A feasibility and safety study of bronchoscopic intrabullous autologous blood instillation for the treatment of severe bullous emphysema.

Patients with end-stage COPD suffer from severe dyspnea and a poor quality of
life, with no current effective medical treatment. Only for a very small,
highly selective group of COPD patients, very invasive surgical procedures like
lung volume reduction surgery (LVRS) or lung transplantation are available.
Furthermore for patients with severe bullous emphysema, removal of giant bullae
(bullectomy) has been a standard treatment in selected patients for many years.
Unfortunately, bullectomy is major surgery and requires general anesthesia, a
prolonged hospital stay, and is associated with a significant risk of
complications.
Less invasive and safer approaches to try and shrink the size of bulla(e)
without surgery are needed, and some early work has suggested that similar
results to bullectomy can be achieved by injecting the patient*s own blood
directly into the bulla(e) by bronchoscope. The blood starts an inflammatory
reaction which ultimately leads to the formation of scar tissue and shrinking
of the treated area. Also, as the clotted blood and inflammatory tissue filling
the bulla is slowly absorbed by the body, the walls of the bulla are pulled
inwards further shrinking its size. This works to allow expansion of the more
healthy lung. If effective, intrabullous autologous blood injection into large
bullae can be a readily available, minimally invasive and cheap way of treating
large bullae in a group of patients with end-stage disease who have limited
treatment options. Currently, 12 patients in Japan and 11 patients in the
United Kingdom were treated with this new technique and these studies showed
encouraging results, without any serious complications. The encouraging results
with using this technique in this patient group and the safety of the procedure
has encouraged us to undertake a formal feasibility study to investigate the
effectiveness and safety of intrabullous blood instillation.

To assess the safety and effects of bronchoscopic intrabullous blood
instillation in patients with bullous emphysema on lung function, quality of
life measures, functional measures and CT measured lung volumes.

Prospective open label single arm study.

Bronchscopic instillation of autologous blood in the bulla.

This study is designed to assess the feasibility and safety of bronchoscopic
intrabullous autologous blood instillation for the treatment of severe bullous
emphysema. Patients with bullous emphysema will be included who have no other
medical treatment, surgical or other experimental bronchoscopic intervention
treatment options. It is possible that a patient will not receive any benefits
from the treatment. The pilot studies showed promising results on the safety
and effects of the procedure. Furthermore, other studies using experimental
bronchoscopic techniques have shown that it is a safe procedure in patients
with severe emphysema. The use of autologous blood does not include using
foreign implants and is therefore much cheaper. We hope that the procedure will
result in the majority of patients in a clinical and statistically significant
increase in FEV1 and FVC, with decreasing RV, resulting in a significant
reduction in dyspnea and improvement in quality of life as measured with the
SGRQ, and a better exercise tolerance as measured with the 6MWT.