A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
S25.184.07
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Clinical Trial Information
Trial Contact: Frankos, Marie
Trial Phone: 321-842-8738
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IRB No: S25.184.07
Protocol Abbrev: 10-CBA
Principal Investigator: Rikin K. Shah, MD
Age Group: Pediatric; Adult
Treatment: Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
ClinicalTrials.gov ID: NCT01351545
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Objective
to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.
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Key Eligibility
-Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
-Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
-Pediatric and adult patients of any age
