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Safety Study of Cord Blood Units for Stem Cell Transplants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01861093
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : March 17, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
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) )

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 Biological: Cord Blood Units Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
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
Actual Study Start Date : October 16, 2015
Estimated Primary Completion Date : November 30, 2037
Estimated Study Completion Date : November 30, 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: 1
at least one
Biological: Cord Blood Units
cord blood units for transplants




Primary Outcome Measures :
  1. safety of administration of the unlicensed investigational NCBP HPC-CORD BLOOD products [ Time Frame: 1 year post transplant ]
    safety



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
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)

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
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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
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
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
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Principal Investigator: Richard W Childs, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01861093    
Other Study ID Numbers: 130116
13-H-0116
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: October 19, 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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:
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Preleukemia
Myelodysplastic Syndromes
Anemia, Aplastic
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Anemia
Bone Marrow Failure Disorders