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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
April 25, 2012
April 26, 2012
October 5, 2016
April 2013
December 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01586455 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Human Placental-Derived Stem Cell Transplantation
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Infusions of thawed HPDSC to be given following UCB infusion.
Other Name: HPDSC
  • Experimental: Group A
    related cord blood with ≥3/6 HLA match to the patient and related HPDSC
    Intervention: Drug: Human Placental Derived Stem Cell
  • Experimental: Group B
    unrelated cord blood with ≥ 4/6 HLA match to the patient and unrelated HPDSC
    Intervention: Drug: Human Placental Derived Stem Cell
  • Experimental: Group C
    unrelated cord blood with ≥4/6 HLA match to the patient but related to HPDSC
    Intervention: Drug: Human Placental Derived Stem Cell
  • Experimental: Group D
    double unrelated cord blood units with ≥4/6 HLA match to patient and each other and unrelated HPDSC
    Intervention: Drug: Human Placental Derived Stem Cell
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 55 Years   (Child, Adult)
No
Contact: Mitchell S Cairo, MD 914-594-2150 mitchell_cairo@nymc.edu
Contact: Lauren Harrison, MSN 617-285-7844 lauren_harrison@nymc.edu
United States
 
 
NCT01586455
NYMC 550
NYMC IRB L-10,733 ( Other Identifier: New York Medical College )
Yes
Not Provided
Not Provided
New York Medical College
New York Medical College
Not Provided
Principal Investigator: Mitchell S Cairo, MD New York Medical College
New York Medical College
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP