Hematologic Neoplasms Clinical Trial
Official title:
Cord Blood Transplantation in Adult Recipients
Umbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this procedure in adults. The purpose of this study is to examine the immune system response to cord blood stem cell transplantation in adults with advanced blood disorders or cancer.
The use of umbilical cord blood stem cells to treat blood disorders and cancer is an
important medical advance; currently, more than 45 disorders can be treated with this
method. While bone marrow transplants are the most common method for stem cell donations,
research has shown that there are many advantages to using allogeneic grafts of stem cells
obtained from umbilical cord blood. Cord blood stem cells are relatively easy to obtain.
Additionally, a perfect donor match is not necessary, thereby decreasing the likelihood of
graft-versus-host disease (GVHD), a serious side effect in which donor stem cells attack the
recipient's tissues. Cord blood has been used successfully in pediatric patients but its
benefit in adults remains untested. The purpose of this study is to evaluate the
effectiveness of umbilical cord blood stem cell transplantation in adults with advanced
blood disorders or cancer. Upon receiving an allogeneic stem cell transplant using umbilical
cord blood, participants will be observed for successful engraftment in which the
transplanted stem cells "take" and begin producing new blood cells. The incidence of GVHD
and the overall immune system's response will also be examined. In turn, these findings may
guide future umbilical cord blood stem cell clinical trials.
This 1-year study will enroll individuals with advanced blood diseases or cancer.
Participants will receive an allogeneic umbilical cord blood stem cell transplant and will
be closely monitored while in the hospital to determine when engraftment occurs and if GVHD
develops. Study visits will occur at Months 1, 2, 3, 6, 9, and Year 1. At each visit,
participants will have blood drawn for laboratory testing and for evaluation of immune
system response. Quality of life questionnaires will also be completed at each visit.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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