NCT00696124

Safety Study of Gene Therapy in Treating Critical Leg Ischemia

Phase 1, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 (Engensis) in Subjects With Critical Limb Ischemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Helixmith Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of intramuscular injections of VM202 for subjects with critical limb ischemia. Subjects selected for this study will have critical limb ischemia that has not responded to standard therapy with symptoms including pain at rest and/or ischemic ulcers.

Detailed description

The study will consist of four (4) cohorts with a total of 3 subjects enrolled in each cohort to VM202.For each dose cohort, VM202 will be administered as a local intramuscular injection in 2 divided doses with a 2-week interval between the injections. Preliminary efficacy (hemodynamic assessments), safety and tolerability will be evaluated at Baseline (screening) and at designated time points throughout the study. After the first subject in each cohort completed Day 30 (±2 days), and before the Day 15 dosing of the other 2 subjects in the same cohort, an interim safety evaluation was performed with the submission of safety data to the Data Safety Monitoring Committee. All four dose cohorts will be followed for up to 5 years from the time of the first dose of study drug administration.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	VM202 2 mg	2 mg intramuscular injection with the first half of the total dose given on Day 1 and the second half on Day 15
BIOLOGICAL	VM202 4 mg	4 mg intramuscular injection, with half of the total dose given on Day 1 and the second half given on Day 15
BIOLOGICAL	VM202 8 mg	8 mg intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.
BIOLOGICAL	VM202 16 mg	16 mg dose intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.

Timeline

• Start date: 2007-04-03
• Primary completion: 2009-10-19
• Completion: 2023-12-11
• First posted: 2008-06-12
• Last updated: 2025-10-06
• Results posted: 2024-10-18

Locations

1 site across 1 country: United States