab)
- 10-CBA IND Number Letter - February 7, 2019 (Opens in a new tab)
- 10-CBA IND Number Letter - June 9, 2011 (Opens in a new tab)
- NMDP IRB Continuing Review Approval Memo - August 28, 2020 (Opens in a new tab)
- NMDP IRB Continuing Review Approval and DPSM Letter Memo - June 2, 2014 (Opens in a new tab)
- 10-CBA Study Communications: New centralized email address Memo - January 21, 2020 (Opens in a new tab)
- New 10-CBA Study Page (Study Synopsis and Study Materials content) Memo - July 29, 2016 (Opens in a new tab)
- New Transplant form in Medidata Rave Memo - March 23, 2016 (Opens in a new tab)
- 10-CBA study-specific forms now live in RAVE Memo - March 7, 2016 (Opens in a new tab)
- Electronic Data Capture (EDC) system transition update for 10-CBA study-specific forms Memo - February 9, 2016 (Opens in a new tab)
- Upcoming Electronic Data Capture (EDC) System Transition for 10-CBA study-specific forms - January 7, 2016 (Opens in a new tab)
- Reminder: NMDP IRB authorization agreement available for 10-CBA study Memo - October 5, 2015 (Opens in a new tab)
- Delegation of Authority Log Clarification Memo - May 4, 2015 (Opens in a new tab)
- Delegation of Authority Log Memo - February 17, 2015 (Opens in a new tab)