Overview

Randomized Phase IIb Trial of DVC1-0101

Status:
Active, not recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
DVC1-0101 is a gene therapy medicine to treat peripheral arterial disease (PAD) based on recombinant F-gene-deleted, non-transmissible Sendai virus (rSeV/dF) expressing human fibroblast growth factor-2 (FGF-2) gene. The primary objective of the current Phase IIb study is to investigate the clinical efficacy of DVC1-0101 (1x10^9 ciu/leg, 5x10^9 ciu/leg) in patients with IC.
Phase:
Phase 2
Details
Lead Sponsor:
Kyushu University
Collaborators:
CPC Clinical Research (Collorado, USA)
Iberica Co. Ltd. (Fukuoka, Japan)
Japan Agency for Medical Research and Development
Ministry of Health, Labour and Welfare, Japan