Phase I and IIa, Dose Escalation, Non-Randomized, Safety and Efficacy Evaluation Clinical Study for Angiogenic Gene Therapy to Treat Patients with Critical Limb Ischemia via Intramuscular Injection of Non-Transmissible Recombinant Sendai Virus Expressing Human Fibroblast Growth Factor-2 (FGF-2) Gene.

Phase I and IIa, Dose Escalation, Non-Randomized, Safety and Efficacy Evaluation Clinical Study for Angiogenic Gene Therapy to Treat Patients with Critical Limb Ischemia via Intramuscular Injection of Non-Transmissible Recombinant Sendai Virus Expressing Human Fibroblast Growth Factor-2 (FGF-2) Gene. - Phase I and IIa clinical study to treat clitical limb ischemia using SeV/dF-hFGF2

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000404

Enrollment

Registered

2006-04-20

Start date

2006-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical limb ischemia (CLI) due to arteriosclerosis obliterans or thromboangitis obliterans (Buerger&#39

Interventions

DVC-0101: 5x10e7 ciu/60 kg DVC-0101: 2x10e8 ciu/60 kg DVC-0101: 1x10e9 ciu/60 kg DVC-0101: 5x10e9 ciu/60 kg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects will have one or more clinical indications diagnostic of CLI due to arteriosclerosis obliterans or thromboangitis obliterans such as: 1) distal extremity pain at rest that requires the subject to use analgesics for >2 weeks (Fontaine grade III); or peripheral ischemic ulcer(s); or areas of gangrene (Fontaine grade IV, exclude Rutherford grade III, group 6). 1. The subject is a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, unfavorable anatomy, or poor operative risk. 2. Subjects will be without any effect of anti-platelet and/or vasodilator agents for at least 2 weeks prior to treatment. 3. 40 Years and above.

Exclusion criteria

Exclusion criteria: 1. Subjected with severe allergy or its history. 2. Suspected malignant neoplasm (clinical, laboratory or imaging). 3. Subjects who have proliferative diabetic retinopathy or severe, non-proliferative retinopathy. 4. Subjects receiving chronic hemodialysis therapy. 5. Subjects who have severe heart dysfunction or faiure. 6. Subject who have hepatic dysfunction or cirrhosis. 7. Subjects with end stage renal disease (ESRD). 8. Subject who have active inflammatory diseases. 9. Subject who have recieved operative resection of malignant neoplasm 5 years prior to treatment. 10. Subjects who have experienced celebral hemorrhage or infarction 6 months prior to treatment. 11. Subjects with hematopoietic disorders. 12. Alcoholism and/or drug dependence. 13. Female subjects with pregnant or doubt of pregnacy. 14. Othors

Design outcomes

Primary

Measure	Time frame
1. Physical examination 2. Blood and urine analyses 3. ECG 4. Vital signs 5. Adverse events 6. Viral shedding	—

Secondary

Measure	Time frame
1. Improvement of wound healing 2. Reduction of amputation 3. Improvement of rest pain 4. Improvement of hemodynamic measurement	—

Countries

Japan

Contacts

Public ContactToshihiro Onohara/ Takuya Matsumoto

Kyushu University Graduate School of Medical Sciences Department of Surgery and Science

takum@surg2.med.kyushu-u.ac.jp092-642-5466

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026