A Phase 1/2 interventional study of Allogeneic human menstrual blood stem cells secretome and Intravenous saline injection in Covid19 and Cytokine Storm, sponsored by Avicenna Research Institute. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-02.
Sponsored by Avicenna Research Institute · Phase 1/2, Interventional, and Treatment
In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of menstrual blood stem cells. The improvement in the clinical, laboratory and radiological manifestations will be evaluated in treated patients compared with the control group.
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 have found that the severity of the disease is correlated with the release of excessive proinflammatory cytokines, such as IL-1, IL-6, IL-12, IFN-γ, and TNF-α, preferentially targeting lung tissue. This finding was confirmed by the high level of plasma cytokines found in the most severe COVID-19 patients associated with extensive lung damage. As a result, it is essential to find an effective treatment option to control the devastating cytokine storm of COVID-19 and regenerate the damaged lung. Although mesenchymal stem cells are a powerful tool for clinical applications, they have limits in terms of administration, safety, and variability of therapeutic response. It is interesting to note that the MSC secretome composed of cytokines, chemokines, growth factors, proteins, and extracellular vesicles could be a valid alternative to their use. It is not only easier to preserve, transfer and produce the secretome, but also safer to administer.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 29 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Avicenna Research Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous Allogeneic Menstrual Blood Stem Cells Secretome injection+Routine treatment
Biological: Allogeneic human menstrual blood stem cells secretome
Intravenous saline injection (Placebo)+Routine treatment
Other: Intravenous saline injection
This COVID-19 Study intervention consists of Intravenous Allogeneic human menstrual blood stem cell (MenSC) secretome injection in addition to standard care. The MenSC were characterized as CD90+, CD73+, CD105+, and CD45-based on multiparameter flow cytometry.
Intravenous saline injection in addition to standard care
Adverse reactions incidence
The proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.
Time frame: Day 0 - 28
Time to clinical improvement
Days from administration of the Investigational Product for improvement
Time frame: Day 0 - 28
Assessment of serum CRP (mg/L) levels
To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers
Time frame: Days 0, 5, 10, 14, and 28
Assessment of serum LDH (U/L) levels
To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers
Time frame: Days 0, 5, 10, 14, and 28
Assessment of serum Ferritin (ng/ml) levels
To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers
Time frame: Days 0, 5, 10, 14, and 28
Assessment of serum D-dimer (microgr/ml) levels
To evaluate the anti-inflammatory effect of the proposed treatment an assessment of the inflammatory markers
Time frame: Days 0, 5, 10, 14, and 28
Immunological changes on CD4+ T and CD8+ T
Evaluate immune system improvement with flow cytometry to analyze patients' immune cells
Time frame: Days 0, 5, 10, 14, and 28
Lung Involvement
Side effects measured by Chest Readiograph Side effects measured by Chest Readiograph
Time frame: Day 0 - 28
Changes in Inflammatory cytokine IL 6
To assess the anti-inflammatory effect of the proposed treatment an assessment of the levels of IL6 in plasma.
Time frame: Days 0, 5, 10, 14, and 28
Changes in anti-Inflammatory cytokine IL10
To assess the anti-inflammatory effect of the proposed treatment an assessment of the levels of IL10 in plasma.
Time frame: Days 0, 5, 10, 14, and 28
Plan to share: No
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Avicenna Research Institute