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

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

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Zhejiang University:

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257413

Locations

China, Zhejiang
Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003

Sponsors and Collaborators

Zhejiang University

Investigators

Study Chair:

junzhu chen, MD

the First Affiliated Hospital, College of Medicine, Zhejiang University

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2007 Mar 27.

ClinicalTrials.gov Identifier:	NCT00257413 History of Changes
Other Study ID Numbers:	A-007
Study First Received:	November 21, 2005
Last Updated:	November 21, 2005
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 19, 2013

To Top