Hematopoietic Stem Cell Transplantation Clinical Trial
Official title:
Mesenchymal Stem Cell Infusion in Haploidentical Hematopoietic Stem Cell Transplantation in Patients With Hematological Malignancies
Mesenchymal stem cells (MSCs) have been used in the treatment and prevention of graft-versus host disease (GVHD). In this study the investigators aim to present the efficacy of mesenchymal stem cells in graft versus host disease prophylaxis and effect of engraftment in haploidentical recipients. Forty patients aged older than 18 who have indications for haploidentical hematopoietic stem cell transplantation will be included to the study. MSCs will be isolated from donor bone marrows and infused to the patient after conditioning regimen on day +6. If the haploidentical transplantation results improve with MSCs treatment it would be possible to ameliorate the problem of HLA-matched donor paucity in Turkey and prefer haploidentical donors.
Mesenchymal stem cells (MSCs) have been utilized in the treatment and prevention of
graft-versus-host disease(GVHD) after allogeneic hematopoietic stem cell transplantation
(alloSCT). However, studies on MSC use in alloSCT from haploidentical donors (haploSCT) have
been limited.
In this study, the investigators aim 1) to evaluate MSCs' efficacy in GVHD prophylaxis and
effect on engraftment of the haploidentical graft, 2) to improve the success rate of haploSCT
by further decreasing GVHD incidence and graft failure rate. With higher haploSCT success
rates, haploidentical donors would be important alternative graft sources in patients without
HLA-matched donors.
Forty patients who present to Ankara University, School of Medicine, Division of Hematology
with hematological malignancies and have indications for haploSCT will be included in the
study after informed consent is obtained. MSCs will be procured and isolated from donor bone
marrows. MSCs will be isolated, cultured, and stored in the good manufacturing practice (GMP)
laboratory in Ankara University Stem Cell Institute. Donor bone marrow will be harvested,
four to six weeks prior to transplantation, for MSC isolation and culture. Patients will
receive either an ablative or non-ablative induction regimen based on their age, diagnosis,
and the disease status at the time of transplantation. Donor bone marrow will be harvested a
second time on the day of transplantation and the procured bone marrow graft will be infused
to the patient the same day. GVHD prophylaxis will include post-transplantation
cyclophosphamide (Cy) on days +3 and +4 (50 mg/kg/day), tacrolimus, and mycophenolate
mofetil. Stored MSCs will be infused to the patient on day +6. The endpoints include graft
failure rate, GVHD incidence, transplant-related mortality, disease-free survival, and
overall survival.
The investigators aim to evaluate the utility of MSCs in improving haploSCT results and to
enhance the reliability and success of haploSCT. Successful transplants from haploidentical
donors would ameliorate the problem of matched donor paucity in countries with a limited
number of hematopoietic stem cell donors, such as Turkey, and would establish haploidentical
donors an alternative donor source for patients without matched donors in Turkey. As
haploidentical donors may be parents or children, rapid and easy access to donors would
decrease wait times for alloSCT. Moreover, national current account deficit may be reduced
through using grafts obtained from haploidentical donors residing in Turkey instead of grafts
from foreign stem cell/umbilical cord banks.
In this project, the investigators seek to develop clinical therapy applications in
concordant with the ambition of "renewal and repair of human cells, tissues, and organs
through cellular therapy and cellular products" that is included in the The Scientific and
Technological Research Council of Turkey 1003 Call for Projects.
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