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

Idiopathic Pulmonary Arterial Hypertension Clinical Trial

Official title:

One-Year Follow-Up of Autologous Endothelial Progenitor Cells Transplantation in Patients With Idiopathic Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641836
• Other study ID #: IPAH-EPC-2
• 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
• 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

• Hypertension
• Idiopathic Pulmonary Arterial Hypertension

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