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Background: Sulfur mustard (SM) is a potent alkylating agent that targets several organs, especially lung tissue. SM exposure leads to serious changes in morphological structure of airway system, which is associated with chronic obstructive pulmonary deficiency following exposure to SM. With extensive progress and achievements in tissue repair through stem cells therapy, consideration of lung tissue has been increased due to the high prevalence of pulmonary problems. Several factors such as selection of cell types, required conditions for growth and proliferation of stem cells, and the process of entering into the body to repair damaged lung tissue are considered as the most important problems in this issue. Accumulating studies, both in animals and human with mesenchymal stem cells (MSC) support the hypothesis of therapeutic effects of these cells in various disorders. In this study investigators aimed to evaluate safety and potential efficacy of systemic MSC administration for treatment of chronic lung injuries in SM-exposed patients.
Methods: Patients will receive 100 million MSC cells every two months for three injections within 6 months. After each injection, parameters including safety, pulmonary function testing (PFT), quality-of-life indicators, 6 minute walk test (6MWT), and expression of inflammation and oxidative stress genes will be evaluated.
Patients selection:
In this clinical trial, investigators considered therapeutic effect of MSCs in SM-exposed male patients.Patients, had a documented encounter with SM during the Iran-Iraq war. The patients signed informed consent before study. They were selected according to the following criteria: (a) the severity of lung injury was ranged from moderate 50< forced expiratory volume in 1 second (FEV1) <65 to severe 40\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenchymal stem cell | Other | There are complex sets of non-hematopoietic cells in bone marrow called mesenchymal progenitor cells (MPCs). MSCs are well-known as multipotent cells that have the ability to self-renew and differentiate into a great variety of cells. MSCs can be isolated from bone marrow, umbilical cord, peripheral blood and adipose tissue, and cultured in specific media. MSC colony formation, which is known as marrow-like stromal cells and MPCs, is similar to fibroblast colony forming unit (CFU-F) in in vitro condition. According to the International Society for Cellular Therapy (ISCT), MSCs can be easily detected or identified from other cells using flow cytometric analysis to detect specific surface markers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesenchymal stem cell | Other | There are complex sets of non-hematopoietic cells in bone marrow called mesenchymal progenitor cells (MPCs). MSCs are well-known as multipotent cells that have the ability to self-renew and differentiate into a great variety of cells. MSCs can be isolated from bone marrow, umbilical cord, peripheral blood and adipose tissue, and cultured in specific media. MSC colony formation, which is known as marrow-like stromal cells and MPCs, is similar to fibroblast colony forming unit (CFU-F) in in vitro condition. According to the International Society for Cellular Therapy (ISCT), MSCs can be easily detected or identified from other cells using flow cytometric analysis to detect specific surface markers |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary function testing (PFT) | Pulmonary Function Testing (PFT) is a complete evaluation of the respiratory system including patient history, physical examinations, chest x-ray examinations, arterial blood gas analysis, and tests of pulmonary function. The primary purpose of pulmonary function testing is to identify the severity of pulmonary impairment. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) | The SGRQ is designed to measure health impairment in patients with asthma and COPD. It is also valid for use in bronchiectasis and has been used successfully in SM patients | one year |
| 6 minute walk test (6MWT) |
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Inclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32935623 | Derived | Marzouni ET, Dorcheh SP, Nejad-Moghaddam A, Ghanei M, Goodarzi H, Hosseini SE, Madani H. Adipose-derived mesenchymal stem cells ameliorate lung epithelial injury through mitigating of oxidative stress in mustard lung. Regen Med. 2020 Sep 16. doi: 10.2217/rme-2020-0051. Online ahead of print. |
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there is no individual participant data
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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The original purpose of the six minute walk was to test exercise tolerance in chronic respiratory disease and heart failure. |
| one year |