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临床试验/NCT04753476
NCT04753476Unknown2 期

The Effect of Secretome of Hypoxia-Mesenchymal Stem Cells in Improving Survival of Severe Covid-19 Patients

Stem Cell and Cancer Research Indonesia6 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年6月8日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
48
试验地点
6
主要终点
Change in patients clinical manifestation

研究概览

简要总结

In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells. The improvement in clinical, laboratory, and radiological manifestations will be evaluated in treated patients compared with the control group.

详细描述

The devastating effect of severe acute respiratory syndrome coronavirus-2 (SARS COV-2) infection is caused by a robust cytokine storm that leads to lung tissue damage. Several studies reported a correlation between disease severity and the release of excessive proinflammatory cytokines, such as tumor necrosis factor-α (TNF-α), IL-6, IL-1, IFN-Υ, IFN-Υ-induced protein 10 (IP10), monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory protein-1a (MIP-1a), and granulocyte-colony stimulating factor (G-CSF). This finding was confirmed by the high level of plasma cytokines found in most severe COVID-19 patients associated with extensive lung damage. Therefore, finding an effective therapeutic option to control the devastating cytokine storm of COVID-19 and regenerate the damaged lung is crucial.

Previous studies reported that the hypoxic condition of MSCs could enhance the release of their active soluble molecules known as Secretome-MSCs (S-MSCs), such as IL-10 and TGF-β that useful in alleviating inflammation. Moreover, they could also increase the expression of growth factors such as VEGF and PDGF that accelerate lung injury improvement. These active molecules could potentially serve as a biological therapeutic agent for treating the severe SARS-CoV-2 infection. According to recent studies, we successfully isolated the S-MSCs from their culture medium using tangential flow filtration (TFF) strategy with several molecular weight cut-off category. This study investigated the clinical outcomes of severe COVID-19 patients with several comorbidities treated with S-MSCs in Indonesia.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients whose clinical and laboratory test results have a positive diagnosis of Covid-
  • Patients who are willing to participate as subjects in the study by signing the informed content.
  • Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator:
  • PaO2 / FiO2: moderate 100-200
  • PaO2 / FiO2: severe <100
  • One or more comorbid history

排除标准

  • The Covid19 patient has fibrosis (based on the results of the chest X-ray or CT chest)
  • ECOG 4 performance status, decreased irreversible consciousness, brain stem death.
  • Severe NYHA III / IV heart failure
  • Pregnant women

研究组 & 干预措施

Secretome-MSCs (n=24)

Experimental

This group will be given Covid-19 standard therapy with intramuscular Hypoxic S-MSC secretome

干预措施: Injection of Secretome-MSCs (Biological)

Secretome-MSCs (n=24)

Experimental

This group will be given Covid-19 standard therapy with intramuscular Hypoxic S-MSC secretome

干预措施: Standard treatment of Covid-19 (Drug)

Control (n=24)

Other

This group will receive standard Covid-19 therapy with the best supportive care

干预措施: Standard treatment of Covid-19 (Drug)

结局指标

主要结局

Change in patients clinical manifestation

时间窗: 1 months

mild, moderate, or severe

Need for a ventilator

时间窗: 1 months

There are respiratory variables that made severe Covid-19 patients previously stable but worsened, requiring a ventilator Divided into two categories: 1. It is necessary 2. No need

Routine blood profile

时间窗: 2 weeks

Obtained from patients before and after treatment

Photo thorax

时间窗: 2 weeks

Obtained from patients before and after treatment

Blood Gas Analisis (BGA)

时间窗: 2 weeks

Obtained from patients before and after treatment

Length of stay

时间窗: 1 months

The length of stay from the first treatment to the patient's final outcome, recovery, or death

CRP

时间窗: 2 weeks

Obtained from patients before and after treatment

Duration of using a ventilator

时间窗: 1 months

Duration of use of a ventilator from the day of intubation to the day of extubation

D-dimer

时间窗: 2 weeks

Obtained from patients before and after treatment

次要结局

  • Survival(2 months)

研究者

发起方
Stem Cell and Cancer Research Indonesia
申办方类型
Network
责任方
Principal Investigator
主要研究者

Agung Putra

Assoc. Prof. Dr. dr. Agung Putra, M.Si. Med

Stem Cell and Cancer Research Indonesia

研究点 (6)

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