Intra-bone marrow-bone marrow transplantation (IBM-BMT) with perfusion method
Phase 1
Suspended
- Conditions
- Refractory hematological malignancies (acute leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma)
- Registration Number
- JPRN-UMIN000003555
- Lead Sponsor
- Kansai Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
Exclusion Criteria
Positivity of HBs Ag, HIV Ab (not exclusion of HCV Ab positive) Patient with active infection Bone marrow show fibrosis Patients who are considered as inappropriate with other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Donor: To evaluate feasibility of perfusion method Recipient: To evaluate feasibility of IBM-BMT with perfusion method
- Secondary Outcome Measures
Name Time Method Donor :operation time, anesthesia time numbers of puncture site, volume of blood transfusion, number of bone marrow nuclear cell, number of CD3,CD34 positive cells, contamination of red blood cells Recipient: Rate of donor cell engrafment, Incidence and severity of acute and chronic GVHD, Overall survival and disease free survival at 1 year after transplantation, Treatment related mortality within 1 year after transplantation, Incidence of infections (bacteria, fungus, virus,etc) Immune reconstitution after transplantation