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临床试验/NCT01758055
NCT01758055Unknown1 期

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

Arda Kiani2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年12月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
12
试验地点
2
主要终点
forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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

排除标准

  • 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

结局指标

主要结局

forced vital capacity( FVC), forced expiratory volume(FEV1), FEV1/FVC

时间窗: 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.

次要结局

  • six minute walk test(Baseline and One year after procedure)

研究者

发起方
Arda Kiani
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Arda Kiani

Professor of Shahid Beheshti University

Masih Daneshvari Hospital

研究点 (2)

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