Ignite Creation Date:
2024-05-06 @ 1:22 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01795950
Status:
TERMINATED
Last Update Posted:
2016-02-17
First Post:
2013-02-12
Brief Title:
Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension PAH
Sponsor:
United Therapeutics
Organization:
United Therapeutics
Study Overview
Official Title:
A Phase I Safety and Pharmacodynamic Study of Intravenous Infusion of PLX-PAD Cells in Patients With PAH
Status:
TERMINATED
Status Verified Date:
2016-02
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:
None
Brief Summary:
The purpose of this clinical study is to assess the safety of PLX-PAD to treat pulmonary arterial hypertension PAH PLX-PAD is a cell-based product made of allogeneic Mesenchymal-like Adherent Stromal Cells ASCs derived from human full-term placentas following an elective caesarean section This year-long study will evaluate the safety of three different dose levels of PLX-PAD each given as a single intravenous infusion This study will also evaluate effects that PLX-PAD may have on PAH such as changes in the ability to exercise and on other tests used to measure the disease severity
Detailed Description:
None
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