Arteriosclerosis obliterance Buerger's disease
Conditions
Interventions
Intra-arterial injection of acidic gelatin hydrogel microsphres (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 or Buerger's disease 2. Fontaine III or Fontaine IV 3. Patients with no improvement by vascular reconstruction therapy and/or drug therapy 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 Ankle pressure index 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