OCEANSIDE, Calif.--(BUSINESS WIRE)--Therapeutic Solutions International announced today receiving Investigational New Drug application number #28508 from the United States Food and Drug Administration for its proposed clinical trial evaluating the JadiCell™ in treatment of COPD.
The FDA also assigned to the Company a Product name for its investigational biologic now known as “Allogeneic Umbilical Cord Mesenchymal Stem Cells, JadiCell; Intravenous injection”. Additionally, the FDA has already entered into binding discussions with the Company regarding details of the clinical trial and subject population.
“COPD is a devastating disease, which in my opinion, is ripe for stem cell intervention,” said Dr. James Veltmeyer, Chief Medical Officer of the Company. “Based on the striking animal data in COPD models, as well as clinical recoveries in other pulmonary conditions that I have witnessed, I am eager to begin formal clinical investigations of this cell.”
The Company previously reported and filed patents on the therapeutic activity of JadiCell in several models of COPD, as well as the ability of the cell to inhibit several pathological mechanisms associated with the condition.
“We are thankful to the FDA for rapidly initiating the review of our work and we are confident that through this interaction we will create a trial that is beneficial to patients suffering from this condition for which to date, no curative options exist,” said Timothy Dixon, President and CEO of the Company.
Currently the Company is running a Phase III clinical trial to treat lung damage in patients with advanced COVID-19.
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.
