Pulmonary Hypertension: Assessment of Cell Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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

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Hypertension, Pulmonary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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eNOS transfected EPCs

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

Group Type EXPERIMENTAL

eNOS transfected EPCs will be delivered via a PA line

Intervention Type BIOLOGICAL

incremental dosing over 3 days

Interventions

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eNOS transfected EPCs will be delivered via a PA line

incremental dosing over 3 days

Intervention Type BIOLOGICAL

Other Intervention Names

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eNOS transfect EPCs

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No