ELK CITY, Idaho, Aug. 9, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today successful completion of a series of preclinical experiments requested by the United States Food and Drug Administration (FDA) in order to begin Phase I/II clinical trials.
The Company, which possesses the only filed Investigational New Drug (IND) application for treatment of chronic traumatic encephalopathy (CTE) was requested by the FDA to perform a series of experiments confirming several of the known properties of the JadiCell™ stem cells. With the completion of these experiments, the Company is cautiously optimistic to be granted clearance to initiate this "first in class" new treatment approach for CTE.
"The fact that the FDA accepted our definition of CTE as diagnosed in living patients is in our opinion, a major breakthrough" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "The experiments conducted demonstrate safety of the JadiCells™ in several different systems. We applaud the diligence and high level of scrutiny that the FDA has applied to our clinical trial and look forward to utilizing this novel approach to addressing this serious unmet medical need."
CTE is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players. The condition is characterized by memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia. In many patients with CTE, it is anatomically characterized by brain atrophy, reduced mass of frontal and temporal cortices, and medial temporal lobe. TSOI has previously filed several patents in the area of CTE based on modulating the brain microenvironment to enhance receptivity of regenerative cells such as stem cells.
"Given the recent FDA clearance1 for us to initiate Phase III clinical trials in COVID-19 using the same cells, we are enthusiastic to cross pollinate information learned from each of the trials as they proceed" said Timothy Dixon, President and CEO of the Company. "It is our honor to develop potential treatments that may help, in addition to athletes, military veterans who have given their lives and their bodies for our Country."
About Therapeutic Solutions International, Inc.
Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is www.therapeuticsolutionsint.com, and our public forum is https://board.therapeuticsolutionsint.com/
1Therapeutic Solutions International Receives FDA Clearance to Initiate Phase III Pivotal Registration Trial for JadiCell™ Universal Donor COVID-19 Therapy
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SOURCE Therapeutic Solutions International
