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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Royan Institute
Information provided by (Responsible Party):
Arda Kiani, Masih Daneshvari Hospital

Tracking Information
First Submitted Date  ICMJE November 18, 2012
First Posted Date  ICMJE December 31, 2012
Last Update Posted Date December 31, 2012
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2012)
six minute walk test [ Time Frame: Baseline and One year after procedure ]
•A six minute walk test with treadmills
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 23, 2012)
  • oxygen saturation [ Time Frame: Baseline and one year after procedure ]
    •An oximeter test for evaluating the oxygen saturation
  • Quality of life [ Time Frame: Baseline and One year after procedure ]
    •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 ]
    •Body Box device for evaluating diffusing capacity of the lung for carbon monoxide
  • CT scan [ Time Frame: Baseline and One year after procedure ]
    •A CT scan for evaluating the changes
  • dyspnea score [ Time Frame: Baseline and One year after procedure ]
    •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 ]
    • presence of oxygen in blood gases
    • presence of carbon dioxide in blood gases
  • Infection [ Time Frame: Baseline and one year after procedure ]
    •A CBC test for evaluating the infection
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients
Official Title  ICMJE Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Emphysema
Intervention  ICMJE Biological: Autologous MSCs transplantation
Autologous mesenchymal stem cells derived bone marrow, bronchoscopy
Study Arms  ICMJE Experimental: Autologous MSCs transplantation
intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once
Intervention: Biological: Autologous MSCs transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 23, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01758055
Other Study ID Numbers  ICMJE f-91-135
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arda Kiani, Masih Daneshvari Hospital
Study Sponsor  ICMJE Arda Kiani
Collaborators  ICMJE Royan Institute
Investigators  ICMJE
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
PRS Account Masih Daneshvari Hospital
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP