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Safety Study of Cord Blood Units for Stem Cell Transplants

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ClinicalTrials.gov Identifier: NCT01861093
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : December 7, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background:

- Cord blood is blood that is taken from the umbilical cord and placenta of healthy newborns after childbirth. The cord blood collected from a baby is called a cord blood unit. Cord blood units are stored frozen in public cord blood banks. About 10,000 cord blood transplants have been performed in children and adults for blood cancers and other diseases in the world. These transplants have helped save lives and improve treatments. However, not all available units of cord blood have been collected, stored, and licensed according to specific government requirements. These unlicensed units can still be used in transplant, but they can only be given as part of specific research studies. This study will evaluate the safety of giving these unlicensed units by recording any problems that may occur during and after giving the cord blood.

Objectives:

- To test the safety and effectiveness of unlicensed cord blood units in people who need stem cell transplants.

Eligibility:

- Individuals who are scheduled to have a stem cell transplant.

Design:

  • Participants will be screened with a medical history and physical exam.
  • Participants will receive the cord blood unit as part of their stem cell transplant procedure. The transplant will be performed according to the current standard of care for the procedure.
  • After the transplant, participants will be monitored for up to 1 year. Any problems or side effects from the transplant will be treated as necessary. All outcomes will be reported to the National Cord Blood Program and to the Center for International Blood and Marrow Transplant.

Condition or disease Intervention/treatment Phase
Aplastic Anemia Leukemia Myelodysplastic Syndrome (MDS) Lymphoma Procedure: Cord Blood Units Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients
Study Start Date : May 21, 2013
Estimated Primary Completion Date : November 30, 2037
Estimated Study Completion Date : November 30, 2037


Arms and Interventions

Intervention Details:
    Procedure: Cord Blood Units
    Transplant

Outcome Measures

Primary Outcome Measures :
  1. Examine the safety of administration of the unlicensed investigational NCBP HPC-CORD Blood products [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients of any age or either gender with indications for receipt of investigational HPC-CORD BLOOD who are participating in an NIH-IRB approved clinical trial for unrelated hematopoietic stem cell transplantation.
  • Signed informed consent (and assent when applicable).

EXCLUSION CRITERIA:

  • Patients who are receiving licensed CB products (only)
  • Patients who are receiving unlicensed CB products from other CB banks (i.e. NMDP)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861093


Contacts
Contact: Jennifer S Wilder, R.N. (301) 451-3722 jw621w@nih.gov
Contact: Richard W Childs, M.D. (301) 451-7128 childsr@nhlbi.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Cord Blood Program, New York Blood Center
Investigators
Principal Investigator: Richard W Childs, M.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01861093     History of Changes
Other Study ID Numbers: 130116
13-H-0116
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: November 27, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Unrelated Hematopoietic Stem Cell Transplantation
Cryopreserved Cord Blood Units
National Cord Blood Program

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Anemia, Aplastic
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Anemia