Unique ID issued by UMIN | UMIN000000845 |
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Receipt number | R000001006 |
Scientific Title | Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute Graft-vs-Host disease after hemopoietic stem cell transplantation |
Date of disclosure of the study information | 2007/10/07 |
Last modified on | 2008/12/09 10:03:28 |
Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute Graft-vs-Host disease after hemopoietic stem cell transplantation
Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute GVHD
Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute Graft-vs-Host disease after hemopoietic stem cell transplantation
Intra-arterial injection of donor mesenchymal stromal cells for treating refractory acute GVHD
Japan |
refractory acute GVHD
Hematology and clinical oncology |
Others
NO
Evaluate safety and efficacy of intra-arterial injection therapy of donor-derived mesenchymal stromal cells for refractory acute GVHD
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Clinical response at 2 weeks after MSC therapy
Clinical response at 4 weeks after MSC therapy
Overall survival at 4 weeks after MSC therapy
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Prevention
Medicine |
Intra-arterial administration of donor-derived mesenchymal stromal cells
15 | years-old | <= |
Not applicable |
Male and Female
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"
1.Positive for HIV Ab
2.Uncontrollable infection such as mucor, EBV-LPD, Gancyclovir-refractory CMV, measles.
3.severe psychiatric disorder
8
1st name | |
Middle name | |
Last name | Nobuyoshi Arima |
The Tazuke Kofukai Medical Research Institute Kitano Hospital
Department of Hematology
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
1st name | |
Middle name | |
Last name | Nobuyoshi Arima |
The Tazuke Kofukai Medical Research Institute Kitano Hospital
Department of Hematology
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
n-arima@kitano-ho.or.jp
Department of Hematology, The Tazuke Kofukai Medical Research Institute Kitano Hospital
CHUGAI PHARMACEUTICAL
Profit organization
National Institute of Advanced Industrial Science and Technology, Research Institute for Cell Engineering
Kirin Pharma Company, Limited
NO
2007 | Year | 10 | Month | 07 | Day |
Partially published
Enrolled case:3
Bone marrow collection & MSC culture:3
Culture using with FCS:0
MSC administration:3(intra-arterial)
Early side effects:0
CR:0
PR:1
NC:1
PD:1
Terminated
2006 | Year | 01 | Month | 27 | Day |
2006 | Year | 04 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 11 | Month | 01 | Day |
Idiopathic pneumonia syndrome developed in two of three cases(Day19,Day160)
2007 | Year | 10 | Month | 07 | Day |
2008 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001006
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