Safety Study of Adenovirus Hepatocyte Growth Factor to Treat Ischemic Heart Disease
NCT ID: NCT01925352
Last Updated: 2013-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2012-11-30
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ad-HGF
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.
Ad-HGF
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
Interventions
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Ad-HGF
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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Academy Military Medical Science, China
INDUSTRY
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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zhijian yang
Professor
Principal Investigators
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Zhijian Yang, PhD.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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Jiangsu Province Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Dingguo Zhang, PhD
Role: primary
Other Identifiers
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HIHD
Identifier Type: -
Identifier Source: org_study_id