Clinical trial NCT01872624: Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema
Official title: Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Emphysema
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
name: National Research Council, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Universidade Federal do Rio de Janeiro
name: Pontifícia Universidade Católica do Paraná
First posted: 2013-06-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Absence of lung deficits during the procedure and/or in the 4 months follow-up
timeFrame: 4 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 120 days
measure: Pulmonary function
timeFrame: 120 days
measure: Inflammation
timeFrame: 120 days
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Pontificia Universidade Catolica do Parana
state: PR
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Hugo G Oliveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Patricia RM Rocco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abreu SC, Antunes MA, Pelosi P, Morales MM, Rocco PR. Mechanisms of cellular therapy in respiratory diseases. Intensive Care Med. 2011 Sep;37(9):1421-31. doi: 10.1007/s00134-011-2268-3. Epub 2011 Jun 9.
citation: de Oliveira HG, Macedo-Neto AV, John AB, Jungblut S, Prolla JC, Menna-Barreto SS, Fortis EA. Transbronchoscopic pulmonary emphysema treatment: 1-month to 24-month endoscopic follow-up. Chest. 2006 Jul;130(1):190-9. doi: 10.1378/chest.130.1.190.