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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Masih Daneshvari Hospital
Sponsor:
Collaborator:
Royan Institute
Information provided by (Responsible Party):
Arda Kiani, Masih Daneshvari Hospital
ClinicalTrials.gov Identifier:
NCT01758055
First received: November 18, 2012
Last updated: December 23, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Emphysema
Biological: Autologous MSCs transplantation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema

Resource links provided by NLM:


Further study details as provided by Masih Daneshvari Hospital:

Primary Outcome Measures:
  • forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC [ Time Frame: Baseline and one year after procedure ] [ Designated as safety issue: Yes ]
    • 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:
  • six minute walk test [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]
    •A six minute walk test with treadmills


Other Outcome Measures:
  • oxygen saturation [ Time Frame: Baseline and one year after procedure ] [ Designated as safety issue: Yes ]
    •An oximeter test for evaluating the oxygen saturation

  • Quality of life [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]
    •A SF36 quality of life questioner for evaluating the quality of life

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

  • CT scan [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]
    •A CT scan for evaluating the changes

  • dyspnea score [ Time Frame: Baseline and One year after procedure ] [ Designated as safety issue: Yes ]
    •A MMRC(modified medical research council) scale for evaluating the dyspnea score

  • 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 ] [ Designated as safety issue: Yes ]
    • presence of oxygen in blood gases
    • presence of carbon dioxide in blood gases

  • Infection [ Time Frame: Baseline and one year after procedure ] [ Designated as safety issue: Yes ]
    •A CBC test for evaluating the infection


Estimated Enrollment: 12
Study Start Date: December 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Autologous MSCs transplantation

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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758055

Contacts
Contact: Arda Kiani, MD,PULMONO 0098-021-27122171 Kiani@nritld.ac.ir
Contact: Naser Aghdami, MD, PHD 0098-021-22172330 nasser.aghdami@royaninstitute.org

Locations
Iran, Islamic Republic of
Masih-Daneshvari Hospital Not yet recruiting
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
Investigators
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
  More Information

No publications provided

Responsible Party: Arda Kiani, Professor of Shahid Beheshti University, Masih Daneshvari Hospital
ClinicalTrials.gov Identifier: NCT01758055     History of Changes
Other Study ID Numbers: f-91-135
Study First Received: November 18, 2012
Last Updated: December 23, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Masih Daneshvari Hospital:
Mesenchymal stem cell, emphysema, lung function

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014