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Safety Study of Gene Therapy in Treating Critical Leg Ischemia

NCT00696124 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-06

Study results available
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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.

Conditions

  • Critical Limb Ischemia

Interventions

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.

Sponsors & Collaborators

  • Helixmith Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Timothy Henry, MD · Minneapolis Heart Institute Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-03
Primary Completion
2009-10-19
Completion
2023-12-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00696124 on ClinicalTrials.gov