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Pulmonary Hypertension: Assessment of Cell Therapy (PHACeT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00469027
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : October 17, 2016
Sponsor:
Collaborators:
Unity Health Toronto
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by (Responsible Party):
Northern Therapeutics

Study Description
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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 treatment.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Biological: eNOS transfected EPCs will be delivered via a PA line Phase 1

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 additional three patients will be entered into the final dose panel to establish safety at the maximum tolerated dose.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : May 2006
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: eNOS transfected EPCs
eNOS transfected EPCs will be delivered by injection via a PA line, incremental doses over three days
 Biological: eNOS transfected EPCs will be delivered via a PA line
incremental dosing over 3 days
Other Name: eNOS transfect EPCs


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469027


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Northern Therapeutics
Unity Health Toronto
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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Principal Investigator: John Granton, MD St. Michael's Hospital and University Health Network
Principal Investigator: David Langleben, MD Sir Mortimer B. Davis - Jewish General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Northern Therapeutics
ClinicalTrials.gov Identifier: NCT00469027    
Other Study ID Numbers: CT-PAH 001
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by Northern Therapeutics:
Pulmonary Arterial Hypertension (PAH)
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases