Georgia's Online Cancer Information Center

Find A Clinical Trial

Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation

Cancer Type
Unknown Primary
Trial Phase
Phase II
0 Years and older, Male and Female
Study Type
Protocol IDs
6637-01 (primary)
Study Sponsor
New York Blood Center


This study will evaluate the safety of infusion of the investigational cord blood units
by carefully documenting all infusion-related problems.


The primary aim of this study is to examine the safety of administration of the
unlicensed investigational NCBP hematopoietic progenitor cell-cord blood (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 cord blood (CB) product
that require some medical intervention but do not affect the overall patient status or

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).


  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)

Treatment Sites in Georgia

Northside Hospital Cancer Institute

1000 Johnson Ferry Road NE
Atlanta, GA 30342

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.