Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Pulmonary Emphysema

Treatments: Procedure: Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01872624

13-0150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups, including a placebo group

Valves plus cells

Active Comparator group

Description:

Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves.

Treatment:

Procedure: Bronchoscopy

Valves plus saline

Placebo Comparator group

Description:

Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion.

Treatment:

Procedure: Bronchoscopy