Therapeutic Solutions International Selects Premier Regenerative Medicine CRO Biorasi to Initiate and Run Phase III FDA Registration Clinical Trial for JadiCell™ Universal Donor Adult Stem Cell Product

Rhea-AI Summary

Therapeutic Solutions International (TSOI) has appointed Biorasi as the contract research organization to conduct its Pivotal FDA Registration Clinical Trial for the JadiCell™ Adult Stem Cell Product, aimed at treating advanced COVID-19. The trial is a continuation of previous research that achieved a 100% survival rate in patients under 85. JadiCells™ show promising therapeutic activity for lung conditions. The trial will expand internationally, with India and another Latin American country involved, furthering TSOI's pursuit to be the first to market stem cell treatments for lung regeneration.

Positive

• Achieved 100% survival rate in patients under 85 in previous trials.
• JadiCells™ show therapeutic activity for lung conditions.
• International trial expansion includes India and potential Latin American countries.

Negative

• None.

Company Aims to be “First to Market” Utilizing Stem Cells to Treat and Repair COVID-19 Injured Lungs

OCEANSIDE, Calif.--(BUSINESS WIRE)-- Therapeutic Solutions International announced today its Board of Directors has selected Biorasi as the contract research organization (CRO) to run its Pivotal FDA Registration Clinical Trial assessing efficacy of its JadiCell™ Adult Stem Cell Product in patients with advanced COVID-19.

The clinical trial was cleared by the FDA as a continuation of its previous clinical trial which treated the most severe cases of COVID-19 with stem cell infusions. The unprecedented results allowed for 100% patient survival at one month in subjects treated who were less than 85 years old, and 91% survival in subjects of all ages, compared to 42% survival in the control group¹.

“The family of mesenchymal stem cells in general possess dual anti-inflammatory and regenerative properties, which make them a promising therapeutic for lung conditions. Based on published, and our independent studies, the JadiCell appears to be superior to other stem cells both in suppressing cytokine storm and activating endogenous pulmonary repair mechanisms,” said Dr. Thomas Ichim, Board Member of TSOI. “Having advanced to the pivotal trial stage of the drug development process we are proud to work with an organization that in our opinion is second to none in terms of quality, expertise and rapid execution”.

JadiCells™ have been shown to possess therapeutic activity in animal models of pulmonary fibrosis and COPD. The Company plans to concurrently develop additional pulmonary indications in addition to COVID-19.

“We are enthusiastic to leverage our expertise in the area of cell therapy and COVID-19 with Therapeutic Solutions International,” said Marc M. Gas, PhD, Associate Director, Program Development, Biorasi LLC. “Having performed numerous registration trials, we are unique in accelerating trial recruitment and being responsive to situations as they arise in real-time. We look forward to working with Timothy Dixon and his team in addressing this fundamentally unmet medical need.”

“Having run stem cell clinical trials, we understand that these types of investigations are characterized by numerous subtleties and peculiarities. We fully appreciate the strengths of Biorasi and are eager to initiate this collaboration, which if successful will result in the first stem cell drug for lung regeneration,” said Timothy Dixon, President, and CEO of TSOI. “Because of Biorasi we have been able to expand upon the original multi-site USA trial into a multi-nation trial and have added India as one of two countries with the other likely to be selected from Latin America,” added Mr. Dixon.

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 https://therapeuticsolutionsint.com, and our public forum is https://forum.therapeuticsolutionsint.com.

About Biorasi, LLC

Our passion is finding efficient, timely and quality solutions for our partners’ most challenging programs. The process of disruption that we began long ago is still ongoing — we are never finished. Today, we are still a nontraditional, unconventional CRO that proudly claims to be the fastest, most responsive global CRO in the industry. The Company's corporate website is https://biorasi.com

1. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial

View source version on businesswire.com: https://www.businesswire.com/news/home/20220328005440/en/

Timothy G. Dixon ir@tsoimail.com

 

Source: Therapeutic Solutions International

FAQ

What is the purpose of the TSOI clinical trial?

The TSOI clinical trial aims to assess the efficacy of JadiCell™ Adult Stem Cell Product in treating patients with advanced COVID-19.

What were the results of the previous TSOI COVID-19 trial?

The previous trial reported a 100% survival rate for patients under 85 years and a 91% survival rate across all ages.

When is the TSOI clinical trial expected to take place?

The TSOI clinical trial has been cleared by the FDA and is set to begin soon with Biorasi overseeing the process.

What are the implications of the JadiCell™ trial for the stock symbol TSOI?

Successful outcomes in the JadiCell™ trial could position TSOI as a leader in stem cell therapies for lung regeneration, potentially boosting stock performance.