Pulmonary Hypertension: Assessment of Cell Therapy (PHACeT)

This study has been completed.
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Sir Mortimer B. Davis - Jewish General Hospital
Information provided by (Responsible Party):
Northern Therapeutics
ClinicalTrials.gov Identifier:
NCT00469027
First received: May 2, 2007
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Hypertension, Pulmonary
Biological: Transfected cells will be delivered via a PA line
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Northern Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: May 2006
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eNOS transfected EPCs Biological: Transfected cells will be delivered via a PA line
incremental dosing over 3 days
Other Name: eNOS transfect EPCs

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469027

Locations
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
St. Michael's Hospital, Toronto
Sir Mortimer B. Davis - Jewish General Hospital
Investigators
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

No publications provided by Northern Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Northern Therapeutics
ClinicalTrials.gov Identifier: NCT00469027     History of Changes
Other Study ID Numbers: CT-PAH 001
Study First Received: May 2, 2007
Last Updated: March 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by Northern Therapeutics:
Pulmonary Arterial Hypertension (PAH)

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014