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

This study has been completed.

Sponsor:

Information provided by:

Zhejiang University

ClinicalTrials.gov Identifier:

NCT00257413

First received: November 21, 2005

Last updated: NA

Last verified: December 2003

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 21, 2005

Last Updated Date

November 21, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Pulmonary Arterial Hypertension

Intervention ^ICMJE

Procedure: Transplantation of autologous endothelial progenitor cells

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00257413

Other Study ID Numbers ^ICMJE

A-007

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Zhejiang University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

junzhu chen, MD

the First Affiliated Hospital, College of Medicine, Zhejiang University

Information Provided By

Zhejiang University

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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