Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Royan Institute | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is evaluating the safety of endobronchial transplantation of autologous mesenchymal stem cells derived bone marrow in patients with emphysema.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous MSCs transplantation | Experimental | intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous MSCs transplantation | Biological | Autologous mesenchymal stem cells derived bone marrow, bronchoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC |
| Baseline and one year after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| six minute walk test | •A six minute walk test with treadmills | Baseline and One year after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| oxygen saturation | •An oximeter test for evaluating the oxygen saturation | Baseline and one year after procedure |
| Quality of life | •A SF36 quality of life questioner for evaluating the quality of life |
Inclusion Criteria:
• Inclusion criteria were as follows:
Exclusion Criteria:
Exclusion criteria were as follows:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arda Kiani, MD,PULMONO | Contact | 0098-021-27122171 | Kiani@nritld.ac.ir | |
| Naser Aghdami, MD, PHD | Contact | 0098-021-22172330 | nasser.aghdami@royaninstitute.org |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masih-Daneshvari Hospital | Tehran | Tehran Province | 021 | Iran |
Not provided
| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and One year after procedure |
| DLCO(diffusion capacity of lung for carbon monoxide) | •Body Box device for evaluating diffusing capacity of the lung for carbon monoxide | Baseline and One year after procedure |
| CT scan | •A CT scan for evaluating the changes | Baseline and One year after procedure |
| dyspnea score | •A MMRC(modified medical research council) scale for evaluating the dyspnea score | Baseline and One year after procedure |
| Atrial blood gases test-PaO2(partial pressure of oxygen in blood) , PaCO2(partial pressure of carbon dioxide in blood) |
| Baseline and one year after procedure |
| Infection | •A CBC test for evaluating the infection | Baseline and one year after procedure |
| Study Director |