Therapeutic Solutions International Successfully Treats “No Option” Patients with its JadiCell™ Stem Cell Therapy While Advancing Preparations for Phase III COVID-19 Clinical Trial

Rhea-AI Summary

Therapeutic Solutions International (TSOI) reported successful treatment of 15 patients using the JadiCell™ adult stem cell product under the Right to Try Law. Notably, 12 COVID-19 patients showed profound recovery, and retired Navy SEALs exhibited significant improvement in biomarkers linked to Chronic Traumatic Encephalopathy (CTE). The company is advancing towards Phase III clinical trials for JadiCells, focusing on patient safety and treatment effectiveness amid ongoing COVID-19 challenges.

Positive

• Successful treatment of 15 patients with JadiCell™ under Right to Try Law.
• 12 COVID-19 patients showed profound recovery despite advanced disease stages.
• Improvement in biomarkers for CTE in retired Navy SEALs.
• Progress in preparations for Phase III clinical trial of JadiCells.

Negative

• None.

Company Accelerating Clinical Progress in Response to Omicron Outbreak by Pre-Trial Implementation in “Real Life” Clinical Situations Leveraging Right to Try Exemption

OCEANSIDE, Calif.--(BUSINESS WIRE)-- Therapeutic Solutions International (TSOI) announced today successful treatment of 15 recent patients under the Right to Try Law with the Company’s universal donor JadiCell™ adult stem cell product. All patients displayed no adverse events and demonstrated subjective and objective levels of improvement.

There were 12 COVID-19 patients who underwent a profound recovery despite advanced stage of disease, while the retired Navy SEAL that was previously publicly disclosed¹ along with two other retired SEALS, had a significant decrease in biomarkers associated with Chronic Traumatic Encephalopathy (CTE), as well as psychological improvement at the two month follow up.

“We are making progress in preparing for the upcoming Phase III clinical trial of JadiCells for treatment of COVID-19. This includes negotiation with the contract research organization, site recruitment and selection, as well as organization of trial logistics,” said James Veltmeyer, Chief Medical Officer of the Company. “Despite this, COVID-19 and variants of concern such as omicron, have the potential to wreak severe chaos on our healthcare system. We have literally saved lives with JadiCells and believe in making the treatment available as soon as possible under appropriate conditions.”

Under the Right to Try Law, companies are allowed to provide experimental therapies that have passed Phase I clinical trials to patients who in the opinion of the physician have no therapeutic options available to them.

“We plan to continue clinical implementation and data collection in a real time setting using JadiCells for patients whose physicians deem they qualify under Right to Try,” said Timothy Dixon, President and CEO of Therapeutic Solutions International. “Nothing makes me feel better as CEO of this Company than seeing firsthand our product saving lives. Now the mission is to make it available on a large scale, which we will.”

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 Successfully Treats Veteran Navy SEAL Suffering from Chronic Traumatic Encephalopathy with JadiCell™ Adult Stem Cells Under Right to Try Law

View source version on businesswire.com: https://www.businesswire.com/news/home/20211230005155/en/

Timothy G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International

FAQ

What is the trial phase for JadiCell™ treatment of COVID-19?

Therapeutic Solutions International is preparing for an upcoming Phase III clinical trial for JadiCells aimed at treating COVID-19.

How many patients were treated under the Right to Try Law?

Therapeutic Solutions International successfully treated 15 patients under the Right to Try Law.

What were the results for COVID-19 patients treated with JadiCell™?

12 COVID-19 patients demonstrated profound recovery after receiving JadiCell™ treatment.

What improvements were observed in patients with Chronic Traumatic Encephalopathy (CTE)?

Retired Navy SEALs showed significant decreases in biomarkers associated with CTE and psychological improvements after treatment.

What is the Right to Try Law?

The Right to Try Law allows companies to provide experimental therapies that have completed Phase I clinical trials to patients with no available therapeutic options, as per their physician's opinion.