The aim of research: Changes in morphological structure of airway system are associated with chronic obstructive pulmonary deficiency following exposure to sulfur mustard gas. With extensive progress and achievements in tissue repairing through stem cells therapy, considering of lung tissue has been increased due to the high prevalence of pulmonary problems. Several factors such as selection of cell types, necessary conditions for growth and proliferation of stem cells, and the process of entering into the body to repair of damaged lung tissue are considered as the most important problems in this issue. Use of mesenchymal stem cells (MSC) in animals and human clinical trials supported the hypothesis of therapeutic effects of these cells in various disorders. The aim of this study is to evaluate MSC safety and perform an initial evaluation of the potential efficacy of systemic MSC administration to sulfur mustard patients with chronic lung injuries.
Methods: Ten patients will receive 100 million cells per each infusion for two months and then they will be followed for 6 month after the first infusion. Finally, patients will be considered in case of safety of treatment, pulmonary function testing (PFT), quality-of-life indicators, 6MWT, and expression of inflammation and oxidative stress genes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110524890N1
Registration date:2015-11-25, 1394/09/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
Amir nejad-moghaddam
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2000
Email address
an-moghaddam@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Veterans Foundation
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of autologous adipose mesenchymal stem cells in treatment of airway injury in patients exposed to sulfur mustard
Public title
Use of stem cells in treatment of lung injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who had a documentary exposure to mustard gas in the Iran-Iraq war; their disease severity were as following based on spirometric: moderate 50<FEV1<65 or severe 40<FEV1<50; absence of contraindications spirometry (recent MI ،hemoptysis, cerebral arterial aneurysm or aortic, pulmonary embolism, uncontrolled blood pressure, recent pneumothorax, no doubt surgery/recent thoracic, recent eye surgery, recent stroke); non-availability in another research study at a same time; no coagulation disorders; exclusion criteria: smoking; the incidence of pneumonia during the study; the incidence of transfusion reaction; other medical condition (cardiovascular disease, hypertension, diabetes); visiting less than 2 times.
Age
From 54 years old to 34 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences
City
Tehran
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
IR.BMSU.REC.1393.32
Health conditions studied
1
Description of health condition studied
Airway damage in chemical injuries
ICD-10 code
J68.4
ICD-10 code description
Chronic respiratory conditions due to chemicals, gases, fumes and vapours
Primary outcomes
1
Description
Improvement in breathing and respiratory capacity
Timepoint
2 month
Method of measurement
spirometry test, kit, molecular assay
Secondary outcomes
1
Description
Treatment of damaged airway
Timepoint
1 years
Method of measurement
spirometry test and kit
Intervention groups
1
Description
Patients will receive 100 millions cells during 4 injections for a period of two month.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Amir Nejadmoghaddam
Street address
Baqiyatallah Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Veterans Foundation
Full name of responsible person
Dr Sedighi Moghaddam
Street address
Taleghani Street, between Hafez and Vali-Asr
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?