HPDSC: Human Placental-Derived Stem Cell Transplantation

Sponsor
New York Medical College (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01586455
Collaborator
(none)
43
3
4
104
14.3
0.1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
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
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

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:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • HPDSC
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. donor chimerism [1 year]

      donor chimerism will be assessed at set timepoints

    2. engraftment [1 year]

    3. Survival [100 days and 180 days]

    4. Relapse [100 days and 180 days]

    5. Mortality [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.
    Responsible Party:
    New York Medical College
    ClinicalTrials.gov Identifier:
    NCT01586455
    Other Study ID Numbers:
    • NYMC 550
    • NYMC IRB L-10,733
    First Posted:
    Apr 26, 2012
    Last Update Posted:
    Nov 1, 2021
    Last Verified:
    Oct 1, 2021

    Study Results

    No Results Posted as of Nov 1, 2021