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The use of mesenchymal stem cells infusion therapy appears to be safe in individuals having low clinical risk COVID-19 infection.
A randomized clinical trial provided favorable results regarding the safety of intravenous infusions of mesenchymal stem cells in patients having low clinical risk COVID-19. Researchers determined tolerability, safety, and feasibility of two doses ( low and high) of mesenchymal stem cells in coronavirus-infected patients.
In this phase 1, placebo-controlled, double-blind study, 9 participants were recruited and randomly segregated into low-dose, high-dose, and placebo groups. Participants in the low-dose and high-dose groups were given single intravenous infusions of 5.0 × 107 cells and 1.0 × 108 cells, respectively.
The treatment-emergent adverse events incidences during the 28-day trial period was the primary endpoint. During the observation period, monitoring of vital signs and numerous inflammatory markers was also done. At baseline, there were no apparent differences reported in clinical characteristics between the three study groups.
During the trial period, none of the participants showed severity progression. In 5 participants, six episodes of treatment-emergent adverse events were noted. But, none of the adverse events were serious. During follow-up, eight participants recovered and were discharged from hospital without any complexities. At the end of the trial, 1 participant showed abnormal liver function biomarkers. Throughout the clinical course, alterations in inflammatory markers were not immensely distinct across the trial groups.
Thus, the use of mesenchymal stem cells is safe for people with a low clinical risk COVID-19 infection. But, additional large-scale randomized controlled trials are warranted to further confirm the therapeutic effectiveness of mesenchymal stem cells in individuals with varying severity profiles for coronavirus disease.
Stem Cell Research & Therapy
Safety of DW-MSC infusion in patients with low clinical risk COVID-19 infection: a randomized, double-blind, placebo-controlled trial
Muhammad Karyana et al.
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