Therapeutic Solutions to Apply for Emergency Use for Phase 3 COVID-19 Stem Cell Therapy

 Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today initiation of preparation for filing an Emergency Use Authorization (EUA) to the FDA for JadiCells™ in treatment of COVID-19 associated lung injury. 

The EUA is a mechanism that allows FDA to help strengthen the nation’s public health protections against threats such as infectious diseases by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under this provision, the FDA may authorize unapproved medical products to be used in an emergency to treat serious or life-threatening diseases or conditions.

“The extremely promising preclinical data we are generating, as well as the previously published double blind FDA clinical trial and most recently, FDA clearance to enter Phase III, strongly supports the rationale to file for Emergency Use Authorization” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “As a practicing physician, myself and my colleagues are eager to begin using these cells and potentially saving lives”.

In previous studies the Company has demonstrated the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, in an FDA double blind clinical trial the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 ICU patients1 under the age of 85. On August 5th, 2021, the FDA granted clearance for initiation of a Phase III pivotal trial using JadiCells to treat COVID-192.

https://therapeuticsolutionsint.com/therapeutic-solutions-international-prepares-to-apply-for-emergency-use-authorization-eua-for-its-fda-phase-iii-covid-19-stem-cell-therapy-jadicell/