drugset / Trial / NCT01795950

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

NCT01795950 ↗

Phase 1 Terminated 6 enrolled United Therapeutics
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-04
Primary completion
2015-12
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject EMIPLACEL Cell therapy 500000 cells/kg Intravenous
Subject EMIPLACEL Cell therapy 1e+06 cells/kg Intravenous
Subject EMIPLACEL Cell therapy 2e+06 cells/kg Intravenous