ELK CITY, Idaho–(BUSINESS WIRE)–Therapeutic Solutions International announced today granting of Emergency IND # 28685 and a “May Proceed Notification” from the Food and Drug Administration (FDA) for the treatment of advanced COVID-19 ARDS outside of the currently ongoing Double Blind Placebo Controlled Phase III clinical trial for the same indication. The Company previously announced treatment of 15 “no option patients” under both “eIND” and “Right to Try” Law1.
“Based on my clinical experience with the JadiCells, their therapeutic effects are unparalleled in comparison to any other stem cell therapy,” said Dr. James Veltmeyer, Chief Medical Officer of Therapeutic Solutions International. “With the increase in COVID-19 cases, as well as the anticipated deluge of COVID-19 ‘long hauler’ patients, it is imperative that we have mechanisms to provide these cells to patients who desperately need them, even if it is outside of the clinical trial. Our number one mission as a Company is to accelerate development of these cells as rapidly as possible and to save people’s lives.”
Previously the Company has demonstrated superior activity of JadiCells to other stem cells, as well as identifying mechanisms of action2,3. The JadiCell is currently in Phase III for COVID-19 ARDS4, has been granted IND numbers for COPD5, and Chronic Traumatic Encephalopathy6, and is in late preclinical development for Idiopathic Pulmonary Fibrosis7.
“We are thankful for the brave doctors that approach us and work with us to provide accelerated access to potentially life-saving cell therapies such as JadiCells to their patients,” said Timothy Dixon, President, and CEO of Therapeutic Solutions International. “We are blessed to have very positive relations with the FDA which has allowed for rapid movement through the various regulatory hurdles involved in development and commercialization of stem cell therapies.”
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.
1 Therapeutic Solutions International Successfully Treats “No Option” Patients with its JadiCell™ Stem Cell Therapy While Advancing Preparations for Phase III COVID-19 Clinical Trial (yahoo.com)
2 Therapeutic Solutions International Identifies and Files Patent on Novel Mechanism of Action of Its FDA Phase III Cleared JadiCell™ Treatment of COVID-19 and Delta Variant (prnewswire.com)
3 Therapeutic Solutions International Identifies Novel Biological Pathway Utilized by its Phase III Adult Stem Cell Product JadiCell™ to Stimulate Healing of Injured Lung Tissue | Business Wire
4 Therapeutic Solutions International Announces Launching of Phase III Clinical Trial for Treating COVID-19 Lung Damage Using its JadiCell™ Universal Donor Stem Cell Drug | BioSpace
5 Review of TSOI’s COPD Therapy Moves Forward With IND Designation (copdnewstoday.com)
6 Therapeutic Solutions International Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using Clinically Validated JadiCell® Universal Donor Stem Cell (prnewswire.com)
7 Therapeutic Solutions International Develops Novel Stem Cell Based Therapy to Reduce Lung Scarring: Potential Solution to Post COVID-19 Lung Deterioration (prnewswire.com)