Clinical Trial: Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema

Brief Summary: The purpose of this study is evaluating the safety of endobronchial transplantation of autologous mesenchymal stem cells derived bone marrow in patients with emphysema.

Detailed Summary:

Chronic obstructive pulmonary disease (COPD) is a worldwide epidemic disease that the global prevalence of it was estimated to be approximately 210 million individuals and accounting for more than three million deaths annually. And currently, it is the fifth chief cause of death in the United State of America. COPD is characterized by chronic, irreversible inflammation of the airways and has two pathologic features, emphysema and bronchiolitis.

The most relevant feature in the lung emphysema is airflow limitation, resulting from the loss of alveolar wall and enlargement of alveolar space distal to the terminal bronchiole. Cigarette and air pollution are the most major factors for developing COPD. Unfortunately, aside from supplemental domiciliary oxygen for the small number of patients who demonstrate resting arterial hypoxemia and smoking cessation for continued smokers, there are no interventions that have been unequivocally shown to prolong survival in patients with COPD. In the preprocessing phase, patients will underwent a complete evaluation of the pulmonary function test with spirometer to measure the FEV1, FVC, FEV1/FVC, cardiac evaluation (clinical examination, six minute walk test, echocardiography TTE(transthoracic echocardiography ), and electrocardiography),chest X-ray, chest computed tomography scan (helical/high resolution),o2 saturation by oximeter, as well as routine laboratory tests (blood gas, urinalysis, coagulation, complete blood count (CBC), blood urea nitrogen, fasting glucose, creatinine, AST(aspartate aminotransferase), ALT(alanine aminotransferase), C-reactive protein, serology for hepatitis B and C, antihuman immunodeficiency virus, and treponemal test for syphilis (FTA-ABS)). The Dyspnea Scale Score test, modified according to the British MMRC, was also conducted, according to Mahler and Wells and Curley.And quality of life measures will asses
Sponsor: Arda Kiani

Current Primary Outcome: forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC [ Time Frame: Baseline and one year after procedure ]

  • A pulmonary function test that measures the volume and speed of inhaled air.
  • A pulmonary function test that measures the volume and speed of exhaled air.


Original Primary Outcome: Same as current

Current Secondary Outcome: six minute walk test [ Time Frame: Baseline and One year after procedure ]

•A six minute walk test with treadmills


Original Secondary Outcome: Same as current

Information By: Masih Daneshvari Hospital

Dates:
Date Received: November 18, 2012
Date Started: December 2012
Date Completion: January 2014
Last Updated: December 23, 2012
Last Verified: November 2012