Clinical Trial: Safety and Feasibility Study of Administration of Mesenchymal Stemcells for Treatment of Emphysema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Autologous Bone Marrow Derived Mesenchymal Stromal Cells Prior to Lung Volume Reduction Surgery for Severe Pulmonary Emphysema- a Phase I Safety and Feasibility

Brief Summary: The purpose of this study is to show safety and feasibility to administer patients own mesenchymal stem cells to show signs of repair of emphysematous lung tissue

Detailed Summary:

Study Rationale Emphysema is one of the two main components of chronic obstructive pulmonary disease (COPD) and contributes over many years to airway obstruction by the loss of elastic recoil around the smallest airways. Emphysema is induced by cigarette smoking and it is widely accepted that the disease is caused by excessive proteolytic activity by proteases and a chronic inflammatory process, characterized by a cellular influx consisting of macrophages, neutrophils and T cells. This inflammatory response is steroid resistant and leads to slow but persistent alveolar destruction, resulting in enlarged lungs with bullous parts in both lungs. In addition to a central role of innate immunity, recent studies suggest that also (auto)antigen specific immunity may play a role in the pathogenesis of COPD.

Currently, the only treatment available for severe emphysema is lung volume reduction surgery (LVRS) to remove the most destroyed parts of the lungs. The surgery is generally performed in two separate sessions with a 10-12 weeks interval, with each lung as a separate surgical target. This surgical treatment allows improved ventilation in the remaining less affected areas of the lungs as demonstrated by post-surgical clinical improvement of lung function and increased survival in a subgroup of patients. Delayed wound healing after LVRS is an important clinical problem. It may lead to prolonged hospital stay due to air leakage from the lungs into the thoracic cavity. Lung emphysema patients are at high risk for prolonged air leakage after this surgery, which is most likely explained by the inflammatory process related to the disease.

Mesenchymal stromal cells (MSC) are multipotent cells that can differentiate into several cell types, including fibroblasts, osteoblasts, adipocytes and chondrocyte progenitors. In recent years it ha
Sponsor: Leiden University Medical Center

Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Leiden University Medical Center

Dates:
Date Received: March 1, 2011
Date Started: October 2010
Date Completion:
Last Updated: November 16, 2012
Last Verified: November 2012