- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641836
Safety and Feasibility of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension
March 18, 2008 updated by: Zhejiang University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
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 Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University
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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:
- 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
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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
July 1, 2005
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
March 18, 2008
First Submitted That Met QC Criteria
March 18, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
March 24, 2008
Last Update Submitted That Met QC Criteria
March 18, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPAH-EPC-2
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.
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