Human Placental-Derived Stem Cell Transplantation



Status:Active, not recruiting
Conditions:Cancer, Blood Cancer, Neurology, Anemia, Endocrine, Hematology, Metabolic
Therapuetic Areas:Endocrinology, Hematology, Neurology, Oncology, Pharmacology / Toxicology
Healthy:No
Age Range:Any - 55
Updated:12/24/2017
Start Date:April 2013
End Date:December 2019

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A Single-Arm Study to Assess the Safety of Transplantation With Human Placental-Derived Stem-Cells Combined With Unrelated and Related Cord Blood in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders

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.


Inclusion Criteria:

- < 55 years of age

- Life expectancy greater than 3 months

- Lansky performance status ≥ 50% (children) or Karnofsky performance status ≥ 70%
(adults) or ECOG performance status 0-2 (adults)

- DLCO > 50 percent predicted

- Left ventricular ejection fraction > 40% estimated

- Creatinine clearance or estimated GFR . 60 mL/min/1.73m2

- Serum bilirubin < 1.5x upper limit of normal

- Transaminases < 3x upper limit of normal

- Absence of uncontrolled infection

- HIV negative

Exclusion Criteria:

- Fanconi Anemia

- Myocardial infarction within 6 months prior to enrollment or has New York Heart
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe
uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
ischemia or active conduction system abnormalities

- Uncontrolled infection

- Pregnant or breast-feeding females

- Received other investigational agents within 30 days prior to the start of the
conditioning regimen
We found this trial at
3
sites
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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Valhalla, NY
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Denver, Colorado 80045
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Denver, CO
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