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

August 19, 2013 updated by: zhijian yang, The First Affiliated Hospital with Nanjing Medical University

Phase 2 Study of Adenovirus Hepatocyte Growth Factor for Treatment of Ischemic Heart Disease

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ad-HGF
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
Other Names:
  • adenovirs hepatocyte growth factor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with death,new myocardial infarction or stroke
Time Frame: 6 months after treatment
6 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
left ventricular ejection fraction (LVEF)
Time Frame: 6 months after treatment
6 months after treatment

Other Outcome Measures

Outcome Measure
Time Frame
tumor markers of blood
Time Frame: 6 months after treatment
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Academy Military Medical Science, China

Investigators

  • Principal Investigator: Zhijian Yang, PhD., The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Estimate)

August 20, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIHD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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