Alercell is actively researching applications for the use of stem cells as a “cure” for COVID-19. The goal of the research is the use of stem cell treatment as a remedy for COVID-19, especially as we wait for development of proven, effective vaccines.
One of the challenges for the development of an effective COVID-19 vaccine is the specificity and the length of time needed to develop and gain regulatory approval of a vaccine. Due to previous available research and existing approvals, a stem cell approach is a faster solution with the advantage of adaptability as the virus changes.
Alercell is currently exploring a strategic partnership with a stem cell research company to see how a full treatment could be combined with the current Alercell strategy.
Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against public threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a public pandemic when there are no adequate, approved, and available alternatives.
FDA has issued about 175 EUA authorizations and is in the process of reviewing and terminating some authorizations based on failure to validate through independent NCI review.
Alercell has run its internal validation on several EUA authorized Antibody Tests and has retained only three companies to distribute as the Alercell Research supports that these tests are efficient, valid and have an accuracy superior to 95%.
Buying Alercell products means buying a quality test that will not become obsolete.
Alercell has researched the production capacity of various manufacturers. Several manufacturers have developed Tests but have limited industrial capacity. Alercell has the capacity to deliver tests in very large quantities.