Gene Therapy for the Treatment of Chronic Stable Angina

NCT01002495 | Withdrawn Phase 1 DMC

• 1 other identifier: VMCAD-001/B
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Myocardial Ischemia

Keywords

myocardial; ischemia; coronary disease; angina

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (2)

• Secondary objectives include the assessment of the angiogenic potential of VM202

  one month, three months, six months and twelve months

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

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

Study Arms (3)

Cohort 1

EXPERIMENTAL

Eight endocardial injection for a total dose of 1mg VM202

Biological: VM202

Cohort 2

EXPERIMENTAL

Eight endocardial injections for a total dose of 2mg VM202

Biological: VM202

Cohort 3

EXPERIMENTAL

Twelve endocardial injections for a total dose of 3mg VM202

Biological: VM202

Interventions

VM202 BIOLOGICAL

Endocardial injections on Day 0.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Helixmith Co., Ltd.: lead

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Location

Minneapolis Heart Institute Foundation/ Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia; Ischemia; Coronary Disease; Angina Pectoris

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2009
• First Posted: October 27, 2009
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 25, 2025

Record last verified: 2025-08

Locations

US (2)