Therapeutic Solutions International Comes to Agreement with FDA on Clinical Trial Design for First Stem Cell Clinical Trial in Chronic Traumatic Encephalopathy (CTE) Patients
Therapeutic Solutions International, Inc. (OTC Markets: TSOI) announced the FDA's acknowledgment of its IND application for a clinical trial aimed at treating chronic traumatic encephalopathy (CTE). This marks a significant milestone as the FDA recognizes CTE as a valid disease indication. The FDA has requested minor adjustments to the trial protocol, focusing on manufacturing, delivery, and patient monitoring. The company believes it is the only one pursuing regenerative therapeutics for CTE through regulatory channels, aiming to address the health issues faced by affected individuals.
- FDA recognizes CTE as a valid disease indication for therapeutic intervention.
- Company is proceeding with plans for regenerative-based therapies for CTE.
- Confidence expressed by executives in responding to FDA's requests.
- FDA requested several changes to the IND, which may delay the trial initiation.
- Concerns raised about exposing subjects to unknown risks, requiring protocol modifications.
ELK CITY, Idaho, April 30, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today receipt of a written communication from the Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application, which was granted number 27377.
"We are pleased that the FDA has thoroughly reviewed our proposed clinical trial and agrees with us that chronic traumatic encephalopathy (CTE) is a valid disease indication for potential therapeutic intervention," stated Dr. James Veltmeyer, Chief Medical Officer of the Company and Top Doctor of San Diego. "Classically, the perception is that CTE can only be diagnosed post-mortem. The fact that the FDA is open to allowing our protocol, with minor changes, strongly supports development of regenerative-based approaches for this terrible condition."
The FDA requested several changes to the IND and clarifications centered around manufacturing, delivery, and monitoring of the cellular product before patient treatment can be initiated.
In regard to recognition of CTE as a valid clinical indication, the FDA stated, "To limit the number of subjects being exposed to unknown but potentially significant risk(s), please modify your protocol to include an appropriate staggering period between consecutive subjects for the first several subjects." Additionally, the FDA requested that the Company potentially exclude pediatric patients and patients unable to provide proper informed consent.
"To our knowledge, we are the only entity actively developing regenerative based therapeutics for CTE through legitimate regulatory pathways," said Famela Ramos, Vice President of Business Development. "Society enjoys the entertainment of modern-day gladiators (football players) and the freedom and security afforded to us by our military. Unfortunately, these brave individuals are forgotten once they develop mental issues which are caused as a result of their occupation."
"As a Company, we are pleased that the FDA is open to our parameters for classifying CTE while patients are pre-mortem," said Timothy Dixon, President and CEO of the Company. "Based on the experiences of our clinical team and advisors, we are confident in responding to the FDA's questions in a timely manner."
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/
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