IRB Study Number 12-780
Status Recruiting
Phase Phase 2
Location Cleveland Clinic Main Campus
Institute Taussig Cancer Institute
Description
Primary
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.
SecondaryAssess incidence of transmission of infections
- Assess incidence of graft rejection
- Assess incidence of neutrophil engraftment > 500 /ul
- Determine 1 year survival after cord blood transplantation
- Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
- Assess cumulative incidence of chronic GVHD
- Determine platelet engraftment of > 20,000 and > 50,000/ul
- Determine CBU-derived engraftment
Inclusion Criteria
- Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.
- Patients of any age and either gender
- HPC-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 CB products (only)
- Patients who are receiving unlicensed CB products from other CB banks (only)
- Patients who are transplanted at non-US transplant centers
- Patients who are receiving CB products that will be manipulated post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)
