This study evaluated the safety of gene therapy in which a patient's own progenitor cells carrying the heNOS gene are delivered through a pulmonary artery line, in people with severe pulmonary arterial hypertension (PAH) that does not respond to conventional treatment. This Phase 1 trial enrolled patients with idiopathic, familial or anorexigen-induced PAH.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Clinical diagnosis of idiopathic Pulmonary Arterial Hypertension * Familial PAH or anorexigen induced PAH * Specified 6-minute walk distance Exclusion Criteria: * Intra or extra cardiac communication between the right and left sided circulations * Hemodynamic instability * Left ventricular ejection fraction \< 40% * Thromboembolic event or recent hospitalization for worsening right sided heart failure in past 3 months * CVP\>20mmHg at time of research heart catheterization * Pregnancy * Concurrent hepatitis or HIV