Therapeutic Solutions International Engages Venvalo Group to Oversee JadiCell COVID-19 Phase III Clinical Trial and Emergency Use Authorization (EUA) Process
| Source: Therapeutic Solutions International, Inc.
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 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 group.
“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/
1 Umbilical cord mesenchymal stem cells for COVID–19 acute respiratory distress syndrome: A double–blind, phase 1/2a, randomized controlled trial