refractory acute GVHD
Conditions
Interventions
Intra-arterial administration of donor-derived mesenchymal stromal cells
Sponsors
Department of Hematology, The Tazuke Kofukai Medical Research Institute Kitano Hospital
National Institute of Advanced Industrial Science and Technology, Research Institute for Cell Engineering
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as steroid-refractory acute GVHD in gut or liver 2. No steroid-pulse therapy or ATG therapy within 2 weeks 3. No biological response modifier such as IL-2, IFN, ubenimex within 2 weeks 4. Getting into remission of malignancy 5. no severe or uncontollable infection 6. Meet the following criteria for organ functions (1)Serum AST/GOT or ALT/GPT less than 30 folds of upper normal limit (2)Serum creatinin clearance more than 20ml/min (3)Ejection fraction of cardiac left ventricle more than 50% by ultrasonography (4)Arterial oxygen pressure more than 60 mmHg (5)Arterial bicarbonate pressure less than 60 mmHg"
Exclusion criteria
Exclusion criteria: 1.Positive for HIV Ab 2.Uncontrollable infection such as mucor, EBV-LPD, Gancyclovir-refractory CMV, measles. 3.severe psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response at 2 weeks after MSC therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response at 4 weeks after MSC therapy Overall survival at 4 weeks after MSC therapy | — |
Countries
Japan
Contacts
Public ContactNobuyoshi Arima
The Tazuke Kofukai Medical Research Institute Kitano Hospital Department of Hematology
Outcome results
None listed