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

• ClinicalTrials.gov Identifier: NCT00257413
• Recruitment Status: Completed
• First Posted: November 22, 2005
• Last Update Posted: November 22, 2005
• Sponsor: Zhejiang University
• Information provided by: Zhejiang University

Tracking Information

• First Submitted Date: November 21, 2005
• First Posted Date: November 22, 2005
• Last Update Posted Date: November 22, 2005
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension
• Official Title: Not Provided
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single; Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Arterial Hypertension
• Intervention: Procedure: Transplantation of autologous endothelial progenitor cells
• Study Arms: Not Provided

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00257413
• Other Study ID Numbers: A-007
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Zhejiang University
• Collaborators: Not Provided

Investigators

• Study Chair: junzhu chen, MD; First Affiliated Hospital of Zhejiang University

• PRS Account: Zhejiang University
• Verification Date: December 2003