Heart gene therapy trial pulled before it even started
NCT ID NCT01002495
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to test the safety of a gene therapy called VM202 in people with chronic refractory myocardial ischemia—severe chest pain that doesn't improve with standard treatments. The therapy would be injected directly into the heart via a catheter. However, the trial was withdrawn before enrolling any participants, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VM202 (gene therapy)
- What this could lead to
- If successful, VM202 could offer a new way to reduce chest pain and improve blood flow in patients with severe, untreatable heart ischemia.
- What could go wrong
- This trial was withdrawn before any patients enrolled, so no data exists. Gene therapies carry risks like inflammation or arrhythmia, and earlier-stage results are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Expected to start
-
Mar 2015
An estimate. Start dates often move.
- Expected to finish
-
Jan 2016
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 corrected by a properly functional prosthetic valve; * Uncontrolled hypertension as defined as systolic BP 170 mmHg or diastolic \> 90 mmHg at baseline/ screening evaluation; * Sustained ventricular tachycardia or automatic implantable cardiodefibrillator (AICD) firing within last 180 days; * History of ventricular fibrillation; * Use of the MyoStar catheter may not be appropriate for patients with prosthetic valves. Patients with a mechanical valve at risk for injury due to the interventional approach should be excluded; * Subjects with any comorbidity that may interfere with the ability to perform a maximal treadmill test (e.g. severe arthritis, musculoskeletal disorders, COPD); * Subjects with a history of malignancy, a known active malignancy, or a new screening finding of malignant neoplasm; * Patients with family history of colon cancer in any first degree relative unless they have undergone a colonoscopy in the last 12 months with negative findings; * Elevated PSA unless prostate cancer has been excluded; * Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination. * Cataract surgery within 6 months of trial; * Vascular lesions of the anterior segment of the eye (infection or ulceration of the cornea, rubeotic glaucoma, etc); * Vascular lesions of the posterior segment of the eye or proliferative retinopathy in diabetics, macular edema, s/p photocoagulation for macular edema or proliferative retinopathy; nondiabetics with central or branch retinal vascular occlusions, sickle cell retinopathy, ischemic retinopathy due to retinal venous stasis or carotid artery disease); * Choroidal new vessels associated with age-related macular degeneration, myopic degeneration, presumed ocular histoplasmosis syndrome, angioid streaks, pseudoxanthoma elasticum, or without ocular disease; and * Large elevated choroidal nevi, choroidal vascular tumors (choroidal hemangioma), or melanomas. * Chronic inflammatory disease (e.g. Crohn, Rheumatoid Arthritis); * Active infectious disease and/or known to have tested positive for human immunodeficiency virus (HIV), human t lymphotrophic virus (HTLV), hepatitis B virus (HBV), or hepatitis C virus (HCV); * Specific laboratory values at Screening including: Hemoglobin \< 9.0, g/dL, WBC \< 3,000 cells per microliter, platelet count \<75,000/mm3, Creatinine \> 2.0 mg/dL, AST and/or ALT \> 3 times the upper limit of normal or any other clinically significant lab abnormality which in the opinion of the investigator should be exclusionary; * Patients have undergone enhanced external pulsation (EECP) treatment within the last 6 months; * Pregnancy or lactation; * Severe comorbidity associated with a reduction of life expectancy of less than 1 year; * Exposure to any previous experimental angiogenic therapy and/or myocardial laser therapy; or therapy with another investigational drug within 180 days of enrollment or participation in any concurrent study that may confound the results of this study; * Major psychiatric disorder in past 6 months; * History of recent tobacco abuse (within past \< 5 years); * Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Minneapolis Heart Institute Foundation/ Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
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Northwestern Memorial Hospital
Chicago, Illinois, United States
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Other studies related to the condition(s) this trial covers.
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