Multi Donor Mismatched Stem Cell Transplantation (MDT)

Phase 1

• Conditions: Graft-Versus-Host Disease

• Registration Number: NCT00716690
• Lead Sponsor: Hadassah Medical Organization

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-15
• Study First Posted: 2008-07-16
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19
• Primary Completion: 2020-01
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Day of platelet engraftment>20x10(9)L	30
Acute GVHD occurrence>2	100d
Disease free survival	100d
Day of neutrophil engraftment	30d

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel