Gene therapy shots aim to save legs from amputation

NCT ID NCT01064440

Completed Disease control Sponsor: Helixmith Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a gene therapy called VM202 (Engensis) in 52 people with critical limb ischemia, a severe form of leg artery disease that causes pain and can lead to amputation. Participants received either low-dose, high-dose, or placebo injections into their calf muscles. The goal was to see if the treatment is safe and can reduce pain and improve blood flow. Results will help decide if larger studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: VM202 (Engensis), a DNA plasmid given as injections into the calf muscle
What this could lead to: If successful, VM202 could offer a new way to reduce pain and improve blood flow in people with severe leg artery disease, potentially saving limbs from amputation.
What could go wrong: This is an early Phase 2 trial with only 52 participants, so results may not apply to everyone. The treatment involves multiple injections and may cause side effects; it is not yet proven to work better than placebo.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CRITICAL LIMB ISCHEMIA

Contacts and locations

Locations

Boston University School of Medicine

Boston, Massachusetts, 02118, United States
Cardiology PC

Birmingham, Alabama, 35211, United States
Ewha Womans University Medical Center

Seoul, YangCheon-ku, 158-710, South Korea
Jobst Vascular

Toledo, Ohio, 43506, United States
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Saint Louis University

St Louis, Missouri, 63110, United States
Seoul National University

Seoul, Jongno-gu, 110-744, South Korea
St. Vincent Medical Group

Indianapolis, Indiana, 46290, United States
Texas Heart Institute

Houston, Texas, 77030, United States
The Methodist Hospital

Houston, Texas, 77030, United States
UNC School of Medicine

Chapel Hill, North Carolina, 27599, United States
University of Minnesota

Minneapolis, Minnesota, 55454, United States
University of Oklahoma HSC

Oklahoma City, Oklahoma, 73104, United States
University of Utah

Salt Lake City, Utah, 84132, United States
Vascular and Interventional Specialist of Orange County

Orange, California, 92868, United States
Yonsei University Health System. Severance Cardiovascular Hospital

Seoul, Seodaemun-gu, 120-752, South Korea

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