Status:
TERMINATED
Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
United Therapeutics
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 Strom...
Eligibility Criteria
Inclusion
- Summary of inclusion and exclusion criteria.
- Eligible subjects:
- Are between 18 and 75 years of age
- Have a minimum weight of 45 kg
- Have a diagnosis of idiopathic or heritable PAH, PAH associated with connective tissue disease (CTD), PAH associated with repaired congenital systemic-to-pulmonary cardiac shunt (at least one year since repair), or PAH associated with appetite suppressant/drug or toxin use confirmed by RHC
- Have a current WHO functional class II or III designation
- Have been stabilized, without dose changes for at least 30 days prior to the Screening visit on at least two approved PAH medications (e.g., PDE-5 inhibitor, ERA, prostanoid \[as inhalation or infusion\]); or IV prostanoid monotherapy. Subjects on an IV prostanoid must have been receiving therapy for at least three months prior to the Screening visit.
- Have a 6MWD equal to or greater than 200 meters (m) at the Screening and Baseline Visits.
- Subjects must not:
- Have any evidence of pulmonary thrombus, significant coronary artery disease (CAD), left ventricular dysfunction, or a restrictive or congestive cardiomyopathy
- Have a history of malignancies within the past 5 years,with the exception of individuals with localized, non-metastatic basal cell carcinoma of the skin, in situ carcinoma of the cervix, or prostate cancer who are not currently or expected to undergo radiation therapy, chemotherapy and/or surgical intervention, or to initiate hormonal treatment during the study
- Be listed for transplantation
- Be pregnant or nursing
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01795950
Start Date
April 1 2013
End Date
January 1 2016
Last Update
February 17 2016
Active Locations (2)
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1
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032
2
The Alfred Hospital
Melbourne, Australia