Status:
COMPLETED
Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Ministry of Health, Brazil
National Research Council, Brazil
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ther...
Eligibility Criteria
Inclusion
- Diagnosis of severe heterogeneous emphysema (heterogeneity \> 15%), with heterogeneity defined as the difference between lobes in the percent area covered by parenchymal density greater than -950 Hounsfield Units.
- Estimation of collateral ventilation based on fissure with integrity ≥ 75%.
- Total lung capacity\> 100% predicted.
- Residual volume\> 150% predicted.
- Forced expiratory volume at the first minute \<45% predicted.
- Diffusing capacity of the lungs for carbon monoxide \<45% predicted.
- Optimal medical treatment.
- Limitations in daily physical activities.
- Minimum of 4 months without smoking
- Having family support.
- Stage ≥ 2 in modified Medical Research Council Dyspnea Scale (MMRC).
Exclusion
- Homogenous emphysema.
- Presence of collateral ventilation.
- Use of systemic corticosteroids (prednisone\> 20mg/day or equivalent).
- Pulmonary or extrapulmonary infection.
- Coronary heart disease and/or severe ventricular dysfunction.
- Significant renal or liver disease.
- Immunosuppressive disease.
- Active smoking.
- Cancer prognosis with survival \<2 years.
- Psychosocial problems.
- Pregnancy.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01872624
Start Date
May 1 2013
End Date
March 1 2015
Last Update
March 25 2015
Active Locations (3)
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1
Pontificia Universidade Catolica do Parana
Curitiba, Paraná, Brazil, 80215-901
2
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil, 21941-902
3
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003