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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.
Information provided by:
Zhejiang University Identifier:
First received: March 18, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
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.

Condition Intervention
Idiopathic Pulmonary Arterial Hypertension
Procedure: Transplantation of autologous endothelial progenitor cells

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: One-Year Follow-Up of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

Resource links provided by NLM:

Further study details as provided by Zhejiang University:

Enrollment: 98
Study Start Date: July 2005
Study Completion Date: December 2007

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00641836

China, Zhejiang
Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Zhejiang University
Principal Investigator: Junzhu Chen, MD the First Affiliated Hospital, College of Medicine, Zhejiang University
  More Information

Publications: Identifier: NCT00641836     History of Changes
Other Study ID Numbers: IPAH-EPC-2
Study First Received: March 18, 2008
Last Updated: March 18, 2008

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases processed this record on May 24, 2017