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Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

This study has been completed.
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT00641836
First received: March 18, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 18, 2008
March 18, 2008
July 2005
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No Changes Posted
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Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension
One-Year Follow-Up of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

Recent researches indicate that impairment of vascular and endothelial homeostasis plays a major role in the initiation and development of IPAH.We have recently reported the safety and feasibility data for autologous endothelial progenitor cells (EPCs) injection in patients with IPAH. Yet many questions remain unanswered: what is the ideal quantity of EPCs for therapy, the duration of the therapeutic effect, and moreover, the potential toxicity of such therapy. To help answer these questions, we designed the one year follow-up to investigate the safety and efficacy of autologous EPCs injection in patients with IPAH.
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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Pulmonary Arterial Hypertension
Procedure: Transplantation of autologous endothelial progenitor cells
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
December 2007
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Inclusion Criteria:

  • The inclusion criteria included a base-line six minute walking distance between 100 and 450 m
  • A resting mean pulmonary-artery pressure greater than 30 mm Hg
  • A pulmonarycapillary wedge pressure of less than 15 mm Hg
  • Pulmonary vascular resistance greater than 240 dyn•sec•cm-5
  • 18-60 years old

Exclusion Criteria:

  • The exclusion criteria included secondary 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
  • New York Heart Association functional class IV
  • Major bleeding requiring blood transfusion
  • Diabetes
  • Renal dysfunction
  • Evidence for malignant diseases were excluded
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00641836
IPAH-EPC-2
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Zhejiang University
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Principal Investigator: Junzhu Chen, MD the First Affiliated Hospital, College of Medicine, Zhejiang University
Zhejiang University
March 2008

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