Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 主要终点
- number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
研究概览
简要总结
Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our disappointment, pulmonary and critical care medicine have traditionally lagged behind other therapeutic and research fields including hematology, gastroenterology and cardiology in translational studies of the use of reparative cells
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years (both inclusive)
- •high-resolution computed tomography (HRCT) scan that is very suggestive or consistent with a probable diagnosis of usual interstitial pneumonia.
- •Bronchoalveolar lavage must be performed at any time before inclusion and must have failed to show features supporting alternative diagnoses.
- •The duration of the disease should be more than three months, and bibasilar inspiratory crackles should be present.
- •dyspnea score of at least 2 on a scale of 0 (minimum) to 10 (maximum).
- •FVC > 50% of the predicted normal value and DLco > 35% of the predicted value.
- •Patients under treatment with n-acetylcysteine or pirfenidone should discontinue drug and enter a wash-out period for at least 6 weeks prior study enrolment.
排除标准
- •FVC < 50% predicted normal value and DLCO < 35%predicted normal value.
- •lung cancer or with an evidence of active malignancyfor at least 5 years.
- •uncontrolled heart failure.
- •renal failure
- •hepatic failure,
- •neurological abnormalities including stroke and myasthenia Gravis
- •Anti-coagulants therapy.
- •Active infections.
结局指标
主要结局
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
时间窗: 6 months
safety and side effects
次要结局
- Post therapy diffusing capacity of CO% (DLCO)predicted(6-12 months)
- post therapy forced vital capacity (FVC)% predicted.(6-12 months)
研究者
Aliae AR Mohamed Hussein
Prof. Dr. Aliae AR Mohamed-Hussein, Professor of Pulmonology
Assiut University