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.