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

Arda Kiani

Status and phase

Unknown

Phase 1

Conditions

Emphysema

Treatments

Biological: Autologous MSCs transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT01758055

f-91-135

Details and patient eligibility

About

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

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

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