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临床试验/NCT04313322
NCT04313322Unknown1 期

Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells

Stem Cells Arabia2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年3月16日最近更新:
适应症

试验速览

阶段
1 期
入组人数
5
试验地点
2
主要终点
CT Scan

研究概览

简要总结

The purpose of this study is to investigate the potential use of Wharton's Jelly Mesenchymal stem cells (WJ-MSCs) for treatment of patient diagnosed with Corona Virus SARS-CoV-2 infection, and showing symptoms of COVID-19.

详细描述

COVID-19 is a condition caused by infection with Coronoa Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates. causing a worldwide pandemic. Patients diagnosed with COVID-19 and confirmed positive with the virus, will be given three IV doses of WJ-MSCs consisting of 1X10e6/kg. The three doses will be 3 days apart form each other.

Patients will be followed up for a period of three weeks to assess the severity of the condition and measure the viral titers.

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

盲法说明

None. This is a direct study for the potential effects of WJ-MSCs on COVID-19 outcome.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.

排除标准

  • Participants in other clinical trials
  • patients with malignant tumors
  • pregnant and lactating women
  • co-infection with other infectious viruses or bacteria
  • History of several allergies
  • Patients with history of pulmonary embolism
  • any liver or kidney diseases
  • HIV positive patients
  • Considered by researchers to be not suitable to participate in this clinical trial
  • Chronic heart failure with ejection fraction less than 30%.

结局指标

主要结局

CT Scan

时间窗: 3 weeks

Side effects measured by Chest Readiograph

Clinical outcome

时间窗: 3 weeks

Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.

RT-PCR results

时间窗: 3 weeks

Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative

次要结局

  • RT-PCR results(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adeeb Al Zoubi

President, Chief Scientific Officer

Stem Cells Arabia

研究点 (2)

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