HPDSC: Human Placental-Derived Stem Cell Transplantation
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group A related cord blood with ≥3/6 HLA match to the patient and related HPDSC |
Drug: Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Other Names:
|
Experimental: Group B unrelated cord blood with ≥ 4/6 HLA match to the patient and unrelated HPDSC |
Drug: Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Other Names:
|
Experimental: Group C unrelated cord blood with ≥4/6 HLA match to the patient but related to HPDSC |
Drug: Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Other Names:
|
Experimental: Group D double unrelated cord blood units with ≥4/6 HLA match to patient and each other and unrelated HPDSC |
Drug: Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety [100 days]
to evaluate the safety of human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells in patients with malignant and non-malignant diseases.
Secondary Outcome Measures
- donor chimerism [1 year]
donor chimerism will be assessed at set timepoints
- engraftment [1 year]
- Survival [100 days and 180 days]
- Relapse [100 days and 180 days]
- Mortality [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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< 55 years of age
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Life expectancy greater than 3 months
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Lansky performance status ≥ 50% (children) or Karnofsky performance status ≥ 70% (adults) or ECOG performance status 0-2 (adults)
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DLCO > 50 percent predicted
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Left ventricular ejection fraction > 40% estimated
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Creatinine clearance or estimated GFR . 60 mL/min/1.73m2
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Serum bilirubin < 1.5x upper limit of normal
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Transaminases < 3x upper limit of normal
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Absence of uncontrolled infection
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HIV negative
Exclusion Criteria:
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Fanconi Anemia
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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
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Uncontrolled infection
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Pregnant or breast-feeding females
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Received other investigational agents within 30 days prior to the start of the conditioning regimen
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Children's Hospital Colorado | Denver | Colorado | United States | |
2 | New York Medical College | Valhalla | New York | United States | 10595 |
3 | University of Utah | Salt Lake City | Utah | United States |
Sponsors and Collaborators
- New York Medical College
Investigators
- Principal Investigator: Mitchell S Cairo, MD, New York Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NYMC 550
- NYMC IRB L-10,733