We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641836
First Posted: March 24, 2008
Last Update Posted: March 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zhejiang University
  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
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 18, 2008
First Posted: March 24, 2008
Last Update Posted: March 24, 2008
Last Verified: March 2008

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