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

Emphysema Clinical Trial

Official title:

Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells Derived Bone Marrow in Patients With Emphysema

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01758055
• Other study ID #: f-91-135
• Status: Not yet recruiting
• Phase: Phase 1
• First received: November 18, 2012
• Last updated: December 23, 2012
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: November 2012
• Source: Masih Daneshvari Hospital
• Contact: Arda Kiani, MD,PULMONO
• Phone: 0098-021-27122171
• Email: Kiani[@]nritld.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Biological:
• Autologous MSCs transplantation
Autologous mesenchymal stem cells derived bone marrow, bronchoscopy

Locations

Country	Name	City	State
Iran, Islamic Republic of	Masih-Daneshvari Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Arda Kiani	Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	oxygen saturation	•An oximeter test for evaluating the oxygen saturation	Baseline and one year after procedure	Yes
Other	Quality of life	•A SF36 quality of life questioner for evaluating the quality of life	Baseline and One year after procedure	Yes
Other	DLCO(diffusion capacity of lung for carbon monoxide)	•Body Box device for evaluating diffusing capacity of the lung for carbon monoxide	Baseline and One year after procedure	Yes
Other	CT scan	•A CT scan for evaluating the changes	Baseline and One year after procedure	Yes
Other	dyspnea score	•A MMRC(modified medical research council) scale for evaluating the dyspnea score	Baseline and One year after procedure	Yes
Other	Atrial blood gases test-PaO2(partial pressure of oxygen in blood) , PaCO2(partial pressure of carbon dioxide in blood)	presence of oxygen in blood gases; presence of carbon dioxide in blood gases	Baseline and one year after procedure	Yes
Other	Infection	•A CBC test for evaluating the infection	Baseline and one year after procedure	Yes
Primary	forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC	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.	Baseline and one year after procedure	Yes
Secondary	six minute walk test	•A six minute walk test with treadmills	Baseline and One year after procedure	Yes