T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Subjects are being asked to participate in this study because treatment of their disease
requires them to receive a stem cell transplant. Stem cells or "mother" cells are the source
of normal blood cells and lead to recovery of blood counts after bone marrow transplantation
(BMT). Unfortunately, there is not a perfectly matched stem cell donor (like a sister or
brother) and the subject's disease is considered rapidly progressive and does not permit
enough time to identify another donor (like someone from a registry list that is not their
relative). We have, however, identified a close relative of the subject's whose stem cells
are not a perfect match, but can be used. However, with this type of donor, there is
typically an increased risk of developing graft-versus-host disease (GVHD), a high rate of
transplant failure, and a longer delay in the recovery of the immune system.
GVHD is a serious and sometimes fatal side effect of stem cell transplant. GVHD occurs when
the new donor cells (graft) recognizes that the body tissues of the patient (host) are
different from those of the donor. When this happens, cells in the graft may attack the host
organs, primarily the skin, liver, and intestines. The number of occurrences and harshness of
severe GVHD depends on several factors, including the degree of genetic differences between
the donor and recipient, the intensity of the pre-treatment conditioning regimen, the
quantity of transplanted cells, and the recipient's age. In recipients of mismatched family
member or matched unrelated donor stem cell transplants, there is a greater risk of GVHD so
that 70-90% of recipients of unchanged marrow will develop severe GVHD which could include
symptoms such as marked diarrhea, liver failure, or even death.
In an effort to lower the occurrences and severity of graft-versus-host disease in patients
and to lower the rate of transplant failure, we would like to specially treat the donor's
blood cells to remove cells that are most likely to attack the patient's tissues. This will
occur in combination with intense conditioning treatment that the patient will receive before
the transplant.
Phase:
Phase 2
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine Texas Children's Hospital The Methodist Hospital Research Institute The Methodist Hospital System