The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system. This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death. We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC\_ASCs from adipose tissue. The aim is to assess the impact of CSCC\_ASCs on the activated immune system and clinical efficacy on pulmonary function. The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, Denmark
Changes in clinical critical treatment index
Time frame: day 7 from randomization
Days of respirator treatment
Time frame: 3 months
Improvement of clinical symptoms including duration of fever and respiratory need
Time frame: 3 months
Mortality
Time frame: 3 months
Marker of Immunological function -CD4+ and CD8+ T cell count
Time frame: 3 months
C-reactive protein and leucocyte
Time frame: 3 months
Cytokine profile
Time frame: 3 months
Glomerular Filtration Rate
Time frame: 3 months
Duration of hospitalization
Time frame: 3 months
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