Intra-bone marrow-bone marrow transplantation (IBM-BMT) with perfusion method

Intra-bone marrow-bone marrow transplantation (IBM-BMT) with perfusion method - Intra-bone marrow-bone marrow transplantation (IBM-BMT)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004663

Enrollment

Registered

2010-12-03

Start date

2010-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory hematological malignancies (acute leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma)

Interventions

To evaluate feasibility of IBM-BMT with perfusion method

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Written informed consent 2) Availability of HLA-matched or three antigen mismatched-related donor. 3) Performance status :0 or 1(ECOG) 4) Sufficient organ function Serum total billirubin is needed to be less than 2.0mg/dl Serum creatinine level is needed to be less than 2.0mg/dl PaO2>=60mmHg or SaO2>=90%(room air) Normal ECG and Ejection fraction >=50% 5) Patients who are considered as appropriate after examination

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Donor: To evaluate feasibility of perfusion method Recipient: To evaluate feasibility of IBM-BMT with perfusion method	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactShinichiro Mori

Kansai Medical University The Department of Hemato-oncology

morish@hirakata.kmu.ac.jp072-804-2831

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026