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

NCT02749448 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-07-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Dr. Mostafa Ghanei

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-11-30
Completion
2017-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02749448 on ClinicalTrials.gov