Bone-marrow Derived Mesenchymal Stromal Cells Associated With One-way Endobronchial Valves in Patients With Pulmonary Emphysema: Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Absence of lung deficits during the procedure and/or in the 4 months follow-up
研究概览
简要总结
The combined use of one-way endobronchial valves and bone-marrow derived mesenchymal stromal cells in patients with severe pulmonary emphysema is safe and will contribute to increase quality of life.
详细描述
In addition to testing the safety of one-way endobronchial valves combined with bone-marrow derived mesenchymal stromal cells, the study will determine the systemic inflammatory potential of cell therapy measured by C-reactive protein levels (CRP), erythrocyte sedimentation rate (ESR) and complete blood count in peripheral blood. Finally, the study will aim at determining if other markers of inflammatory response and remodeling are modulated by this therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of severe heterogeneous emphysema (heterogeneity > 15%), with heterogeneity defined as the difference between lobes in the percent area covered by parenchymal density greater than -950 Hounsfield Units.
- •Estimation of collateral ventilation based on fissure with integrity ≥ 75%.
- •Total lung capacity> 100% predicted.
- •Residual volume> 150% predicted.
- •Forced expiratory volume at the first minute <45% predicted.
- •Diffusing capacity of the lungs for carbon monoxide <45% predicted.
- •Optimal medical treatment.
- •Limitations in daily physical activities.
- •Minimum of 4 months without smoking
- •Having family support.
- •Stage ≥ 2 in modified Medical Research Council Dyspnea Scale (MMRC).
排除标准
- •Homogenous emphysema.
- •Presence of collateral ventilation.
- •Use of systemic corticosteroids (prednisone> 20mg/day or equivalent).
- •Pulmonary or extrapulmonary infection.
- •Coronary heart disease and/or severe ventricular dysfunction.
- •Significant renal or liver disease.
- •Immunosuppressive disease.
- •Active smoking.
- •Cancer prognosis with survival <2 years.
- •Psychosocial problems.
- •Pregnancy.
研究组 & 干预措施
Valves plus cells
Bronchoscopy Five patients will be selected to receive bone-marrow derived mesenchymal stromal cells delivered bronchoscopically right before insertion of one-way endobronchial valves.
干预措施: Bronchoscopy (Procedure)
Valves plus saline
Bronchoscopy Five patients will be selected for treatment with one-way endobronchial valves only, with saline injected prior to valve insertion.
干预措施: Bronchoscopy (Procedure)
结局指标
主要结局
Absence of lung deficits during the procedure and/or in the 4 months follow-up
时间窗: 4 months
次要结局
- Quality of Life(120 days)
- Pulmonary function(120 days)
- Inflammation(120 days)
研究者
Hugo Goulart de Oliveira
Associate Professor
Hospital de Clinicas de Porto Alegre