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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
intravenous administration of a single dose of PLX-PAD cells
The Prince Charles Hospital
Brisbane, Queensland, Australia
The Alfred Hospital
Melbourne, Australia
Incidence of treatment-emergent AEs (frequency and severity at each dose level)
Time frame: 12 weeks
Incidence of SAEs
Time frame: 1 year
Change in Six Minute Walk distance
Time frame: Baseline and 6 weeks
Change in Dyspnea Score
Change in maximum level of dyspnea experienced during the six minute walk test using a 10 point scale.
Time frame: Baseline and 6 weeks
Change in WHO Functional Classification
Time frame: Baseline and 6 weeks
Change in Plasma NT-pro-BNP levels
Time frame: Baseline and 6 weeks
Change from Baseline in echocardiography parameters
Change in RV area at end systole and end diastole (for calculation of estimated RV ejection fraction, RV basal and mid diameter at end systole and end diastole, RV free wall thickness, tricuspid annular plane systolic excursion (TAPSE), maximal tricuspid regurgitant jet velocity TRJV) and pulmonary artery end diastolic pressure (PAEDP)
Time frame: Baseline and 6 weeks
Change in cardiopulmonary hemodynamics
mean pulmonary arterial pressure (PAPm), heart rate (HR), systolic systemic arterial pressure (SAPs), diastolic systemic arterial pressure (SAPd), mean systemic arterial pressure (SAPm), pulmonary artery systolic pressure (PAPs), pulmonary artery diastolic pressure (PAPd), mean right atrial pressure (RAPm), mean pulmonary capillary wedge pressure (PCWPm), and cardiac output (CO)
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Time frame: Baseline and 6 weeks