NCT01484470

Umbilical Cord Transplantation for the Elderly Population

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 55 Years – 73 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	StemEx	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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2018-11-21
• Completion: 2018-11-21
• First posted: 2011-12-02
• Last updated: 2019-08-21

Locations

1 site across 1 country: United States