Therapeutic Solutions International Files for Orphan Drug Designation Use of JadiCell Adult Stem Cells for Treatment of Frontotemporal Dementia

Company Sets Sights on Dreaded Disease that “Attacks at the Essence of One’s Humanity”

ELK CITY, Idaho--(BUSINESS WIRE)--Therapeutic Solutions International, Inc. (TSOI), a clinical stage regenerative medicine and immunotherapy company, announced today new data and filing with the FDA for Orphan Drug Designation of its JadiCell adult stem cell in the treatment of Frontotemporal Dementia. This neurodegenerative disease is the leading cause of dementia in patients under 60 years old and to date no therapies have been shown to reduce its progression¹.

Frontotemporal dementia is caused by a buildup of particular proteins that form clumps inside brain cells, causing brain inflammation and activation of certain immune cells which result in damage to the frontal and temporal lobes. These patients eventually die of the disease but before death suffer horrific effects. For example, in the behavioral variant, which is the most common form of the condition, severe personality changes occur, which include apathy, and a progressive decline in socially appropriate behavior, judgment, self-control, and empathy. In the primary progressive aphasia variant of this condition, gradual loss of the ability to speak, read, write, and understand what others are saying occurs, basically isolating the patient.

‘We have previously had success in treating patients suffering from chronic traumatic encephalopathy (CTE) using the JadiCell cell therapy product, administered under the Right to Try Law,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “Recent in vitro and animal data suggests the possibility of utilizing these cells in Frontotemporal Dementia, which possesses some molecular similarities to CTE.”

Various inflammatory mechanisms have been implicated in disease progression in both chronic traumatic encephalopathy and frontotemporal dementia. One area of particular interest is the ability of JadiCells to inhibit inflammasome activation as well as downstream chemical messengers of this inflammatory pathway, while concurrently stimulating regeneration of damaged neurons.

“Our new data and the recent findings supporting the possibility of JadiCell-based neural regeneration for Frontotemporal Dementia supports the idea that the JadiCell platform can be leveraged in a variety of disease indications,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “We are excited that we can begin offering this treatment today based on the established clinical history and safety profile of this immune modulatory cellular therapy.”

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 Understanding Frontotemporal Dementia, the Leading Cause of Dementia in People under Age 60 - Scientific American