Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study

Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study - Intra-bone marrow injection of cord blood following reduced-intensity conditioning: A phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006529

Enrollment

Registered

2011-10-12

Start date

2011-11-01

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

Interventions

Intra-bone marrow injection of unwashed cord blood following reduced-intensity conditioning

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written informed consent. 2)Unavailability of HLA (A, B, DR)-matched or -one antigen mismatched-related donor. 3)Unavailability of HLA (A, B, DR)-matched or one allele of HLA-DRB1 mismatched-unrelated donor or needs urgent transplantation. 2) Patients aged between 35 and 55 years. 4)Patients aged between 55 and 70 years. Patients aged between 18 and 55 years who are not eligible for myeloablative conditioning. 5) Sufficient organ function 5-1) Ejection Fraction >= 50% 5-2) serum total billirubin is needed to be less than 2.5 times the normal upper limit 5-3) serum creatinine level <= 1.5upper limit of institution

Exclusion criteria

Exclusion criteria: 1) Allergy for the agents used in conditioning or GVHD prophylaxis 2) Patients who are considered as inappropriate with other reasons

Design outcomes

Primary

Measure	Time frame
Rate of donor cell engraftment (>90% of donor origin)	—

Secondary

Measure	Time frame
Incidence of severe GVHD Incidence and severity of chronic GVHD 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 ContactMasaya Okada

hyogo college of medicine Division of Hematology, Department of Internal Medicine

masaya@hyo-med.ac.jp0798-45-6886

Outcome results

None listed

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