Providing Access to Cord Blood Units for Transplants
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|ClinicalTrials.gov Identifier: NCT01479582|
Recruitment Status : Withdrawn
First Posted : November 24, 2011
Last Update Posted : December 21, 2018
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- Cord blood banks have been set up to collect and store umbilical cord blood for transplants. These transplants are used to treat different types of cancer. In October 2011, the Food and Drug Administration (FDA) began considering cord blood as a biological drug. Most of the cord blood units currently available in cord blood banks in the United States and other countries were collected before the FDA set these new standards. The units meet standards set by the National Marrow Donor Program (NMDP), but they were not collected, tested, or stored exactly according to FDA standards. As a result, the new guidelines state that they may only be used for transplant if the transplant is done as part of a study. Researchers have set up a study to provide these cord blood units to recipients and to study the effects of their use.
- To provide access to cord blood units for recipients whose best choice for a unit meets NMDP but not FDA standards.
- To study the effects of these cord blood transplants.
- Individuals who need to have a cord blood transplant to treat certain types of cancer.
- Participants will be screened with a physical exam, medical history. They will also have blood tests and imaging studies.
- Participants will have the cord blood transplant and allow their medical data to be collected by the study researchers.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelogous Leukemia/Other Leukemia Acute Leukemias MDS/MPS Multiple Myeloma Non-Hodgkin Lymphoma||Drug: Access to unlicensed cord blood units||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications|
|Study Start Date :||October 27, 2011|
|Actual Primary Completion Date :||November 26, 2012|
|Actual Study Completion Date :||November 26, 2012|
- The primary aim of this study is to examine the incidence of neutrophil recovery of greater than or equal to 500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licen...
- Assess incidence of graft rejection.
- Assess incidence of transmission of infection.
- Assess incidence of serious infusion reaction.
- Determine 1 year survival after cord blood transplantation.
- Assess cumulative incidence of aGVHD vs cGVHD.
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|Ages Eligible for Study:||up to 99 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA:
Patients with FDA-specified indications:
- Hematological malignancies
- Certain lysosomal storage and peroxisomal enzyme deficiency disorders
- Hurler syndrome (MPS I)
- Krabbe Disease (Globoid Leukodystrophy)
- X-linked Adrenoleukodystrophy
- Primary immunodeficiency diseases
- Bone marrow failure
- Signed informed consent (and signed assent, if applicable)
- Pediatric and adult patients of any age
- Patients who are receiving only licensed CBUs
- Cord blood transplant recipients at international transplant centers
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): NCT01479582
|Principal Investigator:||Ronald E Gress, M.D.||National Cancer Institute (NCI)|
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
|First Posted:||November 24, 2011 Key Record Dates|
|Last Update Posted:||December 21, 2018|
|Last Verified:||November 26, 2012|
Adult and Pediatric
Unlicensed Cord Blood Unit IND
Chronic Myelogenous Leukemia
Lysosomal Storage Diseases
Neoplasms by Histologic Type
Immune System Diseases
Neoplasms, Plasma Cell
Blood Protein Disorders