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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT00469027 |
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Date of registration:
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02/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pulmonary Hypertension: Assessment of Cell Therapy
PHACeT |
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Scientific title:
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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 |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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7 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00469027 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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Contacts
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Name:
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John Granton, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Michael's Hospital and University Health Network |
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Name:
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David Langleben, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sir Mortimer B. Davis - Jewish General Hospital |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Biological: eNOS transfected EPCs will be delivered via a PA line
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Primary Outcome(s)
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The primary endpoints will be related to the tolerability and safety of injection of genetically engineered progenitor cells in patients with severe PAH.
[Time Frame: 5 years]
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Secondary Outcome(s)
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Potential efficacy of this approach will be assessed by changes in hemodynamic pressures, patient perceived quality of life and exercise capacity
[Time Frame: 3 month post cell delivery]
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Secondary ID(s)
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CT-PAH 001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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