Therapeutic Solutions International Announces ApoptoCyte Procedure for Enhancing Stem Cell Activity

Rhea-AI Summary

Therapeutic Solutions International announced a novel procedure, ApoptoCyte, enhancing the anti-inflammatory effects of mesenchymal stem cells. Data from a patent application indicates that combining apoptotic bodies with FDA-approved agents demonstrates superior therapeutic activity in animal models compared to traditional methods. This method potentially simplifies FDA approval processes due to minimal manipulation of stem cells. The company has cleared a Phase III trial for its JadiCell product in lung failure due to COVID-19, showing promising results over other stem cells.

Positive

• Novel ApoptoCyte procedure shows superior anti-inflammatory properties from apoptotic bodies in combination with FDA-approved agents.
• Potential for easier FDA approval process due to minimal manipulation of stem cells.
• JadiCell product has cleared a Phase III clinical trial for lung failure due to COVID-19.

Negative

• None.

Research Findings Associated with Company’s COVID-19 Program Yield Potentially Paradigm Shifting Intellectual Property

OCEANSIDE, Calif.--(BUSINESS WIRE)-- Therapeutic Solutions International announced today data on what the Company believes to be a novel procedure to enhance anti-inflammatory and regenerative activity of all mesenchymal stem cells. The findings reported in the filed patent application show that co-administration of stem cell derived apoptotic bodies, together with specific FDA cleared agents, results in superior therapeutic activity in animal models of inflammation and neurodegeneration as compared to injection of conventional stem cells.

“The conventional paradigm in regenerative medicine has been that mesenchymal stem cells produce growth factors, and for this they need to be alive,” said Dr. Thomas Ichim, Director of the Company. “Despite this, there have been some excellent studies showing that stem cells rapidly die when they contact blood, indicating the potential that therapeutic activity may be mediated by products released by dying stem cells.  The ApoptoCyte procedure, which is applicable to all mesenchymal stem cells, involves induction of cellular suicide in the stem cell, extraction of small vesicles called “apoptotic bodies” and co-administration with specific drugs such as certain histone deacetylase (HDAC) inhibitors.”

Apoptotic bodies alone can possess pro-inflammatory or anti-inflammatory properties, the ApoptoCyte procedure which involves co-administration of agents such as HDAC inhibitors ensures that apoptotic bodies interact with monocytes in the patient to produce approximately 3-5 times more anti-inflammatory cytokines such as interleukin-10.

“As a physician who has administered various stem cells, I have witnessed first-hand their ability to help patients who have failed conventional therapies. Unfortunately, not all patients respond, which has significantly impeded efforts to obtain FDA approval for many companies in the space,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “Given that this procedure involves minimal manipulation of stem cells and co-administration of drugs already approved, we believe FDA requirements for applying this procedure to existing programs will be minimal.”

The ApoptoCyte procedure was developed during experiments with the JadiCell™ mesenchymal stem cell which the Company has licensed for used in Lung Pathology, Chronic Traumatic Encephalopathy (CTE), and Traumatic Brain Injury (TBI). The FDA has cleared a Phase III clinical trial for the JadiCell product in lung failure due to Covid-19.  Use of the JadiCell for CTE is subject of a filed IND #27377 for which the Company is in the process of responding to FDA questions.

“At Therapeutic Solutions International we are always working on optimizing our therapies and drug development,” said Timothy Dixon, President and CEO of the Company. “Current data seems to indicate the superiority of the JadiCell in biological activities related to COVID-19 when compared to other mesenchymal stem cells.  However, we believe the ApoptoCyte procedure will eventually be implemented in our programs as well as potentially collaborating with other companies in the space for licensing purposes.”

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/

View source version on businesswire.com: https://www.businesswire.com/news/home/20220307005467/en/

Timothy G. Dixon

ir@tsoimail.com

 

Source: Therapeutic Solutions International

FAQ

What is the ApoptoCyte procedure related to TSOI?

The ApoptoCyte procedure enhances anti-inflammatory activity by co-administering apoptotic bodies with FDA-approved agents, potentially benefiting various mesenchymal stem cells.

What are the clinical trial results for JadiCell under TSOI?

The JadiCell product has received FDA clearance for a Phase III clinical trial targeting lung failure due to COVID-19.

How does TSOI's research impact the treatment of inflammation and neurodegeneration?

Research suggests that the ApoptoCyte procedure may lead to significantly improved therapeutic outcomes in treating inflammation and neurodegeneration.