Therapeutic Solutions International Subsidiary Allogen Biologics Inc. Successfully Manufactures JadiCell Master Cell Bank to Provide Cells for Right to Try Use and Phase III ARDS Clinical Trial

Rhea-AI Summary

Therapeutic Solutions International (TSOI) has achieved a significant production milestone by successfully generating a quality control tested Master Cell Bank of its JadiCell universal donor stem cell product. This allows the company to conduct a Phase III clinical trial with cells possessing FDA-approved characteristics. Previously, the JadiCells demonstrated a 100% reduction in lethality in COVID-19 patients under 85 years old in a Phase I/II clinical trial. The manufacturing of JadiCells in-house by Allogen Biologics will increase the number of patients that can be treated and generate more data in a shorter time period.

Clinical Stage Cell Therapy Company Achieves Significant Production Milestone

ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International, Inc. (TSOI), reported today successfully generation of a quality control tested Master Cell Bank comprised of its JadiCell universal donor stem cell product. Prior to this, the Company relied on third party manufacturing, which carried significantly more costs as well as potential regulatory uncertainty. The recently generated cells possessed both functional and phenotypic characteristics that the FDA has agreed to in its clearance of the Company to conduct a Phase III clinical trial.

Previously the JadiCells have demonstrated 100% reduction in lethality in COVID19 patients under 85 years old in a double-blind Phase I/II clinical trial¹.

“At the Veltmeyer Institute we provide JadiCells to “no option” patients under the Right to Try Law. Under this program we have documented remarkable recoveries in patients with various conditions such as Amyotrophic Lateral Sclerosis (ALS), Chronic Traumatic Encephalopathy (CTE), epilepsy, and schizophrenia. These findings serve as the basis for ongoing clinical development,” said Dr. James Veltmeyer, Chief Medical Officer of the Veltmeyer Institute and of Therapeutic Solutions International. “The manufacturing of JadiCells by Allogen Biologics allows for significant increase in the number of patients we can treat, and therefore generation of significantly more data in a short time period.”

“Dr. Ichim, who led the efforts for Allogen Biologics in generating JadiCells in house has cleared 5 Investigational New Drug applications in the area of cell therapies. The quality of work conducted by his team is second to none,” said Timothy Dixon, President and CEO of Therapeutic Solutions International. “By having the manufacturing process under our control, we believe we are positioned to accelerate our clinical programs while providing cells for clinical use to the Veltmeyer Institute and other researchers.”

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 Lanzoni et al. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial. Stem Cells Transl Med . 2021 May;10(5):660-673.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230816569973/en/

Timothy G. Dixon

ir@tsoimail.com

Source: Therapeutic Solutions International, Inc.

FAQ

What is the name of the company mentioned in the press release?

The company mentioned in the press release is Therapeutic Solutions International, Inc. (TSOI).

What milestone has TSOI achieved?

TSOI has achieved the milestone of successfully generating a quality control tested Master Cell Bank of its JadiCell universal donor stem cell product.

What is the significance of this milestone?

This milestone allows TSOI to conduct a Phase III clinical trial with cells possessing FDA-approved characteristics.

What positive results were obtained in a previous clinical trial?

In a Phase I/II clinical trial, the JadiCells demonstrated a 100% reduction in lethality in COVID-19 patients under 85 years old.

Who provides JadiCells to 'no option' patients?

JadiCells are provided to 'no option' patients by the Veltmeyer Institute.

What conditions have shown remarkable recoveries with JadiCells?

JadiCells have shown remarkable recoveries in patients with conditions such as Amyotrophic Lateral Sclerosis (ALS), Chronic Traumatic Encephalopathy (CTE), epilepsy, and schizophrenia.

Who led the efforts for Allogen Biologics in generating JadiCells in-house?

Dr. Ichim led the efforts for Allogen Biologics in generating JadiCells in-house.

How many Investigational New Drug applications has Dr. Ichim cleared?

Dr. Ichim has cleared 5 Investigational New Drug applications in the area of cell therapies.

What are the benefits of having the manufacturing process under control?

Having the manufacturing process under control allows TSOI to accelerate their clinical programs while providing cells for clinical use to the Veltmeyer Institute and other researchers.