Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells

Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells - Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024291

Enrollment

Registered

2016-12-01

Start date

2017-02-25

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

Hematological disorder

Interventions

Intra-bone marrow injection of MSCs generated from bone marrow of third-party donor 4 hours before cord blood transplantation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hematological disorder eligible for cord blood transplantation 2. Age: 20 years or older 3. Malignant cells in bone marrow: less than 70% 4. Patient's agreement to participate in this study 5. Performance status (ECOG): 0 to 2 6. Cord blood unit: HLA-A, B, DR serotypes 4/6 match, total nuclear cell count at 1.5 x 10e7/kg or higher, prioritize cord blood unit containing more CD34 positive cells 7. Ejection fraction: 40% or higher, %FEV1.0: 60% or higher, %VC: 50% or higher, AST/ALT: less than 5 x ULN, serum creatinine: less than 3 x ULN 8. MSC donor: spouse or relative within the fourth degree of relationship

Exclusion criteria

Exclusion criteria: 1. Positive for HIV-Ab 2. Administration of gemtuzumab ozogamicin within 6 months 3. In pregnancy or breast-feeding 4. Uncontrolled psychiatric disorder 5. Uncontrolled infectious disease 6. Allergy to drugs for transplant preconditioning or GVHD prophylaxis 7. Re-transplantation within 1 year from the preceding transplantation 8. Doctor's decision

Design outcomes

Primary

Measure	Time frame
Infusional toxicity of MSCs within 14 days after transplantation	—

Countries

Japan

Contacts

Public ContactMakoto Murata

Nagoya University Graduate School of Medicine Department of Hematology and Oncology

mmurata@med.nagoya-u.ac.jp052-744-2145

Outcome results

None listed

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