About this trial
This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
Patients: Patients of any age and either gender
Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)
Disqualifiers
Patients who are receiving licensed cord blood products (only)
Patients who are receiving unlicensed cord blood products from other banks (only)
Patients who are transplanted at non-US transplant centers
Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
Trial design
Single group
Treatments tested in this trial
unlicensed CBU
Biological/Vaccineinfusion of unlicensed cord blood units
Treatment groups
Trial outcomes
Primary outcomes
Incidence of infusion-related reactions
The primary aim of this study is to examine the safety of administration of the unlicensed investigational cord blood products in a multi-institution setting. The study will evaluate prospectively the incidence of serious adverse reactions as well as the incidence of all infusion related reactions after administration of the unlicensed, investigational NCBP cord blood units.
Secondary outcomes
engraftment
This outcome will evaluate engraftment of unlicensed cord blood units
Sponsors and contacts
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