Trials / Completed
CompletedNCT01872624
Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema
Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Hospital de Clinicas de Porto Alegre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal cells in patients with severe pulmonary emphysema is safe and will contribute to increase quality of life.
Detailed description
In addition to testing the safety of one-way endobronchial valves combined with bone-marrow derived mesenchymal stromal cells, the study will determine the systemic inflammatory potential of cell therapy measured by C-reactive protein levels (CRP), erythrocyte sedimentation rate (ESR) and complete blood count in peripheral blood. Finally, the study will aim at determining if other markers of inflammatory response and remodeling are modulated by this therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bronchoscopy | Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells. |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-12-01
- Completion
- 2015-03-01
- First posted
- 2013-06-07
- Last updated
- 2015-03-25
Locations
3 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01872624. Inclusion in this directory is not an endorsement.