Allogeneic Human Umbilical Cord-derived Mesenchymal Stem/Stromal Cells for Chronic Obstructive Pulmonary Disease (COPD): Study Protocol for a Matched Case-control, Phase I/II Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events
研究概览
简要总结
This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines
详细描述
The aim of this trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines. This matched case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between June 2020 and December 2021. In this study, 40 patients will be enrolled and assigned into two age-, gender- and COPD condition-matched groups, including a UC-MSC group and a control group. Both groups will receive standard COPD medication treatment based on the GOLD 2019 guidelines and the Vietnam Ministry of Health protocol. The UC-MSC group will receive two doses of thawed UC-MSC product with an intervention interval of 3 months. The primary outcome measures will include the incidence of prespecified administrationassociated adverse events (AEs) and serious adverse events (SAEs). The efficacy will be evaluated based on the absolute changes in the number of admissions, arterial blood gas analysis, lung function and lung fibrosis via CT scan and chest X-ray. The clinical evaluation will be conducted at baseline and 3, 6, and 12 months post
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with COPD with stage B, C, or D according to GOLD
- •Age between 40-75 years old.
- •Both genders.
排除标准
- •Smoker or less than 6 months of smoking cessation time.
- •Asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer).
- •Acute and/or active infection.
- •Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
- •Liver and kidney failure.
- •Pregnancy.
- •Patients with life expectancy less than 6 months due to concomitant illness.
- •Under immunosuppressive treatment within 8 weeks of the first screening visit.
- •Patient diagnosed diabetes with HbA1C>7%
研究组 & 干预措施
control arm
drug therapy according to Vietnamese MOHS procedure
干预措施: drug therapy according to Vietnamese MOHS procedure (Drug)
Treatment (UC-MSC trasnplatation)
1 x 10^6 umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with Vietnames MOH procedure
干预措施: Umbilical Cord Mesenchymal Stem Cells transplantation (Biological)
Treatment (UC-MSC trasnplatation)
1 x 10^6 umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with Vietnames MOH procedure
干预措施: drug therapy according to Vietnamese MOHS procedure (Drug)
结局指标
主要结局
Adverse events and serious adverse events
时间窗: up to the 12-month period following treatment
To assess safety, the number of AEs or SAEs during stem cell administration (72 h) at 3 months, 6 months, and 12 months after discharge will be evaluated
次要结局
- Respiratory functions (FEV1/FVC)(up to the 12-month period following treatment)
- Respiratory functions (VC)(up to the 12-month period following treatment)
- inflammatory response (Pro-BNP)(up to the 12-month period following treatment)
- cytokine analysis from patients' plasma(up to the 12-month period following treatment)
- Quality of Life using Georges Respiratory Questionnaire(up to the 12-month period following treatment)
- inflammatory response (CRP)(up to the 12-month period following treatment)
- arterial blood gas analysis (pH)(up to the 12-month period following treatment)
- Respiratory functions (FEV1)(up to the 12-month period following treatment)
- Respiratory functions (TLC)(up to the 12-month period following treatment)
- Respiratory functions (DLCO)(up to the 12-month period following treatment)
- inflammatory response (Troponin-T)(up to the 12-month period following treatment)
- Chest CT(up to the 12-month period following treatment)
- arterial blood gas analysis (PaO2)(up to the 12-month period following treatment)
- arterial blood gas analysis (PaCO2)(up to the 12-month period following treatment)
- arterial blood gas analysis (BE)(up to the 12-month period following treatment)
- arterial blood gas analysis (HCO3-)(up to the 12-month period following treatment)
- Respiratory functions (RV)(up to the 12-month period following treatment)
- Respiratory functions (DLNO/DLCO)(up to the 12-month period following treatment)
- modified medical research council(up to the 12-month period following treatment)