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Gene shot into heart shows promise in early safety trial

NCT ID NCT01422772

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a gene therapy called VM202RY in 9 people with ischemic heart disease who had incomplete revascularization after bypass surgery. The therapy was injected directly into heart muscle areas that still had poor blood flow. The main goal was to check safety over 6 months, and researchers also looked at changes in heart function using MRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VM202RY (Engensis) gene therapy
What this could lead to
If successful, this could lead to a new gene-based treatment to improve blood flow and heart function in people with severe heart disease who cannot be fully treated with bypass surgery alone.
What could go wrong
This is a very early, small trial with only 9 participants, so results may not apply to everyone. The main goal is safety, not effectiveness, and gene therapies can have unexpected side effects.

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.

Participants

9 people

The number who actually took part.

Start date

Jan 2007

Finished

Aug 2014

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

19 to 75 years

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged ≥ 19 and ≤ 75 years 2. Patients in whom decrease of myocardial perfusion in coronary artery territories (rest perfusion - stress perfusion: ≥ 7%) was observed by myocardial SPECT 3. Patients judged to have possibly incomplete revascularization based on the observation of the coronary artery's internal diameter of ≤ 1 mm, diffuse atherosclerosis or severe calcification on coronary angiography, or patients judged to have some myocardial perfusion territories that could not be performed Coronary Artery Bypass Graft 4. Patients who or whose legal representative can write the informed consent before the initiation of the clinical study and comply with the requirements Exclusion Criteria: 1. Patients with progressive or present heart failure 2. Patients with uncontrolled ventricular arrhythmia on electrocardiogram, or who have been treated for ventricular arrhythmia 3. Patients with current or history of malignant tumor 4. Patients with severe infectious disease 5. Patients with uncontrolled hematologic disorders 6. Patients requiring surgery for the accompanying valve diseases or left ventricular volume reduction surgery 7. Patients with current or history of proliferative retinopathy 8. Patients with remaining life of less than 1 year and severe accompanying diseases enough to die during the clinical follow-up period 9. Patients with history of drug or alcohol abuse within the recent 3 months 10. Women who are pregnant or breast feeding or postmenopausal women of childbearing age. However, women who underwent surgical sterilization including hysterectomy or bilateral tubal ligation can participate in this clinical trial. Even though they consent to the contraception, they cannot be enrolled. 11. Patients in inappropriate condition judged by investigators 12. Patients with cerebrovascular diseases (cerebral infarction, cerebral bleeding or transient ischemic attack that are currently occurring or occurred within 6 months) 13. Patients with idiopathic hypertension who are not controlled with drugs 14. Patients with severe hepatic disorders 15. Patients with severe renal disorders 16. Patients who underwent Coronary Artery Bypass Graft 17. Patients who underwent angioplasty within 1 year before their enrollment in the study

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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

  • Seoul National University Hospital

    Seoul, South Korea

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