Phase I study of cord blood transplantation with intra-bone marrow injection of mesenchymal stromal cells
- Conditions
- Hematological disorder
- Registration Number
- JPRN-UMIN000024291
- Lead Sponsor
- Department of Hematology and Oncology, Nagoya University Graduate School of Medicine
- Brief Summary
Five adult patients received MSC-CBT, and no adverse events related to intra-BM injection of MSCs were observed. All patients achieved neutrophil, reticulocyte, and platelet recoveries, with median times to recoveries of 21, 35, and 38 days, respectively. Grade II-IV acute GVHD did not develop in MSC-CBT patients. No patients developed chronic GVHD. At 1 year after transplantation, all MSC-CBT patients survived without relapse.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infusional toxicity of MSCs within 14 days after transplantation
- Secondary Outcome Measures
Name Time Method