Text Size

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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Zhejiang University:

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641836

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

Publications:

ClinicalTrials.gov Identifier: NCT00641836     History of Changes
Other Study ID Numbers: IPAH-EPC-2
Study First Received: March 18, 2008
Last Updated: March 18, 2008
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
 Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013