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Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Zhejiang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT00372346
First received: September 5, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

Experimental data suggest that transplantation of endothelial progenitor cells (EPCs) attenuates monocrotaline-induced pulmonary hypertension in rats and dogs. In addition, clinical studies suggest that autogolous progenitor cells transplantation is feasible and safe in patients with ischemic disease. This study will investigate the feasibility, safety, and initial clinical outcome of intravenous infusion of autologous EPCs in patients with idiopathic pulmonary arterial hypertension.


Condition Intervention
Idiopathic Pulmonary Arterial Hypertension
 Procedure: Transplantation of autologous endothelial progenitor cells

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zhejiang University:

Estimated Enrollment: 40
Study Start Date: June 2006
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of idiopathic pulmonary arterial hypertension

    1. in New York Heart Association (NYHA) functional class II to III
    2. a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization
    3. the ability to walk ≥50 m during a standardized 6-minute walk test

Exclusion Criteria:

  • Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, NYHA functional class IV, major bleeding requiring blood transfusion, diabetes, renal dysfunction, and evidence for malignant diseases were excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372346

Contacts
Contact: xingxiang wang 8657187236500 wangxx0571@yahoo.com.cn

Locations
China, Zhejiang
Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: junzhu chen, MD     8657187236889     chenjz01@163.com    
Principal Investigator: junhui zhu, MD            
Sponsors and Collaborators
Zhejiang University
Investigators
Study Chair: junzhu chen, MD the First Affiliated Hospital, College of Medicine, Zhejiang University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00372346     History of Changes
Other Study ID Numbers: 419000－X90305
Study First Received: September 5, 2006
Last Updated: September 5, 2006
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
 Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013