Trials / Withdrawn
WithdrawnNCT01002495
Gene Therapy for the Treatment of Chronic Stable Angina
A Phase I/II Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Subjects With Chronic Refractory Myocardial Ischemia
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Helixmith Co., Ltd. · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerability of catheter based injections of VM202 into the heart.
Detailed description
A phase I/II, open label, dose-escalation, multicenter, 12 month study designed to assess the safety and tolerability of catheter based percutaneous myocardial injection of VM202 in patients with chronic refractory myocardial ischemia. The study will consist of three (3) cohorts with a total of 4 subjects enrolled in each cohort. Endocardial injections will be performed with the MyoStar Injection Catheter under guidance of the NOGA XP Cardiac Navigation System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VM202 | Endocardial injections on Day 0. |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-07-01
- Completion
- 2016-01-01
- First posted
- 2009-10-27
- Last updated
- 2025-09-25
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01002495. Inclusion in this directory is not an endorsement.