An Open Label,Double Arm,Single Center Pilot Study to Evaluate the Safety and Efficacy of Transplantation of Either StemEx, Umbilical Cord Blood Stem and Progenitor Cells Expanded ex Vivo, or an Unmanipulated Cord Blood Unit in the Elderly Population With Hematologic Malignancies Using Reduced Intensity Regimen
Allogeneic stem cell transplantation is a life saving procedure in selected high-risk or
recurrent hematologic malignancies and marrow failure syndromes. However its wide
application is limited by availability of suitably HLA matched adult donors. Umbilical Cord
Blood (UCB) has been increasingly used as an alternative hematopoietic stem cell source for
these patients. To date, over 10,000 UCB transplants have been performed in both
children32-38 and adults.35,39-44 Its advantages include easier procurement, decreased risk
to donors, reduced risk of transmitting infections, the immediate availability of
cryopreserved units, and acceptable HLA mismatches. The transplantation of UCB allows a
greater degree of HLA mismatching without an unacceptably high incidence of graft versus
host disease (GVHD). Adult patients receiving myeloablative cord blood transplants have a
90% chance of engraftment, but carry a 50% rate of transplant related mortality.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of StemEx
The primary endpoint is to demonstrate the efficacy of Stemex® vs. unmanipulated UCB transplantation in the elderly population (>55years of age) following RIC regimen by demonstrating engraftment with full donor chimerism (>98%) by Day 100 of more than 60% of the patients who received transplants expanded by the Stemex method.
100 days
No
Patrick Stiff, MD
Principal Investigator
Loyola Universtiy Medical Center
United States: Food and Drug Administration
202041
NCT01484470
January 2010
January 2015
Name | Location |
---|---|
Loyola University Medical Center | Maywood, Illinois 60153 |