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Mesenchymal Stem Cells Therapy for Treatment of Airway Remodeling in Mustard Patients

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ClinicalTrials.gov Identifier: NCT02749448
Recruitment Status : Unknown
Verified April 2016 by Dr. Mostafa Ghanei, Baqiyatallah Medical Sciences University.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Mostafa Ghanei, Baqiyatallah Medical Sciences University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease Other: mesenchymal stem cell Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Autologous Adipose Mesenchymal Stem Cells in Treatment of Airway Injury in Patients Exposed to Sulfur Mustard
Study Start Date : February 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
mesenchymal stem cell
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
Other: mesenchymal stem cell
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




Primary Outcome Measures :
  1. pulmonary function testing (PFT) [ Time Frame: one year ]
    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.


Secondary Outcome Measures :
  1. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: one year ]
    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

  2. 6 minute walk test (6MWT) [ Time Frame: one year ]
    The original purpose of the six minute walk was to test exercise tolerance in chronic respiratory disease and heart failure.



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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<forced expiratory volume at one second (FEV1)<65 or severe 40<FEV1<50
  • absence of contraindications spirometry (recent myocardial ischemia (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

Responsible Party: Dr. Mostafa Ghanei, pulmonologist doctor, Baqiyatallah Medical Sciences University
ClinicalTrials.gov Identifier: NCT02749448     History of Changes
Other Study ID Numbers: IRCT2015110524890N1
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: there is no individual participant data

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases