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

Zhejiang University logo

Zhejiang University

Status

Completed

Conditions

Idiopathic Pulmonary Arterial Hypertension

Treatments

Procedure: Transplantation of autologous endothelial progenitor cells

Study type

Interventional

Funder types

Other

Identifiers

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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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