Trial | NCT00469027  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    7
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.
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.
Study Started
May 31
2006
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
Oct 17
2016
Estimate

Biological eNOS transfected EPCs will be delivered via a PA line

incremental dosing over 3 days

  • Other names: eNOS transfect EPCs

eNOS transfected EPCs Experimental

eNOS transfected EPCs will be delivered by injection via a PA line, incremental doses over three days

Criteria 

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
No Results Posted