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

Kyushu University Hospital0 sites12 target enrollmentApril 20, 2006

ConditionsCritical limb ischemia (CLI) due to arteriosclerosis obliterans or thromboangitis obliterans (Buerger&#39 s disease)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Critical limb ischemia (CLI) due to arteriosclerosis obliterans or thromboangitis obliterans (Buerger&#39
Sponsor: Kyushu University Hospital
Enrollment: 12
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

April 20, 2006

End Date

March 1, 2009

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Kyushu University Hospital

Eligibility Criteria

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