Phase I Study of Umbilical Cord Blood Transplantation Followed by Third Party Thymus Transplantation
The objective of this trial is to assess the toxicity of thymus transplantation following
unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events
that are not typically associated with umbilical cord blood transplantation. Also, to
determine whether engraftment of a third party thymus allograft is feasible in patients who
have undergone unrelated umbilical cord blood transplantation. Thymic engraftment will be
determined by biopsy of the thymus allograft and immunohistochemical evidence of
thymopoiesis. In addition, we would like to assess thymic function by measuring the number
of naive T cells and the number of T cell receptor rearrangement excision circles (TRECS),
and by assessing the diversity of the T cell receptor beta chain. These data will be
compared to age, stem-cell donor source and disease matched historical controls whose stem
cell transplants were not followed by a thymus transplant. This will be done in descriptive
fashion. Other immune parameters will be followed including T, B, and NK cell numbers, T
cell responses to mitogens, antigens, and immunoglobulin production.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity of thymus transplantation following unrelated umbilical cord blood transplantation. Emphasis will be placed on adverse events that are not typically associated with umbilical cord blood transplantation.
5 years
Yes
Mitchell Horwitz, MD
Principal Investigator
Duke University Health System
United States: Food and Drug Administration
Pro00007995
NCT00597441
November 2005
May 2010
Name | Location |
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Duke University Health System | Durham, North Carolina 27705 |