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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00641836
Other study ID # IPAH-EPC-2
Secondary ID
Status Completed
Phase N/A
First received March 18, 2008
Last updated March 18, 2008
Start date July 2005
Est. completion date December 2007

Study information

Verified date March 2008
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Transplantation of autologous endothelial progenitor cells


Locations

Country Name City State
China Department of Cardiology, the First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang XX, Zhang FR, Shang YP, Zhu JH, Xie XD, Tao QM, Zhu JH, Chen JZ. Transplantation of autologous endothelial progenitor cells may be beneficial in patients with idiopathic pulmonary arterial hypertension: a pilot randomized controlled trial. J Am Coll — View Citation

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