Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469027
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2007-05-02
Brief Title:
Pulmonary Hypertension Assessment of Cell Therapy
Sponsor:
Northern Therapeutics
Organization:
Northern Therapeutics
Study Overview
Official Title:
Phase I Trial to Establish Safety of Autologous Progenitor Cell-based Gene Therapy Delivery of heNOS in Patients With Severe Pulmonary Arterial HypertensionPAHRefractory to Conventional Treatment
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHACeT
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 HypertensionPAH refractory to conventional treatment
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None