Ad-HGF Treatment for Myocardial Infarction

Nanjing Medical University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Myocardial Infarction

Treatments

Drug: Ad-HGF

Other: 0.9% NaCl

Study type

Interventional

Funder types

Other

Identifiers

NCT02844283

2016-6-29

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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