Therapeutic Solutions International Launches Subsidiary Company to Commercialize Clinical Data and IND for Treatment of Chronic Traumatic Encephalopathy (CTE) with JadiCell Universal Adult Stem Cells

Rhea-AI Summary

Therapeutic Solutions International (TSOI) has created CTE Biologics, Inc. as a subsidiary company to commercialize the JadiCell stem cell platform for treating chronic traumatic encephalopathy (CTE). The company has licensed the JadiCell for this indication and is addressing FDA questions before initiating clinical trials.

Positive

• Therapeutic Solutions International has created CTE Biologics, Inc. to focus on commercializing the JadiCell stem cell platform for CTE treatment.
• The FDA has agreed with the company's definition of CTE in living patients, a significant accomplishment.
• The safety of JadiCells has been demonstrated in a peer-reviewed publication, increasing the likelihood of clearance for formal trials.

Negative

• None.

ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International (TSOI) announced the creation of CTE Biologics, Inc. as a subsidiary company dedicated to commercializing the JadiCell adult stem cell platform for treatment of chronic traumatic encephalopathy.

This condition is caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years and is often found in football players and military veterans. Patients suffer from memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia.

Therapeutic Solutions International licensed the JadiCell for this indication in 2019¹, was granted IND number 27377 in April 2021², and is currently addressing questions from the FDA before initiations of formal clinical trials. The Company has provided JadiCells under the Right to Try Law for multiple patients suffering from Chronic Traumatic Encephalopathy³.

“Chronic Traumatic Encephalopathy is classically diagnosed after a patient is deceased. The fact that the FDA has agreed with our definition of this condition in living patients is a significant accomplishment,” said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International. “Given that safety of JadiCells has already been demonstrated in a peer reviewed publication⁴ subsequent to our interaction with the FDA suggests to me a high likelihood of clearance to initiate formal trials in Chronic Traumatic Encephalopathy.”

“Based on our preclinical and pilot clinical observations we believe that our approach to Chronic Traumatic Encephalopathy possesses potential to address a condition which currently is not even properly diagnosed in living patients,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “Creation of CTE Biologics allows for specialization and focus while leveraging existing resources within Therapeutic Solutions International.”

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.

1 Therapeutic Solutions International Obtains Exclusive (globenewswire.com)
2 Therapeutic Solutions International Comes to Agreement with FDA on Clinical Trial Design for First Stem Cell Clinical Trial in Chronic Traumatic Encephalopathy (CTE) Patients | BioSpace
3 Therapeutic Solutions International Successfully Treats “No Option” Patients with its JadiCell™ Stem Cell Therapy While Advancing Preparations for Phase III COVID-19 Clinical Trial | BioSpace
4 Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial - PubMed (nih.gov)

View source version on businesswire.com: https://www.businesswire.com/news/home/20230525005475/en/

Timothy G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International

FAQ

What is CTE Biologics, Inc.?

CTE Biologics, Inc. is a subsidiary company of Therapeutic Solutions International dedicated to commercializing the JadiCell stem cell platform for treating chronic traumatic encephalopathy (CTE).

What is CTE?

CTE stands for chronic traumatic encephalopathy, a condition caused by repetitive concussive/sub-concussive hits to the head sustained over a period of years. It is often found in football players and military veterans and is characterized by symptoms such as memory loss, impulsive/erratic behavior, impaired judgment, aggression, depression, and dementia.

What progress has been made with JadiCell for CTE treatment?

Therapeutic Solutions International has licensed the JadiCell for CTE treatment and has obtained FDA IND number 27377. The company is currently addressing FDA questions before initiating formal clinical trials.

Has JadiCell been used for CTE patients?

Under the Right to Try Law, Therapeutic Solutions International has provided JadiCells for multiple patients suffering from Chronic Traumatic Encephalopathy.

What is the significance of the FDA agreeing with the company's definition of CTE in living patients?

The FDA agreeing with the company's definition of CTE in living patients is a significant accomplishment as CTE is classically diagnosed after a patient is deceased.

Has the safety of JadiCells been demonstrated?

The safety of JadiCells has been demonstrated in a peer-reviewed publication, increasing the likelihood of clearance to initiate formal trials for CTE treatment.