Efficacy and Safety of Normoxic Allogenic Umbilical Cord Mesenchymal Stem Cells Administered as Adjuntive Treatment to Standard Treatment in Severe Patients With COVID-19
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Duration of hospital stay
研究概览
简要总结
This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms
详细描述
This is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. The purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (UCMSC) in the treatment group, compared to the control group who are only given standard COVID-19 treatments and normal saline infusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman age 18-75 years
- •SARS-CoV2 positive as confirmed by SARS-CoV2 RT-PCR Test
- •Diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: RR > 30x per minute, SaO2 93%, FaO2/FiO2 300 mmHg
- •Voluntarily joined the clinical trial and has signed the informed consent form
排除标准
- •Pregnant and lactating woman
- •Patient who are diagnosed or have history of tumor and cancer
- •Patient whose mother or sister are diagnosed with breast or ovarian cancer
- •Level of SGPT/ALT is ≥ 5 times upper limit from normal value
- •Level of eGFR is < 30 ml/min
- •Reluctant to sign informed consent and unwilling to take the required tests
- •Require invasive ventilation
- •Organ failure
- •Currently involve in other clinical trial, or join another clinical trial in the last 3 months
结局指标
主要结局
Duration of hospital stay
时间窗: 20 - 24 days
Number of days since patient was administered until discharge in hospitals
次要结局
- Post-administration clinical and radiological improvement(Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day)
- Adverse Event and Serious Adverse Event Evaluation(20 - 24 days)
研究者
Bintang Soetjahjo, SpOT (K), MD. PhD
Coordinating Investigator
Dr. Moewardi General Hospital, Surakarta, Indonesia