CompletedNCT00257413Updated Nov 22, 2005

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

An interventional study of Transplantation of autologous endothelial progenitor cells in Idiopathic Pulmonary Arterial Hypertension, sponsored by Zhejiang University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2005-11-22.

Sponsored by Zhejiang University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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.

Conditions studied

Idiopathic Pulmonary Arterial Hypertension

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In context

Pulmonary Arterial Hypertension

761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.

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Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single

Interventions

ProcedureTransplantation of autologous endothelial progenitor cells

Study locations

1 site

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

References and documents

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. doi: 10.1089/1076327041348563. PubMed 15265294 ↗
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. PubMed 17418297 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 22, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00257413
Lead sponsor: Zhejiang University
First posted: Nov 22, 2005
Last update: Nov 22, 2005

Study contacts

junzhu chen, MD

study chair · First Affiliated Hospital of Zhejiang University

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2003. You cannot join it, but the record below documents what was studied.

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