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Human Placental-Derived Stem Cell Transplantation (HPDSC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by New York Medical College
Sponsor:
Information provided by (Responsible Party):
New York Medical College
ClinicalTrials.gov Identifier:
NCT01586455
First received: April 25, 2012
Last updated: September 23, 2014
Last verified: September 2014

April 25, 2012
September 23, 2014
April 2013
December 2018   (final data collection date for primary outcome measure)
Safety [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
    donor chimerism will be assessed at set timepoints
  • engraftment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 100 days and 180 days ] [ Designated as safety issue: No ]
  • Relapse [ Time Frame: 100 days and 180 days ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Both
up to 55 Years
No
Contact: Mitchell S Cairo, MD 914-594-3650 mitchell_cairo@nymc.edu
Contact: Lauren Harrison, MSN 978-993-4372 lauren_harrison@nymc.edu
United States
 
NCT01586455
NYMC 550, NYMC IRB L-10,733
Yes
New York Medical College
New York Medical College
Not Provided
Principal Investigator: Mitchell S Cairo, MD New York Medical College
New York Medical College
September 2014

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