Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders
Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders
This is a study to evaluate the safety and efficacy of Miltenyi CliniMACS® CD34 Reagent
 System to promote engraftment of haploidentical CD34+ selected cells combined with single
 unit umbilical cord blood transplant for treatment of high-risk hematologic disorders.
In this clinical protocol, the CliniMACS® CD34 Reagent System will be used for processing
 hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic,
 HLA-haploidentical, related donor to obtain a CD34+ cell-enriched population for
 hematopoietic reconstitution. The haploidentical donor will be mobilized by G-CSF and undergo
 one apheresis to collect CD34+ stem cells. The products will be cryopreserved until the time
 of transplantation. Recipients with hematologic disorders who require transplant will receive
 a standard conditioning regimen and will receive an allograft on day 0 containing donor CD34+
 cells that have been positively selected and T-cell depleted following G-CSF mobilization
 combined with a single UCB unit.
Inclusion Criteria - Recipient

 -  Ages 18-80 years inclusive

 -  Diagnosed with high risk hematologic disorders warranting stem cell transplant per
 institutional standard of care

 -  Lack HLA-identical related donor

 -  Availability of at least one HLA- haploidentical (i.e. => 5/10 and <= 8/10 HLA match)
 related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells.

 -  Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit
 from the National Marrow Donor Program (NMDP). The cord blood unit must contain a
 minimum TNC (prior to thawing) of at least 2x107 cells per kilogram of recipient body
 weight

 -  Ability to comprehend the nature of the treatment 6.2. Exclusion Criteria - Recipient
 (any of the following)

 -  HLA identical (6/6) related donor available and readily accessible at time of
 transplantation evaluation

 -  Any patient not meeting institutional standard guidelines for transplant eligibility