A Phase I Open- Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Autologous Adipose Stem Cell (Adult Human) to Subjects With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Safety of adipose derived stem cells (ADSC) in Patient with COPD
研究概览
简要总结
The purpose of this study is: 1.- to assess the safety and tolerability of autologous adipose derived stem cells (aADSC) administered intravenously in patients with chronic obstructive pulmonary disease, and 2.- to assess if this therapy results in less decrease of lung function parameters (FEV1, FEV1/FVC and 6 min walking distance) compared with a control baseline of 6 weeks.
Patients will be followed up for 12 months after the therapy.
详细描述
STUDY DESIGN This is a Phase I open- label single-dose study in subjects with significant COPD. This is an expanded safety cohort. The investigators will enroll a minimum of 30 subjects. 6 week data of FEV1, FEV1/FVC, DLCO and 6 min walking distance values will be collected in all patients who are enrolled in the study (Baseline and 6 weeks after). Prior to the stem cell treatment, the patient will be assessed for 6 weeks by pulmonary function tests and 6 min walk tests. Then, patients will receive the infusion of stromal vascular fraction cells containing the aADSC (single intravenous dose). The standard therapy of COPD patients will not be interrupted during the duration of the study. Safety will be monitored on an ongoing basis, and an interim safety review will be conducted by the Investigator(s) and Sponsor after the first 20 patients have been enrolled and treated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females ≥18 years.
- •Cognitive competitiveness.
- •Diagnosis of at least moderate COPD (postbronchodilator FEV1/FVC < 70% (<0.7), FEV1 < 80% predicted).
- •Diffusing capacity impairment (DLCO) assessed by single breath test (corrected for alveolar volume, 'DLVA').
- •Life expectancy greater than 12 months.
- •Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf.
- •Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits.
- •No changes in active pulmonary medications for heart failure during the two weeks prior enrollment.
- •Written informed consent.
- •Non-smoker or Past smoker, with 20 pack-years or more history
排除标准
- •Current smokers.
- •Unstable coronary disease.
- •Patients with industrial exposure to silica and/or asbestos or giant bullae.
- •Uncontrolled seizure disorder.
- •Presence of immune deficiency or autoimmune disease.
- •Alpha- 1 antitrypsin deficiency.
- •Cor pulmonale or diastolic heart failure NYHA class III or IV
- •Type 1 diabetes mellitus
- •Complicated type 2 diabetes mellitus.
- •Active tuberculosis or severe lung damage due to tuberculosis (extensive cavitation).
- •History of cancer within the past 5 years.
- •Clinically-significant hematologic, hepatic, or renal impairment as determined by screening clinical laboratory tests.
- •Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment.
- •Allergy to sodium citrate or any "caine" type of local anesthetic.
- •Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury.
结局指标
主要结局
Safety of adipose derived stem cells (ADSC) in Patient with COPD
时间窗: 12 months
Safety/tolerability of Adipose Derived Stem Cell (ADSC) in patients with Chronic Obstructive Pulmonary Disease (COPD) during the twelve-month study period as determined by the incidence and severity of of adverse events.
次要结局
- Efficacy of ADSC In Pulmonary Function Test (PFTs)(2, 6, 12 months)
- Efficacy of adipose derived stem cell in 6 MWT(2, 6, 12 months)
- Efficacy in Quality of life using George's Respiratory Questionnaire(2, 6, 12 months)
- Efficacy in Quality of life using the Chronic Respiratory questionnaires(2, 6, 12 months)
- Efficacy of ADSC in improving Shortness of Breath (SOB)(2, 6 and 12 months)
- Efficacy of adipose derived stem cells in patient's perceived exertion.(2, 6, 12 months)