Idiopathic pulmonary arterial hypertension Circulatory System Pulmonary arterial hypertension
Conditions
Interventions
A total of 18 patients will be studied using an open-label, dose-escalating 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.
Apheresis
Sponsors
Northern Therapeutics Inc (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Intra or extra cardiac communication between the right- and left-sided circulations 2. Hemodynamic instability 3. Left ventricular ejection fraction 20 mmHg at time of research heart catheterisation 6. Pregnancy 7. Concurrent hepatitis or HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tolerability and safety of the injection of genetically engineered progenitor cells in patients with severe PAH 2. Clinically significant changes in hemodynamic parameters 3. Time to clinical worsening 4. Contrast echo assessment of pulmonary arterial-venous shunting 5. Pulmonary function with diffusing capacity of the lung for carbon monoxide (DLCO) 6. Changes in ventilation perfusion scan 7. Dypnea by Borg index 8. Immune surveillance 9. Human nitric oxide synthase (heNOS) plasmid detection in systemic arterial blood pre- and post-cell delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Potential efficacy of this approach will be assessed by changes in hemodynamic pressures, patient perceived quality of life and exercise capacity. | — |
Countries
Canada
Outcome results
None listed