Pulmonary Hypertension: Assessment of Cell Therapy - Full Text View

Pulmonary Hypertension: Assessment of Cell Therapy (PHACeT)

This study is currently recruiting participants.

Verified by Northern Therapeutics, January 2009

First Received: May 2, 2007 Last Updated: January 8, 2009 History of Changes

Sponsors and Collaborators:	Northern Therapeutics St. Michael's Hospital, Toronto Sir Mortimer B. Davis - Jewish General Hospital
Information provided by:	Northern Therapeutics
ClinicalTrials.gov Identifier:	NCT00469027

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	Genetic: Transfected cells will be delivered via a PA line	Phase I

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment, Bio-availability Study
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

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 ]

Estimated Enrollment:	18
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

incremental dosing over 3 days

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

Contacts

Contact: Nancy Camack, RN BScN MBA	416-864-6060 ext 2857	camackn@smh.toronto.on.ca
Contact: Nancy Camack, RN BScN MBA	613-798-5555 ext 16623	ncamack@ohri.ca

Locations

Canada, Ontario
St. Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Nancy Camack, RN BScN MBA 416-864-6060 ext 2857 camackn@smh.toronto.on.ca
Principal Investigator: Michael Ward, MD
Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital	Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: David Langleben, MD 514-340-7531 david.langleben@mcgill.ca
Contact: Lyda Lesenko, RN 514-340-8222 ext 2833 llesenko@cardio.jgh.mcgill.ca
Principal Investigator: David Langleben, MD

Sponsors and Collaborators

Northern Therapeutics

St. Michael's Hospital, Toronto

Sir Mortimer B. Davis - Jewish General Hospital

Investigators

Principal Investigator:	Michael Ward, MD	St. Michael's Hospital, Toronto
Principal Investigator:	David Langleben, MD	Sir Mortimer B. Davis - Jewish General Hospital

More Information

No publications provided

Responsible Party:	Northern Therapeutics Inc. ( Dr. Duncan Stewart, Chief Executive Officer )
Study ID Numbers:	CT-PAH 001
Study First Received:	May 2, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00469027 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Northern Therapeutics:

Pulmonary Arterial Hypertension (PAH)

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Idiopathic Pulmonary Hypertension
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 06, 2009