Therapeutic Solutions International Receives FDA Clearance to Initiate Phase III Pivotal Registration Trial for JadiCell™ Universal Donor COVID-19 Therapy
Adult Stem Cell Therapy Previously Demonstrated to Block Inflammation While Regenerating Injured Tissue to Enter Final Phase of Testing
| Source: Therapeutic Solutions International, Inc.
ELK CITY, Idaho, Aug. 5, 2021 /PRNewswire/ — Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today clearance from the Food and Drug Administration (FDA) to initiate a Phase III pivotal trial for registration of the Company’s JadiCell™ universal donor stem cell as a treatment for COVID-19 associated lung failure.
In previous studies the Company has demonstrated the superior activity of JadiCell™ to other types of stem cells including bone marrow, adipose, cord blood, and placenta. Furthermore, the JadiCell™ was shown to be 100% effective in saving the lives of COVID-19 patients under the age of 85 in a double-blind placebo controlled clinical trial with patients in the ICU on a ventilator. In patients over the age of 85 the survival rate was 91%1.
“We are thankful for the strong regulatory, basic research and translational team that has worked in successfully obtaining this FDA clearance,” said Dr. Thomas E. Ichim, Director of the Company. “FDA clearance to initiate a Phase III clinical trial means we are at the last phase of development before commercially selling the product. This positions us in a highly exclusive place in that to our knowledge no other cells have this potent ability to concurrently suppress inflammation while restoring function of tissue damaged by SAR-CoV-2.”
“Having personally seen the effects of JadiCells on patients, I have seen their clinical potential firsthand” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “I am very excited to enter the final step of clinical development before being able to provide these cells to the general population.”
“Despite the initial promise of vaccine approaches, there exists a significant portion of the population refusing them and there are also patients in whom vaccines have failed to induce appropriate immunity. Once COVID-19 initiates its pathological cascade leading to lung failure, no therapies exist until now to address this population” said Famela Ramos, Vice President of Business Development. “We are looking forward to leveraging the current clearance not only for obtaining market registration but also for expanding into other COVID-19 related pathologies.”
“Today marks a significant milestone in the growth of our Company as we have received the final regulatory clearance before final marketing approval,” stated Timothy Dixon, President and CEO of Therapeutic Solutions International. “Successful completion of the agreed upon trial with the FDA will position the Company as a significant force in the global battle against this unseen enemy that to date has caused over 4.25 million deaths. We are extremely proud of our progress and vow to accelerate our work for humanity and for our shareholders.”
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 – Lanzoni – 2021 – STEM CELLS Translational Medicine – Wiley Online Library