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

NCT02749448 | Unknown Phase 1

• 1 other identifier: IRCT2015110524890N1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• St. George's Respiratory Questionnaire (SGRQ)

  one year

• 6 minute walk test (6MWT)

  one year

Study Arms (1)

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

Other: mesenchymal stem cell

Interventions

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

mesenchymal stem cell

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Mostafa Ghanei: lead

Related Publications (1)

• 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.

  PMID: 32935623 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: pulmonologist doctor

Study Record Dates

• First Submitted: April 9, 2016
• First Posted: April 25, 2016
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: February 1, 2017
• Last Updated: July 25, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share