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)
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Contacts
Timothy G. Dixon
ir@tsoimail.com
