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

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ClinicalTrials.gov Identifier: NCT00372346
Recruitment Status : Unknown
Verified August 2006 by Zhejiang University.
Recruitment status was:  Recruiting
First Posted : September 6, 2006
Last Update Posted : September 6, 2006
Sponsor:
Information provided by:
Zhejiang University

Brief Summary:
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 or disease Intervention/treatment Phase
Idiopathic Pulmonary Arterial Hypertension Procedure: Transplantation of autologous endothelial progenitor cells Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 2006
Study Completion Date : December 2007






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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00372346     History of Changes
Other Study ID Numbers: 419000-X90305
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: September 6, 2006
Last Verified: August 2006

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