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For this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary Emcyteâ„¢ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. As circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. Here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. Several growth factors are released by activated platelets becoming honing cells for healing within the tissue. The exact long-term mechanism of action of PRP-PC in the lungs remains under investigation. Safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. Prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both COPD and ILD.
Study Objective(s) Primary
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Cellular Therapy with PRP-PC | Biological | In this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using centrifugation, then returned to the patient same day via the peripheral circulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Lung Function | Lung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life subjective | Quality of life will be measured with the Clinical COPD Questionnaire (CCQ). | 3 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-
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Conventional treatment for chronic lung disease typically involves inhaled bronchodilators, steroids, oxygen therapy, antifibrotic medications, lung reduction surgery and lung transplantation for the management of symptoms, although none of these modalities (aside from surgery/transplant) thwarts long-term progression of the disease.. With transplantation the availability of donor lungs is scarce and the longterm need for anti-rejection medication and monitoring can be overwhelming. Recent advances in the field of regenerative medicine in lung disease have demonstrated that autologous cellular therapy may reduce inflammation and aid in the maintenance and repair of damaged lung tissue
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centers for Respiratory Health | Tampa | Florida | 33602 | United States |
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