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

clinical study to evaluate the safety of intra-bone marrow co-transplantation of adipose-derived mesenchymal stromal cells and cord blood cells - iCTAC

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTa040190133

Enrollment

Registered

2020-03-31

Start date

2019-12-13

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 applicable to cord blood transplantation

Interventions

adipose-derived mesenchymal stromal cell to be injected into bone marrow cavity

intra bone marrow injection

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 who agreed to receive cord blood transplantation. 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 (see the details described below). 8. Patients with favorable organ functions. ejection fraction >= 40% % FEV1.0 > =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 of Gemtuzumab ozogamicin (within 6 months). 3.Patients with pregnancy, breastfeeding or possibility of pregnancy. 4.Patients with uncontrolable mental illness. 5.Patients with treatment-resistant infection. 6.Patients with drug allergy towards anti-cancer drugs 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 counts 2. adverse events up to 28 days after transplantation. 3. incidence and severity of acute GVHD. 4. incidence and severity of chronic GVHD. 5. treatment-related mortality at day 100 and 1year after tranplantation 6. recurrence rate of the disease at 1 year after tranplantation 7. survival rate and disease free survival up to 1 year after transplantation. 8. incidence of infection	—

Measure

Time frame

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

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Countries

Japan

Contacts

Public ContactKosei Furuyama

Aichi Medical University

furuyama.kousei.214@mail.aichi-med-u.ac.jp+81-561-62-3311

Outcome results

None listed

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