Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema (BLVR)

Mansoura University

Status and phase: Completed; Phase 2

Conditions: Pulmonary Emphysema

Treatments: Procedure: Bronchoscopic Lung volume reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT02107209

MD68

Details and patient eligibility

About

The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.

Full description

Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation.

Enrollment: 15 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Emphysema determined by HRCT of the chest with:

   • .Persistent symptoms (i.e. a baseline Modified Medical Research Council dyspnea (MRC) score of >2 despite medical therapy).
   • FEV1 /FVC < 70% and FEV1 20%-50 % (Sever and very sever airflow limitation according to GOLD 2013).
   • Hyperinflation (total lung capacity (TLC) > 110% pred and residual volume/total lung capacity (RV/TLC) > 120% pred.

2. Patients not candidate for or had refused lung volume reduction surgery.

3. Age > 40 yrs.

Exclusion criteria

1. Airflow limitation with FEV1 < 20%.
2. DLCO < 20%.
3. Current smoker.
4. Patients not candidate for FOB.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Bronchoscopic Lung volume reduction using Autologous blood.

Experimental group

Description:

Injection of 30 ml autologous blood plus 3ml calcium chloride plus 3 ml tranexamic acid per segment via fiber-optic bronchoscope

Treatment:

Procedure: Bronchoscopic Lung volume reduction

Bronchoscopic Lung volume reduction using Fibrin glue

Active Comparator group

Description:

injection of 30 ml locally prepared fibrin glue per segment via triple lumen balloon catheter passing through fiberoptic bronchoscopy

Treatment:

Procedure: Bronchoscopic Lung volume reduction