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

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborator: Academy Military Medical Science, China
• Treatments: Mitogens

Criteria

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