Therapeutic Solutions International Engages Venvalo Group to Oversee JadiCell COVID-19 Phase III Clinical Trial and Emergency Use Authorization (EUA) Process
Therapeutic Solutions International (TSOI) announced on September 10, 2021, the engagement of Venvalo Group to manage regulatory and strategic aspects of its FDA-cleared Phase III clinical trial for JadiCells, aimed at treating advanced COVID-19. Principal Investigator Dr. Camillo Ricordi praised the collaboration, citing prior successful trials with a 100% survival rate for patients under 85. CEO Timothy Dixon expressed excitement about leveraging expertise for effective clinical translation and developing an Emergency Use Application.
- FDA clearance for Phase III clinical trial of JadiCells for COVID-19.
- Successful previous trial led by Dr. Ricordi showing 100% survival in patients under 85 years old.
- Engagement with Venvalo Group for enhanced regulatory support and strategic execution.
- None.
ELK CITY, Idaho, Sept. 10, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today the engagement of Venvalo Group to assist the Company on regulatory, strategic, and implementation aspects of the recently FDA-cleared Phase III clinical trial assessing ability of JadiCells to treat patients with advanced COVID-19.
"I have known Dr. Boris Reznik for many years and have seen first-hand his ability to rapidly grow companies and perform clinical trials in a variety of disease indications including COVID-19," said Dr. Camillo Ricordi, Principal Investigator of the initial clinical trial, whose promising results resulted in the current FDA approval to proceed with a multi-site, Phase III trial. "Being in the middle of the biggest biological threat that our generation has witnessed, I believe it is imperative to work with top quality groups to rapidly complete this trial and bring this new treatment to patients as quickly as possible."
In 2020 Dr. Ricordi led the international team that successfully completed the first FDA approved controlled trial to treat the most severe cases of COVID-19 with stem cell infusions1. The unprecedented results allowed for
"The work of Dr. Ricordi has significantly impacted the field of medicine in areas of Type 1 Diabetes, regenerative medicine, and transplant immunology," stated Dr. Boris Reznik, Chairman of Venvalo Group. "We are proud to work with this Medical Visionary and to perform the most rapid and effective clinical translation of this novel and life-saving technology as soon as we can."
"By leveraging the knowledge gained from the hundreds of clinical trials performed by Dr. Reznik at bioRASI, as well as the unsurpassed innovative abilities of Dr. Ricordi, we are excited to rapidly move forward with the current clinical trial, as well as the Emergency Use Application, which is currently under development," said Timothy Dixon, President and CEO of Therapeutic Solutions International.
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 original content:SOURCE Therapeutic Solutions International
FAQ
What is the purpose of the Phase III trial for JadiCells by Therapeutic Solutions International?
What were the results of previous trials conducted by Dr. Camillo Ricordi?
Who is overseeing the JadiCells Phase III trial for Therapeutic Solutions International?
What is Therapeutic Solutions International's next step following the FDA clearance?
What stock symbol is associated with Therapeutic Solutions International?
