UMIN ID: UMIN000000825
Registered date:14/09/2007
Treatment of Spinal Cord Injury with Olfactory Mucosa Autgrafts in Human Spinal Cord Injury : Phase 1 and 2 Clinical Study
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | spinal cord injury |
Date of first enrollment | 2006/10/01 |
Target sample size | 15 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Olfactory Mucosa Autografts(+) Fasudil Hydrochloride Hydrate(+) Olfactory Mucosa Autografts(+) Fasudil Hydrochloride Hydrate(-) |
Outcome(s)
Primary Outcome | Safety infection and malignant neoplasm |
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Secondary Outcome | Effeicacy ASIA scoring,SSEP,MEG,MEP urinary function |
Key inclusion & exclusion criteria
Age minimum | 7years-old |
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Age maximum | 40years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1.It bleeds at the spinal cord. 2.Mental disease. 3.Alcohol dependence 4.Consciousness disorder. 5.Malignant tumor/ 6.HIV, HBV, HCV, HTLV, CMV,syphilis. 7.Liver or Renal fault. 8.Respiratory fault. 9.Hypotension. Diabetes. 10.When judged not to suit |
Related Information
Primary Sponsor | Department of Neurosurgery, Osaka University Medical School |
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Secondary Sponsor | |
Source(s) of Monetary Support | center of excellence |
Secondary ID(s) |
Contact
public contact | |
Name | Koichi Iwatsuki |
Address | 2-2 YAMADAOKA SUITA OSAKA, 565-0871 JAPAN Japan |
Telephone | 06-6879-3652 |
kiwatsuki@nsurg.med.osaka-u.ac.jp | |
Affiliation | Osaka University Medical School Department of Neurosurgery |
scientific contact | |
Name | Toshiki Yoshimine |
Address | 2-2 YAMADAOKA SUITA OSAKA, 565-0871 JAPAN Japan |
Telephone | 06-6879-3652 |
Affiliation | Osaka University Medical School Department of Neurosurgery |