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NCT01586455 Clinical Trial

Human Placental-Derived Stem Cell Transplantation

Myelodysplastic Syndrome Clinical Trial

— HPDSC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01586455
Other study ID # NYMC 550
Secondary ID NYMC IRB L-10,73
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2013
Est. completion date September 2022

Study information
Verified date October 2022
Source New York Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date September 2022
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group 0 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Acute Lymphocytic Leukemia
  • Acute Myelogenous Leukemia
  • Adrenoleukodystrophy
  • Amegakaryocytic Thrombocytopenia
  • Anemia
  • Anemia, Aplastic
  • Anemia, Diamond-Blackfan
  • Batten Disease
  • Diamond-Blackfan Anemia
  • Fucosidosis
  • Gaucher Disease
  • Gaucher's Disease
  • Krabbe's Disease
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukodystrophy, Globoid Cell
  • Leukodystrophy, Metachromatic
  • Metachromatic Leukodystrophy
  • Mucopolysaccharidoses
  • Mucopolysaccharidosis I
  • Mucopolysaccharidosis VI
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Neuronal Ceroid-Lipofuscinoses
  • Niemann-Pick Disease
  • Niemann-Pick Disease, Type C
  • Niemann-Pick Diseases
  • Pick Disease of the Brain
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Severe Aplastic Anemia
  • Thrombocytopenia
  • Wolman Disease

Intervention

Drug:
• Human Placental Derived Stem Cell
Infusions of thawed HPDSC to be given following UCB infusion.

Locations
Country Name City State
United States Children's Hospital Colorado Denver Colorado
United States University of Utah Salt Lake City Utah
United States New York Medical College Valhalla New York

Sponsors (1)
Lead Sponsor Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety 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. 100 days
Secondary donor chimerism donor chimerism will be assessed at set timepoints 1 year
Secondary engraftment 1 year
Secondary Survival 100 days and 180 days
Secondary Relapse 100 days and 180 days
Secondary Mortality 1 year
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