- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00372346
Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension
September 5, 2006 updated by: Zhejiang University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: xingxiang wang
- Phone Number: 8657187236500
- Email: wangxx0571@yahoo.com.cn
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Recruiting
- Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
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Contact:
- junzhu chen, MD
- Phone Number: 8657187236889
- Email: chenjz01@163.com
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Principal Investigator:
- junhui zhu, MD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: junzhu chen, MD, First Affiliated Hospital of Zhejiang University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion
December 1, 2007
Study Registration Dates
First Submitted
September 5, 2006
First Submitted That Met QC Criteria
September 5, 2006
First Posted (Estimate)
September 6, 2006
Study Record Updates
Last Update Posted (Estimate)
September 6, 2006
Last Update Submitted That Met QC Criteria
September 5, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 419000-X90305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Pulmonary Arterial Hypertension
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American Medical Association FoundationWithdrawnIdiopathic Pulmonary Arterial Hypertension.United States
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