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 |
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.
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
New York Medical College The College was founded in 1860 by a group of New...
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University of Utah Research is a major component in the life of the U benefiting...
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