Pulmonary Hypertension: Assessment of Cell Therapy
Completed
- Conditions
- Idiopathic pulmonary arterial hypertensionCirculatory SystemPulmonary arterial hypertension
- Registration Number
- ISRCTN14519481
- Lead Sponsor
- orthern Therapeutics Inc (Canada)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
1. Age >=18 years and <=80 years
2. Clinical diagnosis of idiopathic PAH
3. Familial PAH or anorexigen-induced PAH
4. Specified 6-minute walk distance
Exclusion Criteria
1. Intra or extra cardiac communication between the right- and left-sided circulations
2. Hemodynamic instability
3. Left ventricular ejection fraction <=40%
4. Thromboembolic event or recent hospitalisation for worsening right-sided heart failure in last three months
5. Central venous pressure (CVP) >20 mmHg at time of research heart catheterisation
6. Pregnancy
7. Concurrent hepatitis or HIV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Tolerability and safety of the injection of genetically engineered progenitor cells in patients with severe PAH<br>2. Clinically significant changes in hemodynamic parameters<br>3. Time to clinical worsening<br>4. Contrast echo assessment of pulmonary arterial-venous shunting<br>5. Pulmonary function with diffusing capacity of the lung for carbon monoxide (DLCO)<br>6. Changes in ventilation perfusion scan<br>7. Dypnea by Borg index<br>8. Immune surveillance<br>9. Human nitric oxide synthase (heNOS) plasmid detection in systemic arterial blood pre- and post-cell delivery
- Secondary Outcome Measures
Name Time Method Potential efficacy of this approach will be assessed by changes in hemodynamic pressures, patient perceived quality of life and exercise capacity.