Ad-HGF Treatment for Myocardial Infarction

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This will be the first clinical trial use Ad-HGF gene for the treatment of myocardial infarction disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

• Male or female 18-80 years of age

• Clinical diagnosis of anterior ST-segment elevation myocardial infarction (STEMI) within the last 30 days, with any one of the following 12-lead electrocardiographic changes:

• a) Greater than or equal to 2 mm ST-segment elevation) in 2 adjacent electrocardiographic precordial leads

• b) A new left bundle branch block AND and an increase in cardiospecific enzymes >3x CK, or increase in troponin compared to institution laboratory normal ranges

• Successful PCI with stent implantation to infarct-related artery within the last 30 days; defined as residual stenosis no greater than 30%, Thrombolysis In Myocardial Infarction (TIMI) flow of at least 2 and a reference diameter of at least > 2mm

• Is considered hemodynamically stable at time of enrollment and immediately prior to Ad-HGF delivery

• Screening LVEF for the first 12 enrolled participants, must be no greater than 40% by echocardiography (determined by Simpson's method) performed at least 2 days after revascularization procedure. Subsequent participants enrolled in the trial, must have an LVEF no greater than 45%. (All screening echos done within the first 4 days post percutaneous coronary intervention (PCI) must be repeated either by echocardiography or MRI prior to Ad-HGF delivery to ensure that the variability does not exceed 10%)

• In the case of a previous myocardial infarction, documented LVEF must be 50% or greater

• Female participants must be surgically sterile, post-menopausal, have documented infertility, or are of child-bearing potential wih laboratory confirmation of non-pregnant state

• Provided written informed consent and is willing to comply with study follow-up visits

Exclusion Criteria:

• Significant unprotected left main disease (stenosis of 50% or greater)on diagnostic angiography

• An increase in LVEF by greater that 10% from initial LVEF evaluation for repeat assessments

• The presence of significant coronary lesions, other than the index lesion of the infarction related artery

• A history of significant ventricular arrhythmia not related to index STEMI

• A history of cerebro-vascular accident or transient ischemic attack within 6 months of enrollment

• Inability to undergo apheresis procedure(i.e.: poor venous access, laboratory abnormalities

• A history of uncorrected significant valvular heart disease

• A history of left ventricular dysfunction prior to index STEMI

• A history of human immunodeficiency virus (HIV)or hepatitis B or C infection

• A history of malignancy within 5 years (Except for low-grade and fully resolved non-melanoma skin cancer)

• A history of allergy to gentamycin or amphotericin

• A history of non-compliance

• Active inflammatory autoimmune disease requiring chronic immunosuppressive therapy

• Creatinine clearance <60 by Cockcroft-Gault Calculator

• Confirmed pregnant or lactating

• Is enrolled in a current investigational drug or device trial

• Participant has received cell or gene therapy in past

• The presence of any significant co-morbidities that, in the investigator's opinion, would preclude the participant from taking part in the trial

• Inability to provide informed consent and comply with the follow-up visit schedule