Myelodysplastic Syndrome Clinical Trial
Human Placental-Derived Stem Cell Transplantation
Summary
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.
Eligibility Criteria
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
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There is 1 Location for this study
Denver Colorado, , United States
Valhalla New York, 10595, United States
Salt Lake City Utah, , United States
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