Safety Study of Adenovirus Hepatocyte Growth Factor to Treat Ischemic Heart Disease
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|ClinicalTrials.gov Identifier: NCT01925352|
Recruitment Status : Unknown
Verified August 2013 by zhijian yang, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : August 19, 2013
Last Update Posted : August 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease||Drug: Ad-HGF||Phase 1 Phase 2|
- Ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Adenovirus Hepatocyte Growth Factor for Treatment of Ischemic Heart Disease|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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.
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
Other Name: adenovirs hepatocyte growth factor
- Number of participants with death,new myocardial infarction or stroke [ Time Frame: 6 months after treatment ]
- left ventricular ejection fraction (LVEF) [ Time Frame: 6 months after treatment ]
- tumor markers of blood [ Time Frame: 6 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925352
|Contact: Dingguo Zhang, PhD.||86-25-83718836 ext email@example.com|
|Jiangsu Province Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Dingguo Zhang, PhD 86-25-83718836 ext 6640 firstname.lastname@example.org|
|Principal Investigator:||Zhijian Yang, PhD.||The First Affiliated Hospital with Nanjing Medical University|