Safety Study of Adenovirus Hepatocyte Growth Factor to Treat Ischemic Heart Disease

Nanjing Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Ischemic Heart Disease

Treatments: Drug: Ad-HGF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01925352

HIHD

Details and patient eligibility

About

To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment in ischemic heart disease.

Full description

1. Ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply.
2. Gene therapy offers an attractive alternative to current pharmacologic therapies and may be beneficial in refractory disease. Gene therapy with hepatocyte growth factor induces angiogenesis, decreases apoptosis and leads to protection in the ischemic heart. In this study, we mainly explore the safety and effects of adenovirus hepatocyte growth factor for the treatment of ischemic heart disease.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• person with ischemic heart disease;
• Male or female of 20 to 70 years old;
• No blood perfusion detected in some area of heart using Single-Photon Emission Computed Tomography(SPECT) or Magnetic Resonance Imaging(MRI)
• two or more than two coronary arteries lesions were detected using coronary artery angiography and at least one coronary artery are un-suitable for percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG)；Or patients refuse to perform PCI or CABG
• LVEF is ≤45%;
• Patients must sign approved informed consent.

Exclusion criteria

• Acute myocardial infarction occured within one week
• CABG performed within 6 months or PCI performed within 3 months
• Patients with systemic active infection
• Blood alanine aminotransferase (ALT)>135mmol/L or blood crea(Cr)>200umol/L or patients with chronic obstructive pulmonary disease (COPD)
• patients with obvious bleeding tendency and blood disease
• patients with malignant tumor or end-stage disease
• patient anticipated life expectancy is less than 12 months
• patient recently attended test drugs or other device research

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ad-HGF

Experimental group

Description:

5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection in patients with ischemic heart disease into five left ventricular sites once.

Treatment:

Drug: Ad-HGF