Trial record 1 of 11841 for:    United Therapeutics cell
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Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01795950
First received: February 12, 2013
Last updated: August 6, 2014
Last verified: August 2014

February 12, 2013
August 6, 2014
April 2013
March 2015   (final data collection date for primary outcome measure)
  • Incidence of treatment-emergent AEs (frequency and severity at each dose level) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of SAEs [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01795950 on ClinicalTrials.gov Archive Site
  • Change in Six Minute Walk distance [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change in Dyspnea Score [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Change in maximum level of dyspnea experienced during the six minute walk test using a 10 point scale.
  • Change in WHO Functional Classification [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change in Plasma NT-pro-BNP levels [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in echocardiography parameters [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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)
  • Change in cardiopulmonary hemodynamics [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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)
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: PLX-PAD
intravenous administration of a single dose of PLX-PAD cells
Other Name: allogeneic Mesenchymal-like Adherent Stromal Cells (ASCs)
  • Experimental: 0.5 M PLX-PAD
    0.5 million (M) PLX-PAD cells per kg body weight
    Intervention: Drug: PLX-PAD
  • Experimental: 1 M PLX-PAD
    1.0 million (M) PLX-PAD cells per kg body weight
    Intervention: Drug: PLX-PAD
  • Experimental: 2 M PLX-PAD
    2.0 million (M) PLX-PAD cells per kg body weight
    Intervention: Drug: PLX-PAD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
January 2016
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Kristan Rollins, PharmD 919-425-8167 krollins@unither.com
Australia
 
NCT01795950
PLX-PH-101
Yes
United Therapeutics
United Therapeutics
Not Provided
Principal Investigator: Daniel Chambers, MRCP FRACP MD The Prince Charles Hospital
United Therapeutics
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP