Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
A New Approach to Improve Long-term Hematopoietic Recovery After Allogeneic Umbilical Cord Blood Transplantation in Children - Intrabone Infusion of Umbilical Cord Blood Stem Cells
The purpose of this study is to determine if the method of intrabone infusion of hematologic stem cells can increase and accelerate hematopoietic reconstitution after umbilical cord blood transplantation in pediatric patients.
Umbilical cord blood transplantation (UCBT) has been increasingly used to treat malignant and
non-malignant haematological, immunodeficiency and some metabolic diseases. UCBT offers the
advantages of easy procurement, no risk to donors, a reduced risk of transmitting infections,
immediate availability of cryopreserved units, and acceptable partial HLA mismatches.
However, patients treated with UCBT show delayed hematopoietic and immunological recoveries,
have higher rates of infection, and relapse from the original malignant disease, which can
all lead to life threatening problems. UCBT can also result in a higher rate of graft failure
compared to other hematopoietic stem cell transplantation (HSCT) sources. The problem of a
slower hematopoietic recovery post-UCBT has been addressed using a number of different
approaches in adult patients.In adults, use of intrabone injection of cord blood results in a
faster hematopoietic recovery in a phase II study. However, there is no clinical trial in
pediatric patients.
This study is addressed to determine if a change in the cord blood stem cell infusion method
can increase and accelerate hematopoietic reconstitution after UCBT in pediatric patients.
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