While cord blood transplants have been performed safely in elderly patients, many still relapse. The investigators propose to intensify the preparative regimen for this patient group in an attempt to decrease relapses, and combine this with an ex vivo expanded Umbilical Cord Blood (UCB) unit.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
For patients allocated to StemEx® arm: * Day -20: Start small (or equal) portion expansion at processing site. (II) Conditioning Phase * Day -6 to -1: Subject receives a RIC regimen containing Fludarabine, Cyclophosphamide and Total Body Irradiation (TBI) (III) Transplantation and Follow-up Phase * Day 0: CBU unmanipulated portion transplantation (for StemEx® arm) or unmanipulated CBU transplantation. * Day 1: StemEx® transplantation. * Day 2 to 3 years: Post transplant follow-up.
Loyola University Medical Center
Maywood, Illinois, United States
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.
Time frame: 100 days
Time to engraftment
The day of neutrophil engraftment is defined as the first day of 3 consecutive days of an ANC greater than 500/microliter. The platelet recovery is the first of 3 consecutive measurements tested on different days of a platelet count greater than or equal to 20,000 without requiring platelet transfusions in the previous 7 days. Patients will be monitored for donor cell engraftment as evidenced by neutrophil recovery and donor chimerism in the marrow and/or peripheral blood at serial time points post transplant.
Time frame: 42 days
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