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Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for Unrelated Transplantation

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This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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)
Exclusion Criteria:

• 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.)

Biological: unlicensed CBU

Infusion Reactions

cord blood, transplantation, stem cells, adverse event

Dorothy Sung - dsung@nybc.org
McCarty, John, M.
Phase 2
HM14815
NCT01656603
See this study on ClinicalTrials.gov

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