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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00716690 |
The proposed research focuses on the development of innovative protocol of mismatched stem cell transplantation with combined 2 different haplo stem cell transplantation (SCT) donors which are mismatched to the recipient (and preferably to each other), in a patient in need for SCT, lacking an HLA match related or an unrelated donor. This innovative protocol named multi donor stem cell transplantation (MDT) is designed to facilitate engraftment even when reduced intensity conditioning or a low cell dose are used, improve the graft vs. leukemia (GVL) effect and enhance immune reconstitution (using quantitative and qualitative parameters).
Condition | Intervention | Phase |
---|---|---|
Graft-Versus-Host Disease |
Procedure: Multi donor stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Enhancement of Hematopoietic Stem Cell Engraftment by Multi Donor Stem Cell Transplantation (MDT) From 2 Mismatched Donors, a Phase I-II Open Study |
Estimated Enrollment: | 10 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: Michael Y Shapira, MD | 00 972 2 6778351 | shapiram@hadassah.org.il |
Israel | |
Hadassah Medical Organization | Recruiting |
Jerusalem, Israel | |
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il | |
Principal Investigator: Shapira Y Michael, MD |
Principal Investigator: | Michael Y Shapira, MD | Hadassah Medical Organization, Jerusalem, Israel |
Responsible Party: | Hadassah Medical Organization ( Dr. Michael Shapira ) |
Study ID Numbers: | MYS-04-HMO-CTIL |
Study First Received: | July 15, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00716690 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Stem cell transplantation GVHD |
Graft Versus Host Disease Graft vs Host Disease Homologous Wasting Disease |
Immune System Diseases Graft vs Host Disease |