drugset / Trial / NCT01795950
Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |