Human Placental-Derived Stem Cell Transplantation
Mucopolysaccharidosis I - Mucopolysaccharidosis VI - Adrenoleukodystrophy - Niemann-Pick Disease - Metachromatic Leukodystrophy - Wolman Disease - Krabbe's Disease - Gaucher's Disease - Fucosidosis - Batten Disease - Severe Aplastic Anemia - Diamond-Blackfan Anemia - Amegakaryocytic Thrombocytopenia - Myelodysplastic Syndrome - Acute Myelogenous Leukemia - Acute Lymphocytic Leukemia
Conditions: official terms
Adrenoleukodystrophy - Anemia - Anemia, Aplastic - Anemia, Diamond-Blackfan - Aphasia, Primary Progressive - Frontotemporal Dementia - Fucosidosis - Gaucher Disease - Leukemia - Leukemia, Lymphoid - Leukemia, Myeloid - Leukemia, Myeloid, Acute - Leukodystrophy, Globoid Cell - Leukodystrophy, Metachromatic - Mucopolysaccharidoses - Mucopolysaccharidosis I - Mucopolysaccharidosis VI - Myelodysplastic Syndromes - Neuronal Ceroid-Lipofuscinoses - Niemann-Pick Disease, Type A - Niemann-Pick Disease, Type C - Niemann-Pick Diseases - Pick Disease of the Brain - Precursor Cell Lymphoblastic Leukemia-Lymphoma - Preleukemia - Thrombocytopenia - Wolman Disease
Conditions: Keywords
umbilical cord blood, stem cell transplantation, placental stem cell, inborn errors of metabolism, marrow failure, Severe Combined Immunodeficiency Disease, AML, ALL, MDS
Study Type
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Human Placental Derived Stem Cell
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 55 Years
Minimum Age: N/A
Gender: Both
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
New York Medical College
Valhalla, New York, United States
Status: Recruiting
Contact: Mitchell Cairo, MD - 914-594-2150 -
University of Utah
Salt Lake City, Utah, United States
Status: Recruiting
Contact: Michael Pulsipher, MD -
Start Date
April 2013
Completion Date
December 2019
New York Medical College
New York Medical College
Record processing date processed this data on July 28, 2015 page