Therapeutic Solutions International Reports Preclinical Efficacy of JadiCell Umbilical Cord Mesenchymal Stem Cells in Animal Model Resembling COVID-19 Delta Variant Associated Lung Pathology

Rhea-AI Summary

On July 27, 2021, Therapeutic Solutions International, Inc. (OTC Markets: TSOI) announced preliminary data showing that JadiCell, its universal donor adult stem cell product, significantly reduced lung injury in an animal model mimicking severe inflammation due to the COVID-19 delta variant. Experiments indicated that JadiCell decreased inflammatory cell infiltration and suppressed harmful proteins. Previous clinical trials showed a 91% survival rate in end-stage COVID-19 patients treated with JadiCell. The company is in discussions with the FDA for a Phase III clinical trial.

Positive

• JadiCell demonstrated significant reduction of pulmonary injury in animal studies, suggesting potential benefits for COVID-19 patients.
• Previous clinical trials indicated a survival rate improvement for COVID-19 patients from 42% to 91% with JadiCell treatment.
• The company is in discussions with the FDA regarding a Phase III clinical trial for JadiCell.

Negative

• None.

ELK CITY, Idaho, July 27, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), reported today preliminary data demonstrating administration of its universal donor adult stem cell product, JadiCell, reduced pulmonary pathology in an animal model replicating the severe inflammation observed in patients infected with the COVID-19 delta variant. In a series of experiments, mice were administered a synthetic version of viral compounds (Poly IC and spike protein) known to induce lung damage¹ in a manner resembling uncontrolled COVID-19. 

In contrast to other studies, the current experiments utilized significantly higher doses of the viral mimicking compounds in order to replicate infection with the delta variant. It is published that the delta variant evades various immune mechanisms of the body, therefore causing a significantly higher viral load as compared to the original virus².

JadiCell administration resulted in significant reduction of lung injury based on preservation of lung function, reduction of inflammatory cells entering the lung, and suppression of specific proteins such as C5a which are associated with poor prognosis in COVID-19 patients³.

"Aside from its enhanced infectivity rate and ability to escape various immune mechanisms, little is known about the delta variant," said Dr. James Veltmeyer, Chief Medical Officer of the Company. "Although the data reported today was based on animal studies, the significant suppression of lung damage, which we did not observe with other stem cells, supports the idea that the JadiCell may benefit patients with the delta variant."

In an FDA double blind, placebo controlled clinical trial the JadiCell was successful at substantially improving survival in end-stage patients with COVID-19 associated acute lung failure⁴. Specifically, treatment was associated with significantly improved patient survival (91% vs 42%).

"As a company we are committed to learning as much as we can about our cellular product from laboratory studies while we are concurrently in discussions with the FDA regarding our planned Phase III pivotal trial," said Timothy Dixon, President and CEO of the Company. "Given the unique ability of the JadiCell in animal studies to concurrently suppress cytokine storm while stimulating regenerative processes in the lung, combined with promising patient data, we are hopeful that our work will lead to a new weapon in our fight against this invisible enemy."

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 Molecular mechanism of SARS-Cov-2 components caused ARDS in murine model | bioRxiv
2 Reduced sensitivity of SARS-CoV-2 variant Delta to antibody neutralization | Nature
3 Complement Anaphylatoxins and Inflammatory Cytokines as Prognostic Markers for COVID-19 Severity and In-Hospital Mortality (nih.gov)
4 Umbilical cord mesenchymal stem cells for COVID–19 acute respiratory distress syndrome: A double–blind, phase 1/2a, randomized controlled trial - Lanzoni - 2021 - STEM CELLS Translational Medicine - Wiley Online Library

ir@tsoimail.com

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SOURCE Therapeutic Solutions International, Inc.

FAQ

What are the results of the latest study on JadiCell by Therapeutic Solutions International (TSOI)?

The study showed that JadiCell reduced lung injury in an animal model of COVID-19 delta variant inflammation.

What is the survival rate improvement in COVID-19 patients treated with JadiCell from TSOI?

The survival rate improved from 42% to 91% in end-stage COVID-19 patients treated with JadiCell.

Is Therapeutic Solutions International planning a Phase III trial for JadiCell?

Yes, the company is discussing a Phase III pivotal trial with the FDA for JadiCell.

What is the mechanism by which JadiCell helps in COVID-19 treatment?

JadiCell appears to reduce inflammatory cell infiltration and suppress harmful proteins related to lung injury.