Haploidentical CD34+ Selected Cells Combined With Single Unit Umbilical Cord Blood Transplant for Treatment of High-risk Hematologic Disorders



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - 80
Updated:10/7/2018
Start Date:October 12, 2017
End Date:February 10, 2022
Contact:Constance Gorden
Email:CONSTANCE.GORDEN@UCDENVER.EDU
Phone:303-724-8649

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Safety and Efficacy of Miltenyi CliniMACS® CD34 Reagent System for Transplant Protocol Utilizing 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 Eligibility

- Ages 18-80 years inclusive

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

- Lack HLA-identical related donor

- Availability of at least one HLA- haploidentical (i.e. greater than or equal to 5/10
and less than or equal to 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

Exclusion Criteria:

- 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
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Enkhtsetseg Purev, MD, PhD
Phone: 303-724-8649
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Aurora, CO
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