Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

NCT ID: NCT02107209

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-08-31

Brief Summary

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.

Detailed 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.

Conditions

Pulmonary Emphysema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bronchoscopic Lung volume reduction using Autologous blood.

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

Group Type: EXPERIMENTAL

Bronchoscopic Lung volume reduction

Intervention Type: PROCEDURE

Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment

Bronchoscopic Lung volume reduction using Fibrin glue

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

Group Type: ACTIVE_COMPARATOR

Bronchoscopic Lung volume reduction

Intervention Type: PROCEDURE

Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment

Interventions

Bronchoscopic Lung volume reduction

Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bakeer

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad Saad El-Morsi, Prof

Role: STUDY_CHAIR

Chest Medicine Department, Faculty of Medicine, Mansoura University

Locations

Chest Medicine Department, Faculty Of Medicine, Mansoura University

Al Mansurah, Al-dakahliya, Egypt

Countries

Egypt

Other Identifiers

MD68

Identifier Type: -

Identifier Source: org_study_id