The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and HPDSC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Infusions of thawed HPDSC to be given following UCB infusion.
Children's Hospital Colorado
Denver, Colorado, United States
New York Medical College
Valhalla, New York, United States
University of Utah
Salt Lake City, Utah, United States
Safety
to evaluate the safety of human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells in patients with malignant and non-malignant diseases.
Time frame: 100 days
donor chimerism
donor chimerism will be assessed at set timepoints
Time frame: 1 year
engraftment
Time frame: 1 year
Survival
Time frame: 100 days and 180 days
Relapse
Time frame: 100 days and 180 days
Mortality
Time frame: 1 year
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