Column: Mind You
www.dailytargum.com
The 2019 coronavirus disease (COVID-19) has predominated recent international news cycles as the disease ignites widespread health concerns, disrupts the economy and continues to spread with marked rapidity.
COVID-19 is a member of the coronavirus family, a family also including severe acute respiratory syndrome and Middle East respiratory syndrome, which have sparked health crises of their own in past decades. Although no effective treatment or vaccine exists yet for COVID-19, initiatives around the world have begun to prevent the spread of the disease, as well as control its symptoms.
Among these initiatives is a promising path to treating the respiratory and inflammatory complications which make COVID-19 so life-threatening — stem cells.
Coronaviruses, such as COVID-19, have deadly effects because they cause “cytokine storms.” These storms result from imbalances between pro-inflammatory and anti-inflammatory cytokines, a type of protein, and they can cause extreme inflammation levels and respiratory complications. Respiratory distress kills as many as a million people every year, and as such hundreds of clinical trials are testing drugs for its treatment.
Recently, the U.S. company Athersys Inc. reported that a high dose of its stem cell product, MultiStem, had positive outcomes for patients with respiratory distress in a clinical trial by reducing mortality, dependence on ventilators and time spent in intensive care units. But, the results of this trial are currently unpublished and no stem cell product has been approved for clinical use so far in patients with respiratory distress.
The use of stem cells to treat inflammatory diseases and cytokine storms is hardly a new concept. The Australian company Mesoblast Limited owns a stem cell product named Remestemcel-L, which is already approved for clinical use in graft rejection disease in Japan (and is pending approval for this disease in the United States).
Like coronaviruses, graft rejection disease is associated with cytokine storms. Remestemcel-L has also been effective at moderate doses in treating advanced cases of respiratory distress where other therapies have failed.
Remestemcel-L has shown itself to be a safe treatment in all clinical trial reports and, given that Japanese regulations on stem cell products are designed to accelerate the approval of safe stem cell therapies for clinical use, Remestemcel-L should now be considered as a treatment for severe COVID-19.
Clinical trials in China are already testing the effectiveness of stem cell therapies for COVID-19. A recent clinical trial in China including COVID-19 patients showed that a stem cell product improved their outcomes and rebalanced cytokines to more normal levels. Four new clinical trials are using similar types of stem cells derived from umbilical cord blood.
But, the intravenous dose in these trials are only one quarter of the effective dose of Remestemcel-L. Such a low dose has been reported to be ineffective in past trials. Therefore, there is concern that the doses in these trials may be too low to be effective in COVID-19 patients.
Large banks of validated mesenchymal stem cells (MSC) are available now at several organizations, including Mesoblast Limited and Athersys Inc. Mesenchymal stem cells are noteworthy among other stem cells since they are less likely to produce an immune response in the body and are anti-inflammatory. If MSCs are to be used to combat COVID-19, determining an optimal dose is of utmost importance.
A recent Rutgers article shows that, among the hundreds of clinical trials registered with the U.S. Food and Drug Administration using MSCs, only a small percentage have reported results.
Therefore, it is difficult as of now to assess an optimal dose.
The results, which have been reported, suggest that the doses proposed in the four recent trials in China may be too low to be effective and that the dose used by Athersys Inc. for MultiStem may be too high to be maximally effective. Thus, maximizing success in clinical trials may entail testing a range of doses.
Other therapies are being pursued urgently for COVID-19, but they are months or years away from approval. Dr. Anthony Fauci, from the National Institute of Allergy and Infectious Diseases, said, “in order to get a vaccine that's practically deployable for people to use, it's going to be at least a year to a year and a half at best.”
Gilead Sciences Inc. has just launched a Phase 3 clinical trial to evaluate the safety and antiviral activity of the drug Remdesivir (which is effective against coronaviruses in animal studies) in patients with moderate COVID-19 and results are expected this May. In the meantime, the lack of promising and available treatments weighs heavily on the international community.
COVID-19 has proven not only to be a highly infectious disease, but also a deeply demoralizing one as well. The more quickly that governments approve the use of clinically safe treatments for COVID-19, the less damage the disease will do both as a life-threatening illness and as a force which threatens to strain international ties, intranational morale and economic institutions.
Given the safety of the aforementioned stem cell products and their efficacy, regulatory agencies should have discussions with companies about the compassionate treatment of severe COVID-19 cases with stem cells.
At the least, such discussions may provide needed optimism to allay the current COVID-19 panic and give patients hope for cures.
Daniel Bernstein is a School of Arts and Sciences first-year looking to major in cognitive science and biomathematics. His column, "Mind You," runs on alternate Fridays.
