Enhancement of Hematopoietic Stem Cell Engraftment by Multi Donor Stem Cell Transplantation (MDT) From 2 Mismatched Donors, a Phase I-II Open Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Graft-Versus-Host Disease
- Sponsor
- Hadassah Medical Organization
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Day of neutrophil engraftment
- Last Updated
- 10 years ago
Overview
Brief Summary
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).
Investigators
SHAPIRA MICHAEL
Prof Shapira
Hadassah Medical Organization
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Day of neutrophil engraftment
Time Frame: 30d
Day of platelet engraftment>20x10(9)L
Time Frame: 30
Acute GVHD occurrence>2
Time Frame: 100d
Disease free survival
Time Frame: 100d
Secondary Outcomes
- Transplant related toxicity(100d)
- Immune reconstitution(100d)
- Day of platelet engraftment>50x10(9)/L(30d)
- Time of acute GVHD(100d)
- GVHD grade(100d)
- Overall survival(100 days)
- Infections incidence(100d)
- transplant-related mortality(100d)