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Myocardial IschemiaPhase 1/2NCT01002495

Gene Therapy for the Treatment of Chronic Stable Angina

A Phase 1/2 study testing VM202 in people with Myocardial Ischemia, run by Helixmith Co., Ltd. at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Myocardial Ischemia
What is being tested?
VM202
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Mar 2015to Jan 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Northwestern Memorial Hospital

    Chicago, Illinois

  • Minneapolis Heart Institute Foundation/ Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

Other trials in United States

About this study

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

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

Read the 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.

Being tested
VM202
Keywords
myocardial, ischemia, coronary disease, angina
Medical subject headings
Myocardial Ischemia, Ischemia, Coronary Disease, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VM202Biological

    Endocardial injections on Day 0.

Study groups in NCT01002495
Study groupRoleWhat they receive
Cohort 1ExperimentalEight endocardial injection for a total dose of 1mg VM202
Receives: Biological: VM202
Cohort 2ExperimentalEight endocardial injections for a total dose of 2mg VM202
Receives: Biological: VM202
Cohort 3ExperimentalTwelve endocardial injections for a total dose of 3mg VM202
Receives: Biological: VM202

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary study objective is to evaluate safety and tolerability of a catheter-based, endocardial injection of different doses of VM202.

    Measured: Days 1, 7, 14, 21, 30, 60, and 90, 6 and 12 months

Secondary outcomes (2)

  1. Secondary objectives include the assessment of the angiogenic potential of VM202

    Measured: one month, three months, six months and twelve months

  2. Efficacy measures include exercise treadmill test, SPECT, cardiac MRI and change in use of anti-anginal medications.

    Measured: Days 1, 7, 14, 21, 30, 60, and 90. 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2009 (estimated)
  2. Study startMar 2015 (estimated)
  3. Primary completionJul 2015 (estimated)
  4. Study completionJan 2016 (estimated)

Why it stopped: The study was never initiated at any sites.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01002495
Sponsor's protocol ID
VMCAD-001/B
Status last verified
Aug 2025
First submitted
24 Oct 2009
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VM202 in people with Myocardial Ischemia, run by Helixmith Co., Ltd. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary study objective is to evaluate safety and tolerability of a catheter-based, endocardial injection of different doses of VM202. (time frame: Days 1, 7, 14, 21, 30, 60, and 90, 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01002495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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