Therapeutic Solutions International Develops Novel Stem Cell Based Therapy to Reduce Lung Scarring: Potential Solution to Post COVID-19 Lung Deterioration

Rhea-AI Summary

Therapeutic Solutions International, Inc. (TSOI) announced significant advancements on May 21, 2021, regarding its JadiCell™ stem cell therapy. Recent data shows that lithium carbonate enhances JadiCell™'s ability to inhibit lung scarring, especially relevant for COVID-19 survivors. In clinical trials, JadiCell™ improved survival rates in patients with acute lung failure due to COVID-19, achieving 91% survival compared to 42% for controls. The company plans to start a phase III trial for regulatory approval to treat acute respiratory distress syndrome and other lung diseases.

Positive

• Data shows JadiCell™ is superior in inhibiting lung scarring compared to other stem cells.
• Clinical trial indicated a 91% survival rate in patients treated with JadiCell™ for COVID-19 related lung failure.
• Plans to initiate phase III pivotal registration trial for JadiCell™.
• Potentially addresses a significant market with 660,000 patients suffering from post-COVID lung fibrosis.

Negative

• None.

ELK CITY, Idaho, May 21, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today new data and patent filing demonstrating that the FDA cleared drug, lithium carbonate, substantially augments the scar inhibiting activity of its licensed JadiCell™ universal donor stem cell therapy. Furthermore, the data reveals that the JadiCell™ was superior to other stem cells at inhibiting development of lung scarring in the bleomycin model of pulmonary fibrosis.   

"After patients recover from COVID-19 approximately one-third of those who were hospitalized develop long-term scarring of the lung,¹" said Dr. James Veltmeyer, Chief Medical Officer of the Company. "There are no known treatments for this condition, and in some cases its progression leads to continuous deterioration in lung function.  We are currently developing the JadiCell™ for treatment of acute lung failure.  The data disclosed today suggests the possibility of expanding the use of JadiCell™ to address post-COVID lung failure, a condition which appears to be rising exponentially."

The use of JadiCells for treatment of lung pathology and COVID-19 is exclusively licensed and owned by Therapeutic Solutions International.  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 failure².  Specifically, treatment was associated with significantly improved patient survival (91% vs 42%, P = .015), Serious Adverse Event-free survival (P = .008), and time to recovery (P = .03).  The Company plans to initiate a phase III pivotal registration trial and seek marketing approval for use of JadiCell in acute respiratory distress syndrome (ARDS) and other lung diseases.

"There are at least 660,000 patients suffering from post-COVID lung fibrosis if you look at the CDC statistics reporting over 2,000,000 COVID-19 related hospitalizations,³" stated Famela Ramos, Vice President of Business Development for the Company. "To our knowledge Therapeutic Solutions International is the only Clinical Stage Cell Therapy company aggressively addressing not only the acute lung failure associated with COVID-19, but also its long-term consequences."

"The findings reported today are an excellent example of the cross-fertilization occurring between our Company and our Spin-off Campbell Neurosciences," said Timothy Dixon, President and CEO of Therapeutic Solutions International. "Who would have thought that a neurological acting drug, lithium carbonate, which is sold under the names Lithobid® and  Eskalith®, would have such potent ability to program stem cells to reduce scarring?  These sorts of discoveries are only possible when scientific groups of diverse interest are brought together and provided resources to let their imagination run rampant."

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 Post COVID-19 fibrosis, an emerging complicationof SARS-CoV-2 infection (nih.gov)
² 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
³ COVID Data Tracker Weekly Review | CDC

ir@tsoimail.com

 

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SOURCE Therapeutic Solutions International

FAQ

What recent developments did Therapeutic Solutions International (TSOI) announce regarding JadiCell™?

On May 21, 2021, TSOI announced that lithium carbonate enhances JadiCell™ stem cell therapy, showing superior results in inhibiting lung scarring.

What were the survival rates in the clinical trial for JadiCell™?

The clinical trial reported a 91% survival rate in patients treated with JadiCell™ for acute lung failure, compared to 42% for the placebo group.

How is Therapeutic Solutions International addressing post-COVID lung fibrosis?

TSOI plans to initiate a phase III trial for JadiCell™ aimed at treating acute respiratory distress syndrome and addressing the long-term consequences of COVID-19.

How many patients are estimated to suffer from post-COVID lung fibrosis according to TSOI?

TSOI estimates that approximately 660,000 patients are suffering from post-COVID lung fibrosis based on CDC statistics.