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 1

• Conditions: s disease); Critical limb ischemia (CLI) due to arteriosclerosis obliterans or thromboangitis obliterans (Buerger&#39

• Registration Number: JPRN-C000000404
• Lead Sponsor: Kyushu University Hospital

Brief Summary

To the best of our knowledge, this is the first clinical trial of the use of a gene transfer vector based on rSeV. The single intramuscular administration of DVC1-0101 to PAD patients was safe and well tolerated, and resulted in significant improvements of limb function. Larger pivotal studies are warranted as a next step.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-20
• Study Completion: 2009-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Improvement of wound healing 2. Reduction of amputation 3. Improvement of rest pain 4. Improvement of hemodynamic measurement