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Human Placental-Derived Stem Cell Transplantation (HPDSC)

This study is currently recruiting participants.
Verified July 2016 by New York Medical College
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586455
First Posted: April 26, 2012
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York Medical College
  Purpose
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 Intervention Phase
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 Drug: Human Placental Derived Stem Cell Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by New York Medical College:

Primary Outcome Measures:
  • Safety [ Time Frame: 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 [ Time Frame: 1 year ]
    donor chimerism will be assessed at set timepoints

  • engraftment [ Time Frame: 1 year ]
  • Survival [ Time Frame: 100 days and 180 days ]
  • Relapse [ Time Frame: 100 days and 180 days ]
  • Mortality [ Time Frame: 1 year ]

Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: HPDSC
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 Name: HPDSC
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 Name: HPDSC
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 Name: HPDSC

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01586455


Contacts
Contact: Mitchell S Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu
Contact: Lauren Harrison, MSN 617-285-7844 lauren_harrison@nymc.edu

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Denver, Colorado, United States
Contact: Roger Giller, MD       Roger.Giller@childrenscolorado.org   
United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Mitchell Cairo, MD    914-594-2150    mitchell_cairo@nymc.edu   
Contact: Lauren Harrison, MSN    6172857844    lauren_harrison@nymc.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States
Contact: Michael Pulsipher, MD       michael.pulsipher@hsc.utah.edu   
Sponsors and Collaborators
New York Medical College
Investigators
Principal Investigator: Mitchell S Cairo, MD New York Medical College
  More Information

Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT01586455     History of Changes
Other Study ID Numbers: NYMC 550
NYMC IRB L-10,733 ( Other Identifier: New York Medical College )
First Submitted: April 25, 2012
First Posted: April 26, 2012
Last Update Posted: October 5, 2016
Last Verified: July 2016

Keywords provided by New York Medical College:
umbilical cord blood
stem cell transplantation
placental stem cell
inborn errors of metabolism
marrow failure
Severe Combined Immunodeficiency Disease
AML
ALL
MDS

Additional relevant MeSH terms:
Gaucher Disease
Leukemia
Anemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Thrombocytopenia
Leukemia, Myeloid, Acute
Anemia, Aplastic
Mucopolysaccharidoses
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Adrenoleukodystrophy
Pick Disease of the Brain
Aphasia, Primary Progressive
Frontotemporal Dementia
Anemia, Diamond-Blackfan
Leukodystrophy, Metachromatic
Niemann-Pick Diseases
Niemann-Pick Disease, Type A
Niemann-Pick Disease, Type C
Mucopolysaccharidosis I
Neuronal Ceroid-Lipofuscinoses
Wolman Disease
Leukodystrophy, Globoid Cell
Mucopolysaccharidosis VI
Fucosidosis
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases