safety study on co -transplantation o f adipose -derived mesenchymal stromal cell and cord blood cells

clinical study to evaluate the safety o f intra-bone marrow cotransplantation o f adipose -derived mesenchymal stromal cells and cord blood cells - iCTAC

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038810

Enrollment

Registered

2019-12-06

Start date

2019-11-27

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 disorders to be applied to cord blood cell transplantation

Interventions

intra bone marrow of adipose-derived mesenchymal stromal cells and cord blood cells

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with hematological disorders to be applied to cord blood cell transplantation. 2. Patient aged from 20 to 70 years 3. The disease is under complete remission (except for MDS). 4. Patients undergoing cord blood trans plantation. 5. Patients with agreements with the documents of this study. 6. Performance status is below 2. 7. Cord blood is available from cord blood center. 8. Patient with favorable organ functions . ejection fraction > 40% % F EV1.0 > =60 and % VC >= 50 AST / ALT < 5 X ULN serum creatinine < 3 X ULN

Exclusion criteria

Exclusion criteria: 1. Patients with HIV infection. 2. Patients with treatment o f Gemtuzumab ozogamicin (within 6 mo nth). 3. Patients with pregnancy, breast feeding or possibility o f pregnancy. 4. Patients with uncontrollable mental illness . 5. Patients with treatment-resistant infection. 6. Patients with drug allergy to wards anti-cancer drug s or immunosuppressants . 7. Patients who had another transplantation within 12 months . 8. Other conditions considered not suitable for the study by doctors .

Design outcomes

Primary

Measure	Time frame
Adverse events related to bone marrow injection of mesenchymal stromal cells within 14 days after transplantation, other adverse events, death and project withdrawal related to adverse event.	—

Secondary

Measure	Time frame
1. engraftment rate , time for recovery of blood cell counts 2. adverse events up to 28 days after transplantation. 3. incidence and severity o f acute GVHD. 4. incidence and severity o f chronic GVHD. 5. treatment-related mortality at day 100 and 1year after transplantation 6. recurrence rate o f the disease at 1 year after transplantation 7. survival rate and disease free survival up to 1 year after trans plantation. 8. incidence of infection	—

Measure

Time frame

1. engraftment rate , time for recovery of blood cell counts 2. adverse events up to 28 days after transplantation. 3. incidence and severity o f acute GVHD. 4. incidence and severity o f chronic GVHD. 5. treatment-related mortality at day 100 and 1year after transplantation 6. recurrence rate o f the disease at 1 year after transplantation 7. survival rate and disease free survival up to 1 year after trans plantation. 8. incidence of infection

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Countries

Japan

Contacts

Public ContactHidefumi Kato

Aichi Medical University Hospital Department of Blood Transfusion and Cell Therapy

hkato@aichi-med-u.ac.jp0561-62-3311

Outcome results

None listed

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