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Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01758055
Recruitment Status : Unknown
Verified November 2012 by Arda Kiani, Masih Daneshvari Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Royan Institute
Information provided by (Responsible Party):
Arda Kiani, Masih Daneshvari Hospital

Brief Summary:
The purpose of this study is evaluating the safety of endobronchial transplantation of autologous mesenchymal stem cells derived bone marrow in patients with emphysema.

Condition or disease Intervention/treatment Phase
Emphysema Biological: Autologous MSCs transplantation Phase 1

Detailed Description:

Chronic obstructive pulmonary disease (COPD) is a worldwide epidemic disease that the global prevalence of it was estimated to be approximately 210 million individuals and accounting for more than three million deaths annually. And currently, it is the fifth chief cause of death in the United State of America. COPD is characterized by chronic, irreversible inflammation of the airways and has two pathologic features, emphysema and bronchiolitis.

The most relevant feature in the lung emphysema is airflow limitation, resulting from the loss of alveolar wall and enlargement of alveolar space distal to the terminal bronchiole. Cigarette and air pollution are the most major factors for developing COPD. Unfortunately, aside from supplemental domiciliary oxygen for the small number of patients who demonstrate resting arterial hypoxemia and smoking cessation for continued smokers, there are no interventions that have been unequivocally shown to prolong survival in patients with COPD. In the preprocessing phase, patients will underwent a complete evaluation of the pulmonary function test with spirometer to measure the FEV1, FVC, FEV1/FVC, cardiac evaluation (clinical examination, six minute walk test, echocardiography TTE(transthoracic echocardiography ), and electrocardiography),chest X-ray, chest computed tomography scan (helical/high resolution),o2 saturation by oximeter, as well as routine laboratory tests (blood gas, urinalysis, coagulation, complete blood count (CBC), blood urea nitrogen, fasting glucose, creatinine, AST(aspartate aminotransferase), ALT(alanine aminotransferase), C-reactive protein, serology for hepatitis B and C, antihuman immunodeficiency virus, and treponemal test for syphilis (FTA-ABS)). The Dyspnea Scale Score test, modified according to the British MMRC, was also conducted, according to Mahler and Wells and Curley.And quality of life measures will assess according to SF-36(Medical Outcomes Study 36-Items Short-Form Health Survey) questioner.

Patients will taken to the operating room, placed in a prone position, and administer a spinal anesthesia. Approximately, 120 mL of bone marrow will aspirated from each puncture and after preparation about 60 million autologous MSCs will transplant by bronchoscopy into the endobronchial of these patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: Autologous MSCs transplantation
intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once
Biological: Autologous MSCs transplantation
Autologous mesenchymal stem cells derived bone marrow, bronchoscopy

Primary Outcome Measures :
  1. forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC [ Time Frame: Baseline and one year after procedure ]
    • A pulmonary function test that measures the volume and speed of inhaled air.
    • A pulmonary function test that measures the volume and speed of exhaled air.

Secondary Outcome Measures :
  1. six minute walk test [ Time Frame: Baseline and One year after procedure ]
    •A six minute walk test with treadmills

Other Outcome Measures:
  1. oxygen saturation [ Time Frame: Baseline and one year after procedure ]
    •An oximeter test for evaluating the oxygen saturation

  2. Quality of life [ Time Frame: Baseline and One year after procedure ]
    •A SF36 quality of life questioner for evaluating the quality of life

  3. DLCO(diffusion capacity of lung for carbon monoxide) [ Time Frame: Baseline and One year after procedure ]
    •Body Box device for evaluating diffusing capacity of the lung for carbon monoxide

  4. CT scan [ Time Frame: Baseline and One year after procedure ]
    •A CT scan for evaluating the changes

  5. dyspnea score [ Time Frame: Baseline and One year after procedure ]
    •A MMRC(modified medical research council) scale for evaluating the dyspnea score

  6. Atrial blood gases test-PaO2(partial pressure of oxygen in blood) , PaCO2(partial pressure of carbon dioxide in blood) [ Time Frame: Baseline and one year after procedure ]
    • presence of oxygen in blood gases
    • presence of carbon dioxide in blood gases

  7. Infection [ Time Frame: Baseline and one year after procedure ]
    •A CBC test for evaluating the infection

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • • Inclusion criteria were as follows:

    • patients with moderate to severe emphysema that has a FEV1≤50% (approved by HRCT)
    • aged less than 70 years
    • no tobacco use for at least 12 months before the protocol application
    • no serious coronaropathy and/or ventricular dysfunction
    • no significant renal illness and/or hepatitis
    • EF(ejection fraction)>50%
    • Creatinine < 2
    • AST, ALT≤ 10 times of its normal basis

Exclusion Criteria:

  • Exclusion criteria were as follows:

    • detected immunosuppressive illnesses
    • carrier of known neoplasias
    • pregnancy
    • limitation in daily physical activities
    • known case of diabetic disorders
    • modifying in his/her medical treatment regime in the past year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01758055

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Contact: Arda Kiani, MD,PULMONO 0098-021-27122171
Contact: Naser Aghdami, MD, PHD 0098-021-22172330

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Iran, Islamic Republic of
Masih-Daneshvari Hospital
Tehran, Iran, Islamic Republic of, 021
Contact: ARDA KIANI, MD,PULMONO    0098-021-27122171    KIANI@NRITLD.AC.IR   
Contact: PARITASH TAHMASEB POUR, MD    0098-09125037861    PARITASH_T@YAHOO.COM   
Principal Investigator: Paritash Tahmaseb pour, MD         
Principal Investigator: Hoda Madani, MD         
Sponsors and Collaborators
Arda Kiani
Royan Institute
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Study Director: Arda Kiani, MD, pulmono Tracheal Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Study Director: Naser Aghdami, MD,PHD Department of Regenerative Biomedicine and cell therapy,Cell science Research Center,Royan Institute for Stem Cell Biology and Technology,ACER,Tehran,Iran

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Responsible Party: Arda Kiani, Professor of Shahid Beheshti University, Masih Daneshvari Hospital Identifier: NCT01758055    
Other Study ID Numbers: f-91-135
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: November 2012
Keywords provided by Arda Kiani, Masih Daneshvari Hospital:
Mesenchymal stem cell, emphysema, lung function
Additional relevant MeSH terms:
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Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases