Clinical Trial: Human Placental-Derived Stem Cell Transplantation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Disease

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.

Detailed Summary:
Sponsor: New York Medical College

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: New York Medical College

Dates:
Date Received: April 25, 2012
Date Started: April 2013
Date Completion: December 2019
Last Updated: October 4, 2016
Last Verified: July 2016