Therapeutic Solutions International Announces Initiation of JadiCell™ Manufacturing Program to Address Upcoming FDA Phase III Trial and Emergency Use Requests
Therapeutic Solutions International, Inc. (OTC Markets: TSOI) has initiated pilot batch production of JadiCells, its FDA-cleared umbilical cord stem cell product, set to enter Phase III clinical trials for COVID-19. The company successfully reproduced manufacturing protocols under US patent #9,803,176 B2 for various indications. This milestone aims to reduce production costs and enhance accessibility for healthcare providers. Enhanced internal manufacturing aligns with the anticipated demand driven by the Right to Try Law and Emergency Use Authorization.
- Initiation of pilot batch production for JadiCells.
- FDA clearance for Phase III clinical trials for COVID-19.
- Successful reproduction of manufacturing protocols, which may lower production costs.
- Filing of new patents for novel manufacturing procedures.
- None.
ELK CITY, Idaho, Oct. 11, 2021 /PRNewswire/ -- Therapeutic Solutions International, Inc., (OTC Markets: TSOI) announced today initiation of pilot batch production of JadiCells, its umbilical cord stem cell product cleared by the FDA to enter Phase III clinical trials for COVID-19.
Company scientists have successfully reproduced manufacturing protocols described in the issued US patent # 9,803,176 B2 which is exclusively licensed for pulmonary indications, chronic traumatic encephalopathy, and traumatic brain injury. Additionally, the Company has filed an extensive patent covering novel manufacturing procedures as well as "second generation" JadiCells.
"Seeing myself as a man of science, the fact that we have successfully reproduced in our own hands the isolation and scalable generation of JadiCells, according to the protocols used in previously published clinical trials, is a fundamental milestone" said Dr. Thomas Ichim, Board Member of the Company, and co-inventor of the manufacturing patent. "As we prepare to launch the Phase III clinical trial in COVID-19 we need to ensure that manufacturing procedures utilized are practical and economical. The data generated by the team, as well as the various advancements that we have filed intellectual property on significantly reduce the cost of production."
Cellular therapies are characterized by extremely high costs and need for complicated procedures during manufacturing, transportation, and administration. Therapeutic Solutions International aims to increase the practicality and reduce barriers to entry for physicians wishing to utilize this "living medicine" in their patients.
"Due to the enormous interest in utilizing JadiCells domestically under the Right to Try Law and domestically and internationally under Emergency Use Authorization, as well as our upcoming Phase III clinical trial, we have decided as a Company to initiate internal manufacturing" said Timothy Dixon, President and CEO of the Company and co-inventor of the patent. "I am thankful for the efforts of our team in developing and validating the numerous Standard Operating Procedures associated with cell manufacturing, as well their innovations which have led to, in my opinion, an unparalleled patent being filed."
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/
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