NCT02192736Unknown1 期
Safety and Feasibility Study of Intranasal Mesenchymal Trophic Factor (MTF) for Treatment of Asthma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
Allogeneic mesenchymal trophic factors (MTF) from human umbilical cord tissue-derived mesenchymal stem cells (UC-MSC) administered intra-nasally to 20 patients is a safe and useful procedure for inducing improvements in pulmonary function and quality of life in patients with asthma.
详细描述
The proposed study will assess primary safety and secondary efficacy endpoints of allogeneic UC-MSC-derived MTF administered to patients with asthma. Each patient will receive intra-nasal MTF once per week for a period of 4 weeks.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent form by the subject
- •Male or female
- •Between 18 and 65 years old and capability to comprehend this trial.
- •Asthma diagnosed by a physician at least 1 year prior to study enrollment
- •Poorly-controlled asthma at study enrollment. Poorly controlled asthma is defined as: chronic symptoms, episodic exacerbations, persistent and variable airways obstruction despite a continued requirement for short-acting beta 2-agonists despite the use of high doses of inhaled steroids.
- •Nonsmokers (stopped smoking at least 1 year ago) and limited life-time history of smoking (less than a 3 pack year history).
- •Body mass index 19-40
- •On a stable dose of inhaled corticosteroid for at least 4 weeks prior to study entry or had to use a rescue dose during the last 4 weeks.
- •FEV1 >50% predicted
排除标准
- •Pregnant or lactating women
- •Cognitively impaired adults
- •Systemic steroids within the 4 weeks prior to enrollment
- •Non-steroidal anti-inflammatory drugs (NSAIDs) for arthritis
- •Current diagnosis of polyposis or sinusitis.
- •Infection treated by antibiotics within the 4 weeks prior to enrollment
- •Immunization within the 4 weeks prior to enrollment
- •Lung pathology other than asthma
- •Other significant non-pulmonary co-morbidities such as: coronary artery disease, peripheral vascular disease, cerebrovascular disease, congestive heart failure with an ejection fraction <50%, liver disease or elevated liver enzymes at baseline, malignancy (excluding non-melanoma skin cancers), AIDS, renal failure with serum creatinine >3.0, or disorders requiring steroid treatment such as vasculitis, lupus, rheumatoid arthritis
- •Illicit drug use within the past year
- •Current/active upper respiratory infection (URI) (if active URI, wait until asymptomatic for 1 week to enroll)
- •Asthma exacerbation within the 4 weeks prior to enrollment (includes ER, urgent care, or hospital visits due to asthma resulting in an increase in asthma-related medications)
- •Undergoing evaluation for sleep apnea, or plans to institute treatment for sleep apnea (patients on a stable treatment regimen for sleep apnea for the last 3 months prior to enrollment will be allowed to participate)
- •Clinically significant abnormalities present on screening 12-lead electrocardiogram
- •Women of childbearing potential using oral contraceptives who are not willing to use a second method of contraception during the study
- •Participation in another clinical study within 4 weeks prior to enrollment
- •Subject does not sign informed consent
研究组 & 干预措施
Intra-nasal infusion of MTF
Other
Trophic factors from umbilical cord mesenchymal stem cells administered intra-nasally
干预措施: Trophic factors from umbilical cord mesenchymal stem cells (Biological)
结局指标
主要结局
Number of patients with adverse events
时间窗: 1 month
Evaluated 1 month after the final treatment
次要结局
- Number of patients with a change in pulmonary function from baseline as measured by Forced Expiratory Volume (FEV1) following American Thoracic Society (ATS) guidelines(a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month)
- Number of patients with a change in pulmonary function from baseline as measured by Forced Vital Capacity (FVC) following American Thoracic Society (ATS) guidelines(a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 monrh)
- Number of patients with a change in quality of life from baseline as measured by the University of Pittsburgh Medical Center (UPMC) Asthma Questionnaire(a) 1 week, 2 weeks, 3 weeks, 4 weeks b) 1 month)
研究者
研究点 (1)
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