Safety and Efficacy Study of Transplantation of EPCs to Treat Idiopathic Pulmonary Arterial Hypertension

Zhejiang University

Status: Unknown

Conditions: Idiopathic Pulmonary Arterial Hypertension

Treatments: Procedure: Transplantation of autologous endothelial progenitor cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00372346

419000-X90305

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of idiopathic pulmonary arterial hypertension

  1. in New York Heart Association (NYHA) functional class II to III
  2. a mean pulmonary artery pressure more than 30 mmHg on right heart catheterization
  3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind