NCT00257413

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2005

Completed
Last Updated

November 22, 2005

Status Verified

December 1, 2003

First QC Date

November 21, 2005

Last Update Submit

November 21, 2005

Conditions

Idiopathic Pulmonary Arterial Hypertension

Interventions

Transplantation of autologous endothelial progenitor cellsPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (2)

  • 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.

    PMID: 15265294BACKGROUND

  • 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.

    PMID: 17418297DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • junzhu chen, MD

    First Affiliated Hospital of Zhejiang University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2005

First Posted

November 22, 2005

Last Updated

November 22, 2005

Record last verified: 2003-12

Locations

CN(1)