UMIN ID: C000000201
Registered date:13/09/2005
Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for intermittent claudication
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Arteriosclerosis obliterance |
Date of first enrollment | 2005/03/01 |
Target sample size | 10 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Intra-arterial injection of acidic gelatin hydrogel microspheres (3mg) incorporating human recombinant fibroblast growth factor-2 (trafermin, 0.1mg) |
Outcome(s)
Primary Outcome | Physical findings Symptoms Maximum walking distance and time Ankle pressure index Near-infrared spectroscopy Transcutaneous oximetry Skin perfusion pressure Air plethysmography Angiography |
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Secondary Outcome | Adverse events Serum FGF2 concentration |
Key inclusion & exclusion criteria
Age minimum | 40years-old |
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Age maximum | 85years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1. Hypersensitivity for gelatin hydrogel 2. Serious medical co-morbidities 3. Alcoholism or other drug dependence within 3 months 4. Malignancy within 5 years 5. Possibility of malignancy 6. Operations within 3 months 7. Severe diabetic retinopathy 8. Pregnant woman, lactating woman 9. Vascular reconstruction within 2 months 10. Other complication unsuitable for the study |
Related Information
Primary Sponsor | The University of Tokyo Hospital |
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Secondary Sponsor | The University of Tokyo, Division of Tissue Engineering |
Source(s) of Monetary Support | The Ministry of Education, Science, Sports and Culture |
Secondary ID(s) |
Contact
public contact | |
Name | Hiroyuki Koyama |
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan Japan |
Telephone | 03-3815-8411 |
hkoyama-tky@umin.ac.jp | |
Affiliation | The University of Tokyo Hospital Department of Vascular Regeneration |
scientific contact | |
Name | Tetsuro Miyata |
Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan Japan |
Telephone | 03-3815-8411 |
Affiliation | The University of Tokyo Hospital Department of Surgery, Division of Vascular Surgery |