Pulmonary Hypertension: Assessment of Cell Therapy

Plain-language summary

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.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Northern Therapeutics

Intervention

eNOS transfected EPCs will be delivered via a PA line (eNOS transfect EPCs)

Start date

5/1/2006

Estimated completion

7/1/2012

Countries

Canada

Related genes

Locations

• Toronto, Canada
• Montreal, Canada

Eligibility criteria

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