Therapeutic Solutions International Files for Orphan Drug Designation Using JadiCell Adult Universal Donor Stem Cells for Treatment of Acute Respiratory Distress Syndrome

By: Therapeutic Solutions International via Business Wire

June 26, 2023 at 09:00 AM EDT

Clinical Stage Biotech Company Leverages Existing Clinical Data and Phase III Clearance to Accelerate Treatment of Fatal Lung Condition

Therapeutic Solutions International (TSOI) announced today filing with the FDA for Orphan Drug Designation for its JadiCell Adult Stem Cell Product for treatment of Acute Respiratory Distress Syndrome (ARDS). The Company has been advancing clinical use of this novel umbilical cord derived mesenchymal stem cell in the area of neurology and pulmonology with an FDA cleared clinical trial for COVID-19 associated ARDS.

“Having personally witnessed the potent therapeutic effects of JadiCells as part of Emergency INDs and Right to Try exemptions, I feel it is important for us as a Company to be leveraging the various mechanisms provided by the FDA to fast forward access of this promising cellular drug to patients,” said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International.

Granting of Orphan Drug Designation would qualify JadiCells for certain benefits and incentives, including seven years of marketing exclusivity, tax credits for clinical trials, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application fees.

“We are thankful for the positive feedback we have been receiving from Key Opinion Leaders in the area of regenerative medicine and pulmonology which prompted us to pursue the Orphan Drug Designation for specific aspects of ARDS,” said Timothy Dixon, President, and CEO of the Company. “Given the high mortality rate of this condition, which in some cases is as high as 60%, we are eager to work with the FDA to bring our potential treatment as quickly as possible to patients in need.”

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.