Clinical trial NCT01758055: Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients
Official title: Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Emphysema
Keywords: Mesenchymal stem cell, emphysema, lung function
Lead sponsor: Masih Daneshvari Hospital
Sponsor class: OTHER
Collaborators: name: Royan Institute
First posted: 2012-12-31
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC
timeFrame: Baseline and one year after procedure
Secondary outcomes:
measure: six minute walk test
timeFrame: Baseline and One year after procedure
Other outcomes:
measure: oxygen saturation
timeFrame: Baseline and one year after procedure
measure: Quality of life
timeFrame: Baseline and One year after procedure
measure: DLCO(diffusion capacity of lung for carbon monoxide)
timeFrame: Baseline and One year after procedure
measure: CT scan
timeFrame: Baseline and One year after procedure
measure: dyspnea score
timeFrame: Baseline and One year after procedure
measure: Atrial blood gases test-PaO2(partial pressure of oxygen in blood) , PaCO2(partial pressure of carbon dioxide in blood)
timeFrame: Baseline and one year after procedure
measure: Infection
timeFrame: Baseline and one year after procedure
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Masih-Daneshvari Hospital
Study officials:
affiliation: Tracheal Diseases Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
name: Arda Kiani, MD, pulmono
role: STUDY_DIRECTOR
affiliation: Department of Regenerative Biomedicine and cell therapy,Cell science Research Center,Royan Institute for Stem Cell Biology and Technology,ACER,Tehran,Iran
name: Naser Aghdami, MD,PHD
role: STUDY_DIRECTOR
References: