Therapeutic Solutions International Completes FDA Requested Studies to Initiate JadiCell™ Chronic Traumatic Encephalopathy (CTE) Clinical Trial

Rhea-AI Summary

Therapeutic Solutions International (OTC: TSOI) has completed FDA-requested preclinical experiments to initiate Phase I/II clinical trials for JadiCell™ treatment of chronic traumatic encephalopathy (CTE). This marks a significant milestone as TSOI holds the sole Investigational New Drug application for CTE. The FDA's acceptance of their CTE definition for living patients is viewed as a breakthrough. TSOI aims to leverage insights from ongoing COVID-19 trials to enhance treatment for CTE, addressing a critical medical need for athletes and military veterans.

Positive

• Successful completion of FDA-requested preclinical experiments.
• Preparation for initiating Phase I/II trials for JadiCell™ treatment of CTE.
• FDA acceptance of CTE definition for living patients is considered a breakthrough.
• Potential to leverage findings from COVID-19 trials for CTE treatment development.

Negative

• None.

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/ 

1 Therapeutic Solutions International Receives FDA Clearance to Initiate Phase III Pivotal Registration Trial for JadiCell™ Universal Donor COVID-19 Therapy

ir@tsoimail.com

 

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SOURCE Therapeutic Solutions International

FAQ

What are the latest developments for TSOI regarding CTE clinical trials?

TSOI has completed FDA-requested preclinical experiments and is preparing to initiate Phase I/II clinical trials for JadiCell™ treatment of chronic traumatic encephalopathy (CTE).

What does the FDA's acceptance of TSOI's CTE definition mean?

The FDA's acceptance of TSOI's CTE definition is regarded as a major breakthrough for the company's clinical approach to treating CTE in living patients.

How does TSOI's research on COVID-19 relate to CTE treatment?

TSOI plans to use insights gained from COVID-19 trials to inform and enhance the development of their CTE treatment strategies.

When will TSOI begin its Phase I/II trials for CTE?

TSOI is currently in preparation to initiate Phase I/II clinical trials for JadiCell™ treatment of CTE following successful preclinical studies.