UMIN ID: C000000200
Registered date:13/09/2005
Therapeutic angiogenesis with acidic gelatin hydrogel microspheres incorporating fibroblast growth factor-2 for critical limb ischemia
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Arteriosclerosis obliterance Buerger's disease |
| Date of first enrollment | 2004/12/01 |
| Target sample size | 10 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Intra-arterial injection of acidic gelatin hydrogel microsphres (3mg)incorporating human recombinant fibroblast growth factor-2 (trafermin, 0.1mg) |
Outcome(s)
| Primary Outcome | Physical findings Symptoms Ankle pressure index Transcutaneous oximetry Skin perfusion pressure Air plethysmography Angiography |
|---|---|
| Secondary Outcome | Adverse events Serum FGF2 concentration |
Key inclusion & exclusion criteria
| Age minimum | 35years-old |
|---|---|
| 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 |
|---|---|
| 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 |