Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
Public ClinicalTrials.gov record NCT01064440. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 (Engensis) in Subject With Critical Limb Ischemia
Study identification
- NCT ID
- NCT01064440
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Helixmith Co., Ltd.
- Industry
- Enrollment
- 52 participants
Conditions and interventions
Conditions
Interventions
- High Dose VM202 Biological
- Low Dose VM202 Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 8, 2010
- Primary completion
- Aug 4, 2013
- Completion
- Nov 16, 2023
- Last update posted
- Oct 5, 2025
2010 – 2023
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology PC | Birmingham | Alabama | 35211 | — |
| Vascular and Interventional Specialist of Orange County | Orange | California | 92868 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| St. Vincent Medical Group | Indianapolis | Indiana | 46290 | — |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | — |
| University of Minnesota | Minneapolis | Minnesota | 55454 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| UNC School of Medicine | Chapel Hill | North Carolina | 27599 | — |
| Jobst Vascular | Toledo | Ohio | 43506 | — |
| University of Oklahoma HSC | Oklahoma City | Oklahoma | 73104 | — |
| Texas Heart Institute | Houston | Texas | 77030 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01064440, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2025 · Synced May 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01064440 live on ClinicalTrials.gov.