Human Placental-Derived Stem Cell Transplantation
Completed · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT01586455
- Run by
- New York Medical College
- People needed
- 43
- Starts
- 2013-04-01
- Expected to finish
- 2022-09-01
- Last updated by the study team
- 2022-10-25
Who can join
Age: any, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- < 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.