Arteriosclerosis obliterance
Conditions
Interventions
Intra-arterial injection of acidic gelatin hydrogel microspheres (3mg) incorporating human recombinant fibroblast growth factor-2 (trafermin, 0.1mg)
Sponsors
The University of Tokyo Hospital
The University of Tokyo, Division of Tissue Engineering
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Arteriosclerosis obliterance 2. Fontaine II 3. Main occlusive disease is located in femoral artery or more distal part. 4. Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical findings Symptoms Maximum walking distance and time Ankle pressure index Near-infrared spectroscopy Transcutaneous oximetry Skin perfusion pressure Air plethysmography Angiography | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Serum FGF2 concentration | — |
Countries
Japan
Contacts
Public ContactHiroyuki Koyama
The University of Tokyo Hospital Department of Vascular Regeneration
Outcome results
None listed