Unique ID issued by UMIN | UMIN000001606 |
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Receipt number | R000001927 |
Scientific Title | Clinical trial of the new treatment for osteonecrosis of lunate bone using autologous bone marrow stromal cells |
Date of disclosure of the study information | 2008/12/27 |
Last modified on | 2020/01/06 08:58:50 |
Clinical trial of the new treatment for osteonecrosis of lunate bone using autologous bone marrow stromal cells
Clinical trial for osteonecrosis using autologous bone marrow stromal cells
Clinical trial of the new treatment for osteonecrosis of lunate bone using autologous bone marrow stromal cells
Clinical trial for osteonecrosis using autologous bone marrow stromal cells
Japan |
Osteonecrosis of the Lunate bone
Orthopedics |
Others
NO
To analyze the safety and efficacy of mesenchymal stem cell transplantation for osteonecrosis of lunate bone
Safety,Efficacy
Exploratory
Explanatory
Phase I,II
X-ray evaluation of clinical stage on the point of preoperation and two years after operation
Clinical score and bone volume on the point of preoperation, one year after operaion and two years after operation
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Period: 2 years
Volume:10000000 of mesenchymal stem cell
Number:1
Case number intervention: 10 cases
20 | years-old | <= |
60 | years-old | > |
Male and Female
Clinical stage of Xray evaluation (Lichtman classification;Stage 3A and Stage 3B)
Previous medical history against candidate bone
Heavy smorker (Brinkman index>600)
Warfarin treatment
Diabetes mellitus (HbA1c>9.0%)
Arteriosclerosis obliterans
Pregnancy,during lactation
Malignant neoplasm
Cardiac infarction, brain infaction
Rheumatoid arthritis
Dialytic therapy
Complication of blood disease
Live less than 12 months
Active infection
Hypotension(systolic blood pressure<90mmHg)
Low body weight(under 40kg)
Bone marrow dysfunction (neutrophil<1500/mm3, Hb<11.0g/dL(male),Hb<10.0g/dL(women), Plt<100000/mm3)
Patient with the anti-osteoporosis drug and steroid were changed within 3 months
Patient which was judged as inadequate
10
1st name | Junya |
Middle name | |
Last name | Toguchida |
Institute for Frontier Medical Sciences, Kyoto University
Department of Tissue Regeneration
606-8507
53 Kawahara-cho Shogoin Sakyo-ku Kyoto City
075-751-4134
togjun@frontier.kyoto-u.ac.jp
1st name | Izumi |
Middle name | |
Last name | Hashimoto |
Kyoto University Hospital
Department of Orthopaedic Surgery
606-8501
54 Kawahara-cho Shogoin Sakyo-ku Kyoto city
075-751-4400
http://www.kuhp.kyoto-u.ac.jp/~seikeigeka/
seikei@kuhp.kyoto-u.ac.jp
Department of Orthopedic Surgery, Kyoto University Hospital
Kyoto University Hospital
Self funding
Japan
Center for Cell and Molecular Therapy, Kyoto University
Ministry of Health, Labor, and Welfare Ministry of Education, Culture, Sports, Science, and Technology
New Energy and Industrial Technology Development Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
NO
2008 | Year | 12 | Month | 27 | Day |
no protocol
Published
https://www.ncbi.nlm.nih.gov/pubmed/28274511
5
Progression of radiographic stage (Lichtman
classification)was not recognized in all cases.
Average Stahl's index was decreased.
Average bone volume was decreased.
2020 | Year | 01 | Month | 06 | Day |
2017 | Year | 05 | Month | 06 | Day |
stage 3A and 3B
Recruited from outpatient
No Adverse Event
modified Mayo Wrist Score
Stahl's index
Completed
2007 | Year | 08 | Month | 01 | Day |
2007 | Year | 08 | Month | 01 | Day |
2007 | Year | 08 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2014 | Year | 06 | Month | 01 | Day |
2008 | Year | 12 | Month | 27 | Day |
2020 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001927
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