Back to resultsSafety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension
Primary Purpose
Idiopathic Pulmonary Arterial Hypertension
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transplantation of autologous endothelial progenitor cells
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of idiopathic pulmonary arterial hypertension in New York Heart Association (NYHA) functional class II to III a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization 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
Sites / Locations
- Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00257413
First Posted
November 21, 2005
Last Updated
November 21, 2005
Sponsor
Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT00257413
Brief Title
Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Zhejiang University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Transplantation of autologous endothelial progenitor cells
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of idiopathic pulmonary arterial hypertension
in New York Heart Association (NYHA) functional class II to III
a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
junzhu chen, MD
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
15265294
Citation
Takahashi M, Nakamura T, Toba T, Kajiwara N, Kato H, Shimizu Y. Transplantation of endothelial progenitor cells into the lung to alleviate pulmonary hypertension in dogs. Tissue Eng. 2004 May-Jun;10(5-6):771-9. doi: 10.1089/1076327041348563.
Results Reference
background
PubMed Identifier
17418297
Citation
Wang XX, Zhang FR, Shang YP, Zhu JH, Xie XD, Tao QM, Zhu JH, Chen JZ. Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial. J Am Coll Cardiol. 2007 Apr 10;49(14):1566-71. doi: 10.1016/j.jacc.2006.12.037. Epub 2007 Mar 27.
Results Reference
derived
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Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension
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