BERNSTEIN: Stem cell therapy may ameliorate severity of, concerns over coronavirus
The 2019 coronavirus disease (COVID-19) has predominated recent international news cycles as the disease ignites widespread health concerns, disrupts the economy and continues to spread with marked rapidity.
www.dailytargum.com
The 2019 coronavirus disease (COVID-19) has predominated recent international news cycles as the disease ignites widespread health concerns, disrupts the economy and continues to spread with marked rapidity.
COVID-19 is a member of the coronavirus family, a family also including severe acute respiratory syndrome and Middle East respiratory syndrome, which have sparked health crises of their own in past decades. Although no effective treatment or vaccine exists yet for COVID-19, initiatives around the world have begun to prevent the spread of the disease, as well as control its symptoms.
Among these initiatives is a promising path to treating the respiratory and inflammatory complications which make COVID-19 so life-threatening — stem cells.
Coronaviruses, such as COVID-19, have deadly effects because they cause “cytokine storms.” These storms result from imbalances between pro-inflammatory and anti-inflammatory cytokines, a type of protein, and they can cause extreme inflammation levels and respiratory complications. Respiratory distress kills as many as a million people every year, and as such hundreds of clinical trials are testing drugs for its treatment.
Recently, the U.S. company Athersys Inc. reported that a high dose of its stem cell product, MultiStem, had positive outcomes for patients with respiratory distress in a clinical trial by reducing mortality, dependence on ventilators and time spent in intensive care units. But, the results of this trial are currently unpublished and no stem cell product has been approved for clinical use so far in patients with respiratory distress.
The use of stem cells to treat inflammatory diseases and cytokine storms is hardly a new concept. The Australian company Mesoblast Limited owns a stem cell product named Remestemcel-L, which is already approved for clinical use in graft rejection disease in Japan (and is pending approval for this disease in the United States).
Like coronaviruses, graft rejection disease is associated with cytokine storms. Remestemcel-L has also been effective at moderate doses in treating advanced cases of respiratory distress where other therapies have failed.
Remestemcel-L has shown itself to be a safe treatment in all clinical trial reports and, given that Japanese regulations on stem cell products are designed to accelerate the approval of safe stem cell therapies for clinical use, Remestemcel-L should now be considered as a treatment for severe COVID-19.
Clinical trials in China are already testing the effectiveness of stem cell therapies for COVID-19. A recent clinical trial in China including COVID-19 patients showed that a stem cell product improved their outcomes and rebalanced cytokines to more normal levels. Four new clinical trials are using similar types of stem cells derived from umbilical cord blood.
But, the intravenous dose in these trials are only one quarter of the effective dose of Remestemcel-L. Such a low dose has been reported to be ineffective in past trials. Therefore, there is concern that the doses in these trials may be too low to be effective in COVID-19 patients.
Large banks of validated mesenchymal stem cells (MSC) are available now at several organizations, including Mesoblast Limited and Athersys Inc. Mesenchymal stem cells are noteworthy among other stem cells since they are less likely to produce an immune response in the body and are anti-inflammatory. If MSCs are to be used to combat COVID-19, determining an optimal dose is of utmost importance.
A recent Rutgers article shows that, among the hundreds of clinical trials registered with the U.S. Food and Drug Administration using MSCs, only a small percentage have reported results.
Therefore, it is difficult as of now to assess an optimal dose.
The results, which have been reported, suggest that the doses proposed in the four recent trials in China may be too low to be effective and that the dose used by Athersys Inc. for MultiStem may be too high to be maximally effective. Thus, maximizing success in clinical trials may entail testing a range of doses.
Other therapies are being pursued urgently for COVID-19, but they are months or years away from approval. Dr. Anthony Fauci, from the National Institute of Allergy and Infectious Diseases, said, “in order to get a vaccine that's practically deployable for people to use, it's going to be at least a year to a year and a half at best.”
Gilead Sciences Inc. has just launched a Phase 3 clinical trial to evaluate the safety and antiviral activity of the drug Remdesivir (which is effective against coronaviruses in animal studies) in patients with moderate COVID-19 and results are expected this May. In the meantime, the lack of promising and available treatments weighs heavily on the international community.
COVID-19 has proven not only to be a highly infectious disease, but also a deeply demoralizing one as well. The more quickly that governments approve the use of clinically safe treatments for COVID-19, the less damage the disease will do both as a life-threatening illness and as a force which threatens to strain international ties, intranational morale and economic institutions.
Given the safety of the aforementioned stem cell products and their efficacy, regulatory agencies should have discussions with companies about the compassionate treatment of severe COVID-19 cases with stem cells.
At the least, such discussions may provide needed optimism to allay the current COVID-19 panic and give patients hope for cures.
Daniel Bernstein is a School of Arts and Sciences first-year looking to major in cognitive science and biomathematics. His column, "Mind You," runs on alternate Fridays.