Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2013-04-30
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group A
related cord blood with ≥3/6 HLA match to the patient and related HPDSC
Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Group B
unrelated cord blood with ≥ 4/6 HLA match to the patient and unrelated HPDSC
Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Group C
unrelated cord blood with ≥4/6 HLA match to the patient but related to HPDSC
Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Group D
double unrelated cord blood units with ≥4/6 HLA match to patient and each other and unrelated HPDSC
Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Interventions
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Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Years
55 Years
ALL
No
Sponsors
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New York Medical College
OTHER
Responsible Party
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Principal Investigators
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Mitchell S Cairo, MD
Role: PRINCIPAL_INVESTIGATOR
New York Medical College
Locations
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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
Countries
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Other Identifiers
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NYMC IRB L-10,733
Identifier Type: OTHER
Identifier Source: secondary_id
NYMC 550
Identifier Type: -
Identifier Source: org_study_id
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