Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients
The purpose of this study is evaluating the safety of endobronchial transplantation of autologous mesenchymal stem cells derived bone marrow in patients with emphysema.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema|
- forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC [ Time Frame: Baseline and one year after procedure ] [ Designated as safety issue: Yes ]
- 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.
- six minute walk test [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]•A six minute walk test with treadmills
- oxygen saturation [ Time Frame: Baseline and one year after procedure ] [ Designated as safety issue: Yes ]•An oximeter test for evaluating the oxygen saturation
- Quality of life [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]•A SF36 quality of life questioner for evaluating the quality of life
- DLCO(diffusion capacity of lung for carbon monoxide) [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]•Body Box device for evaluating diffusing capacity of the lung for carbon monoxide
- CT scan [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]•A CT scan for evaluating the changes
- dyspnea score [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]•A MMRC(modified medical research council) scale for evaluating the dyspnea score
- Atrial blood gases test-PaO2(partial pressure of oxygen in blood) , PaCO2(partial pressure of carbon dioxide in blood) [ Time Frame: Baseline and one year after procedure ] [ Designated as safety issue: Yes ]
- presence of oxygen in blood gases
- presence of carbon dioxide in blood gases
- Infection [ Time Frame: Baseline and one year after procedure ] [ Designated as safety issue: Yes ]•A CBC test for evaluating the infection
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: Autologous MSCs transplantation
intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once
Biological: Autologous MSCs transplantation
Autologous mesenchymal stem cells derived bone marrow, bronchoscopy
Other Name: Autologous MSCs transplantation
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 assess according to SF-36(Medical Outcomes Study 36-Items Short-Form Health Survey) questioner.
Patients will taken to the operating room, placed in a prone position, and administer a spinal anesthesia. Approximately, 120 mL of bone marrow will aspirated from each puncture and after preparation about 60 million autologous MSCs will transplant by bronchoscopy into the endobronchial of these patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758055
|Contact: Arda Kiani, MD,PULMONO||0098-021-27122171||Kiani@nritld.ac.ir|
|Contact: Naser Aghdami, MD, PHDfirstname.lastname@example.org|
|Iran, Islamic Republic of|
|Masih-Daneshvari Hospital||Not yet recruiting|
|Tehran, Iran, Islamic Republic of, 021|
|Contact: ARDA KIANI, MD,PULMONO 0098-021-27122171 KIANI@NRITLD.AC.IR|
|Contact: PARITASH TAHMASEB POUR, MD 0098-09125037861 PARITASH_T@YAHOO.COM|
|Principal Investigator: Paritash Tahmaseb pour, MD|
|Principal Investigator: Hoda Madani, MD|
|Study Director:||Arda Kiani, MD, pulmono||Tracheal Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.|
|Study Director:||Naser Aghdami, MD,PHD||Department of Regenerative Biomedicine and cell therapy,Cell science Research Center,Royan Institute for Stem Cell Biology and Technology,ACER,Tehran,Iran|