Phoenix Children’s Hospital Research
Institute (PCRI) Website Clinical Trial Listing
** Please complete and return to Shy Walker at
swalker@phoenixchildrens.com
Study Title: Safety Study of Unlicensed, Investigational Cord Blood Units Manufactured by the NCBP for
Unrelated Transplantation
Study Purpose (2-3 sentences in laymen terms):
This study will evaluate the safety of infusion of the investigational cord blood units by carefully
documenting all infusion-related problems.
Study Summary (1 paragraph in laymen terms):
The primary aim of this study is to examine the safety of administration of the unlicensed investigational
NCBP HPC-CORD BLOOD products in a multi-institution setting. Therefore, 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 CBU.
Definitions of Infusion-related adverse reactions:
Mild - Moderate: reactions during or after the infusion of the CB product that require some medical
intervention but do not affect the overall patient status or outcome.
Severe: serious, life-threatening or fatal infusion reactions, requiring major medical intervention. These
include: anaphylactic shock, acute cardiac, pulmonary or renal failure, seizures, patient transfer to the
Intensive Care Unit, or death within 48 hours of the CB infusion. Adverse Reactions will also be classified by
grade, according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Basic Eligibility Criteria (1 paragraph in laymen terms):
Inclusion Criteria:
1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired,
or result from myeloablative treatment.
2. Patients: Patients of any age and either gender
3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one
units)
Exclusion Criteria:
1. Patients who are receiving licensed cord blood products (only)
2. Patients who are receiving unlicensed cord blood products from other banks (only)
3. Patients who are transplanted at non-US transplant centers
4. Patients who are receiving cord blood products that will be "manipulated" post-thaw (e.g., ex vivo
expansion, incubation in vitro, etc.)
Study Location(s):
Phoenix Children’s Hospital
Study Contact(s):
Alan Holzkopf, CCRC
aholzkopf@phoenixchildrens.com