6 Jan. 2021. Results of a clinical trial show stem cells from umbilical cord linings help patients with severe respiratory disease recover and survive from Covid-19 infections. Findings from the trial, led by researchers at University of Miami in Florida, appear in yesterday’s issue of the journal Stem Cells Translational Medicine.
A team led by Camillo Ricordi, director of the Diabetes Research Institute, affiliated with University of Miami, seeks to determine the safety and effectiveness of mesenchymal or mature stem cells derived from donated umbilical cords as a treatment for acute respiratory distress syndrome, or ARDS, a complication of Covid-19 infections. ARDS occurs in severe Covid-19 infection cases, causing inflammation and scar tissue that damage air sacs in the lungs, leading to respiratory failure, and often requiring long-term intensive care and mechanical ventilation.
Mesenchymal stem cells are extracted from the lining of donated umbilical cords, and kept frozen in stem cell banks for later therapeutic use. Previous use of these stem cells, say the authors, show they’re safe for patients, despite being allogeneic, or from genetically dissimilar donors, and have demonstrated efficacy with inflammatory and immune-related disorders. In addition, say the researchers, umbilical cord stem cells seek out sites of injuries or inflammation, limiting the chance for adverse side effects.
Two infusions of 100 million stem cells
The early- and mid-stage clinical trial tested mesenchymal stem cell infusions with 24 patients hospitalized with Covid-19 infections and with low blood oxygen levels requiring supplemental oxygen. Participants were randomly assigned to receive infusions of stem cells, plus the blood thinner heparin, or a placebo and heparin. “Two infusions of 100 million stem cells were delivered within three days,” says Ricordi in a university statement, “for a total of 200 million cells in each subject in the treatment group.”
The study team looked primarily for safety issues from the stem cell infusions, up to 90 days following treatment. The results show eight participants receiving stem cells experienced subsequent adverse events, with two of those events deemed severe. None of the severe adverse events, however, were related to the treatments.
The researchers also tracked efficacy indicators, from six to 90 days following infusions. After six days, stem cell recipients showed fewer inflammatory cytokines, a damaging reaction to Covid-19 infections known as cytokine storms, than placebo recipients. In addition, some 80 percent of stem cell recipients recovered within 30 days, compared to 37 percent of placebo recipients. Moreover, stem cell recipients had a higher likelihood of survival without severe adverse events than placebo recipients.
“It seemed to me that these stem cells could be an ideal treatment option for severe Covid-19,” notes Ricordi. “It requires only an intravenous infusion, like a blood transfusion. It’s like smart bomb technology in the lung to restore normal immune response and reverse life-threatening complications.”
Mesenchymal stem cells from bone marrow are already being commercially developed for treating ARDS. As reported by Science & Enterprise in November 2020, drug maker Novartis is licensing a stem cell treatment for ARDS from the Australian company Mesoblast Ltd., in a deal valued at $1.36 billion if all aspects are fulfilled.
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- Trial Shows Stem Cell Therapy Slows M.S. Progression
- ALS Stem Cell Therapy Fails to Meet Trial Objective
- FDA to Use Lung Chip Model for Covid-19 Testing
- Grant Funds Placenta Stem Cell Trial Sites for Covid-19
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