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

Phase 1

• Conditions: Emphysema
• Interventions: Biological: Autologous MSCs transplantation

• Registration Number: NCT01758055
• Lead Sponsor: Arda Kiani

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 Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-18
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-23
• Last Update Submitted: 2012-12-23
• Study First Posted: 2012-12-31
• Last Update Posted: 2012-12-31
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous MSCs transplantation	Autologous MSCs transplantation	intra bronchial injection, Autologous MSCs transplantation derived bone marrow, 60millions cells, once

Primary Outcome Measures

Name	Time	Method
forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC	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.

Secondary Outcome Measures

Name	Time	Method
six minute walk test	Baseline and One year after procedure	•A six minute walk test with treadmills

Trial Locations

Locations (1)

Masih-Daneshvari Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of