increased pulmonary artery pressure pulmonary arterial hypertension
Conditions
Interventions
Bone marrow will be aspirated from the iliac crest. Expanded mesenchymal stem
cells will be administrated intravenously and reach the pulmonary circulation
through the the right side of the heart.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Pulmonary arterial hypertension, defined as a mean pulmonary artery pressure (mPAP) *25mmHg at rest with a pulmonary capillary wedge pressure (PCWP) of
Exclusion criteria
Exclusion criteria: - Evidence of cancer in past 5 years (except low grade and fully resolved non-melanoma skin malignancy) - Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before the administration procedure. - Suspected presence of pulmonary hypertension caused by left heart disease resulting in an increased wedge pressure (group II,Nice 2013(8)) - Suspected presence of pulmonary hypertension due to pulmonary disease and/or hypoxia (group III, Nice 2013 (8)), as assessed by our PAH working group. - Other severe concurrent illnesses (including active infection). - Bleeding diathesis, infection with the human immunodeficiency virus (HIV) or pregnancy. - Any other condition that, in the opinion of the investigator, could pose a significant threat to the subject if the investigational therapy would be initiated. - Inability to undergo cardiac catheterization. - Inability to follow the protocol and comply with follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The administration of autologous bone marrow-derived in vitro expanded mesenchymal stem cells will be considered feasible if all the procedures in the protocol can be performed as described. Safety will be reflected as the rate of (serious) adverse events in the study population during a follow up of 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary efficacy will be described as change in quality of life, functional class, exercise capacity, pro-brain natriuretic peptide levels, electrocardiographic and echocardiographic characteristics, and pulmonary function and pulmonary pressure measurements before and after the procedure. | — |
Countries
Netherlands
Outcome results
None listed