Safety Study of Cord Blood Units for Stem Cell Transplants

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
National Cord Blood Program, New York Blood Center
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT01861093
First received: May 21, 2013
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Aplastic Anemia
Leukemia
Myelodysplastic Syndrome (MDS)
Lymphoma
Procedure: Cord Blood Units
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Examine the safety of administration of the unlicensed investigational NCBP HPC-CORD Blood products [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2013
Estimated Study Completion Date: November 2037
Estimated Primary Completion Date: November 2037 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cord Blood Units
    Transplant
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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:
No publications provided

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01861093     History of Changes
Other Study ID Numbers: 130116, 13-H-0116
Study First Received: May 21, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Unrelated Hematopoietic Stem Cell Transplantation
Cryopreserved Cord Blood Units
National Cord Blood Program

Additional relevant MeSH terms:
Anemia
Anemia, Aplastic
Leukemia
Lymphoma
Myelodysplastic Syndromes
Preleukemia
Hematologic Diseases
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 23, 2014