NCT01795950

Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)

A Phase I Safety and Pharmacodynamic Study of Intravenous Infusion of PLX-PAD Cells in Patients With PAH

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	PLX-PAD	intravenous administration of a single dose of PLX-PAD cells

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2013-02-21
• Last updated: 2016-02-17

Locations

2 sites across 1 country: Australia