Status:
COMPLETED
Pulmonary Hypertension: Assessment of Cell Therapy
Lead Sponsor:
Northern Therapeutics
Collaborating Sponsors:
Unity Health Toronto
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 treat...
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...
Eligibility Criteria
Inclusion
- Clinical diagnosis of idiopathic Pulmonary Arterial Hypertension
- Familial PAH or anorexigen induced PAH
- Specified 6-minute walk distance
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00469027
Start Date
May 1 2006
End Date
July 1 2012
Last Update
October 17 2016
Active Locations (2)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
2
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2