Trial Of Double Umbilical Cord Blood Transplantation
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This pilot research study is to investigate the safety and effectiveness of stem cell
transplantation to treat blood-related (hematopoietic) cancers, using stem cells collected
from two different, umbilical cord blood donors. Subjects in this study are receiving a stem
cell transplant because other treatments have failed or their disease is unlikely to respond
to other treatment options.
Blood-related cancers can be treated and sometimes cured with very high doses of chemotherapy
and radiation therapy, given to kill the cancer cells; however, these treatments can prove
unsuccessful and can harm normal cells in the bone marrow or a patient's disease may be
unlikely to respond to these treatment options.
Hematopoietic stem cells transplantation (HSCT) is a potential cure, but opportunities to
perform HSCT are limited by donor availability. Only 20-30% of patients may have matched
family donors. In some cases, a mismatched family donor may be suitable. For patients needing
a transplant who do not have a suitably matched family donor, blood stem cells from matched
unrelated donors can be used. The length of time required to identify a matched unrelated
donor presents another obstacle for patients waiting to receive an HSCT.
Blood stem cells are found in umbilical cord blood (UCB), which is blood left over in the
placenta (afterbirth) after a baby is born. Usually this blood is discarded with the
placenta, but over the past 15 years, we have learned how to collect and freeze cord blood
cells to be used for transplants at a later time. A cord blood unit is the cord blood cells
collected and stored from a single placenta. More than 6,500 umbilical cord blood stem cell
transplants have been done worldwide, mostly in children with leukemia. One important factor
affecting the success of a cord blood transplant is the cell dose (number of stem cells in
the cord blood unit / recipient's weight). Patients who receive a high cell dose (> 2.5 x 107
cells/kilogram) have better marrow recovery and a higher rate of survival than those who
receive a lower cell dose.
In an attempt to make UCB transplantation possible for bigger children, adolescents and
adults, researchers have tried giving two cord blood units on the same day for their
transplant, one after the other. The data from more than 150 "double cord blood" transplants
in adults suggest that the "double cord blood" transplants may allow bone marrow recovery and
survival in patients who do not have a single cord blood unit with enough cells for
successful transplantation.
This is a pilot study to research the safety and effectiveness of using two UCB units in
adult and pediatric UCB transplantation when combined with a conditioning regimen called
Flu/Bu4/TLI (consisting of fludarabine, busulfan and total lymphoid irradiation).
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.