Umbilical Cord Blood Transplantation From Unrelated Donors
University of Rochester
Summary
This study is being done to determine how long it takes for the engraftment (recovery of blood cell counts) of umbilical cord stem cells and also how often engraftment of umbilical cord stem cells transplanted from an unrelated donor fails. Another purpose will be to document the rate of disease-free survival and the rate of relapse (a return of your disease or syndrome) as well as the incidence and severity of graft versus host disease (GvHD) following cord blood stem cell transplantation. GvHD is a complication of stem cell transplants in which white blood cells from the transplanted tissue (graft) attack the transplant recipient's body (host).
Description
PRIMARY OBJECTIVES: I. Determine the kinetics of engraftment of umbilical cord blood (UCB) following transplantation into unrelated individuals. II. Determine the incidence of non-engraftment and secondary graft failure when unrelated donor UCB cells are administered to patients receiving myeloablative, reduced intensity cytoreductive, or non-ablative conditioning regimens together with immunosuppressive therapy. III. Determine the incidence and severity of graft-vs-host disease (GVHD) for patients receiving unrelated donor UCB grafts. IV. Document the overall survival, disease-free-surviv…
Eligibility
- Age range
- 0–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Appropriate diagnosis: Patients must have a disease or syndrome amenable to therapy with hematopoietic stem cell transplantation. Diagnoses include, but are not limited to: * Congenital and Other Non-malignant Disorders: * Immunodeficiency disorders (e.g. Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome) * Congenital hematopoietic stem cell defects (e.g. Chediak-Higashi Syndrome, Congenital Osteopetrosis, Osteogenesis Imperfecta) * Metabolic disorders (e.g. Hurler's Syndrome) * Severe aplastic anemia * High-Risk Leukemia: * Acute Myelogenous Leukemia * Refracto…
Interventions
- RadiationTotal Body Irradiation 1200 cGy
Total Body Irradiation 1200 cGy in 8 fractions
- RadiationTotal Body Irradiation 200 cGy
Total Body Irradiation 200 cGy in one fraction
- DrugCyclophosphamide
50 mg/kg or 60 mg/kg
- DrugMesna
50 mg/kg or 60 mg/kg plus 10% loading dose
- ProcedureCord Blood Infusion
Intravenous infusion of cord blood stem cells
- DrugBusulfan
0.8 mg/kg x 16 doses
- DrugFludarabine
Location
- Wilmot Cancer InstituteRochester, New York