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Gene Therapy for the Treatment of Chronic Stable Angina

WithdrawnPhase 1, Phase 2NCT01002495
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to evaluate the safety and tolerability of catheter based injections of VM202 into the heart.

Study details

Official title
A Phase I/II Open Label, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Subjects With Chronic Refractory Myocardial Ischemia
Interventions
  • Biological: VM202
Sponsor
Helixmith Co., Ltd.
Start date
2015-03
Primary completion
2015-07
Sex
All
Age range
from 21 Years to 75 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age ≥ 21 years, but less than or equal to 75 years. * Stable chronic refractory angina classified as Canadian Cardiovascular Society (CCS) functional class II - IV * Left ventricular ejection fraction (LVEF) of ≥30% and ≤ 50%; * Clinical signs and symptoms of significant ischemia by treadmill test or Stress imaging (SPECT, Echo or CARDIAC MRI acceptable) * Subjects must be able to complete a minimum of 3 minutes, but no more than 10 minutes on a Modified Bruce treadmill protocol. * Patients on maximal medical therapy including at least 2 of the following (unless hemodynamic parameters or intolerance contraindicate their use):(a) Long acting nitrate, (b) Beta Blocker or (c) Calcium Channel Blocker (d) Ranolazine. Optimal medical regimen for each subject will be decided by the referring cardiologist or principal investigator. Patients must be on stable medical regimen for 30 days prior to enrollment. * Coronary angiogram within 1 year to confirm the presence of coronary disease which is not amenable to standard revascularization procedures. * Candidates must not be eligible for any other revascularization procedures. The participant and his/her coronary film must have been discussed with an independent cardiac surgeon and must have been denied for CABG or PTCA. Participants who are marginal or poor candidates for conventional revascularization will be considered eligible if the risks of performing a CABG or PTCA procedure outweigh the potential benefit and/or such a procedure is unlikely to offer a worthwhile clinical benefit. The criteria defining such cases may include, but may not be limited to, the following examples: * Diffuse or distal vessel disease * Chronic occlusions * Unprotected left main stenosis * Tortuous or severely angulated vessels * Severely calcified vessels * Small vessels (\< 2.5mm) * Subjects with childbearing potential must take acceptable measure to prevent pregnancy during the course of the study. * Subject capable of understanding with the protocol and signing the informed consent document prior to any study related procedure. Exclusion Criteria: * Subjects who have undergone a successful revascularization procedure within 6 months of enrollment; * MI, unstable angina requiring \> 24 hour hospitalization, or percutaneous coronary intervention, within last 90 days; * Stroke or TIA within last 180 days; * Predominant CHF symptoms; * Hemodynamically significant severe primary valvular heart disease, unless correc…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01002495