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Completed

NCT Number: NCT00469027

Pulmonary Hypertension: Assessment of Cell Therapy

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.

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Key information

Conditions

Hypertension, Pulmonary Cardiovascular Diseases Hypertension Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eNOS transfected EPCs will be delivered via a PA line

Biological

incremental dosing over 3 days

Other names: eNOS transfect EPCs

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Northern Therapeutics

Industry

Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital
  • Unity Health Toronto

Registry information

Official study 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

Acronym: PHACeT

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
May 4, 2007
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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