Therapeutic Solutions Gets FDA OK to Initiate Phase III for Universal Donor COVID Therapy

 Adult Stem Cell Therapy Previously Demonstrated to Block Inflammation While Regenerating Injured Tissue to Enter Final Phase of Testing

Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today clearance from the Food and Drug Administration (FDA) to initiate a Phase III pivotal trial for registration of the Company's JadiCell™ universal donor stem cell as a treatment for COVID-19 associated lung failure.

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, the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%1.

"We are thankful for the strong regulatory, basic research and translational team that has worked in successfully obtaining this FDA clearance," said Dr. Thomas E. Ichim, Director of the Company. "FDA clearance to initiate a Phase III clinical trial means we are at the last phase of development before commercially selling the product. This positions us in a highly exclusive place in that to our knowledge no other cells have this potent ability to concurrently suppress inflammation while restoring function of tissue damaged by SAR-CoV-2."

https://finance.yahoo.com/news/therapeutic-solutions-international-receives-fda-130000153.html