NCT00469027

Pulmonary Hypertension: Assessment of Cell Therapy

Phase I Trial to Establish Safety of Autologous Progenitor Cell-based Gene Therapy Delivery of heNOS in Patients With Severe Pulmonary Arterial Hypertension(PAH)Refractory to Conventional Treatment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Northern Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to establish the safety of autologous progenitor cell-based gene therapy of heNOS in patients with severe Pulmonary Arterial Hypertension(PAH) refractory to conventional treatment.

Detailed description

This is a two centre, phase I clinical trial. A total of 18 patients will be studied using an open-label, dose escaling protocol; three patients will be entered into each of the five dosing panels. An additional three patients will be entered into the final dose panel to establish safety at the maximum tolerated dose.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
BIOLOGICAL	eNOS transfected EPCs will be delivered via a PA line	incremental dosing over 3 days

Timeline

• Start date: 2006-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2007-05-04
• Last updated: 2016-10-17

Locations

2 sites across 1 country: Canada