Therapeutic Solutions International Seeks to Expand JadiCell Treatment to Broader ARDS Population

Therapeutic Solutions International has submitted an investigational new drug (IND) application to the FDA with the intention of initiating a new phase 3 clinical trial to evaluate JadiCell, an investigational mesenchymal stem cell product licensed by Therapeutic Solutions International, for the treatment of acute respiratory distress syndrome (ARDS).¹ 

While JadiCell is already under evaluation for the treatment of COVID-19 associated ARDS in an ongoing phase 3 clinical trial, the company’s newly submitted IND, if cleared, will open the possibility of evaluating JadiCell for the treatment of the broader population of patients with ARDS, including those with ARDS not associated with COVID-19.^1,2 The company’s decision to pursue further investigation of JadiCell for the treatment of ARDS is based in part on positive data from an earlier phase 1/2a clinical trial that evaluated JadiCell in patients with COVID-19 associated ARDS, results from which were published in Stem Cells Translational Medicine in 2021.^1,3 The results included the finding that patients treated with JadiCell in combination with standard of care (SOC) treatment achieved significantly improved survival compared to patients who received SOC treatment alone (91% vs 42%, P = .015) and time to recovery (P = .03). In terms of safety, no serious adverse events associated with infusion of JadiCell were reported. In addition to these encouraging results, the company also cited the US Patent Trial and Appeal Board’s recent decision to uphold the validity of a patent related to JadiCell as a factor in its decision. 

“The company has stayed a steady course in accomplishing its milestones of in-licensing an advanced cell therapeutic product, filing additional patents surrounding it, demonstrating in animal models and various clinical situations benefits of the product, and now taking the next step in product development by filing for entry into the ARDS patient population, which presents a significantly greater market than COVID-19 induced ARDS,” James Veltmeyer, the chief medical officer of Therapeutic Solutions International and founder of the Veltmeyer Institute for Advanced Therapeutics, said in a statement.¹

According to the company, JadiCell is composed of mesenchymal stem cells derived from umbilical cords which have been “supercharged” with the intention of providing elevated levels of therapeutic factors in comparison to other stem cells.^4,5 Therapeutic Solutions International licensed the cell product from Jadi Cell LLC for the treatment of chronic traumatic encephalopathy and traumatic brain injury in December 2018. In addition to the previously mentioned clinical trials, the company received an emergency IND number and “May Proceed Notification” from the FDA to treat patients with advanced COVID-19 ARDS outside of clinical trials in July 2022.⁶ Late last year, the company also announced that JadiCell may have impacted the conditions of 3 patients with amyotrophic lateral sclerosis (ALS), schizophrenia, and autism, respectively, treated in a collaboration between the company and the Veltmeyer Institute for Advanced Therapeutics.⁷

“We are happy to report the decision of our medical advisors to support entry of our adult stem cell based product into the greater patient population of ARDS,” Timothy Dixon, the president and CEO of Therapeutic Solutions International, added to the statement.¹ “We have numerous physicians eager to join the new trial, including ones who have previously witnessed significant patient improvement in previous clinical uses of our cells.”

REFERENCES

1. Therapeutic Solutions International files to initiate phase III clinical trial for acute respiratory distress syndrome (ARDS) leveraging positive COVID-19 data with Jadicell stem cell therapy. News release. Therapeutic Solutions International. April 20, 2023. Accessed April 21, 2023. https://therapeuticsolutionsint.com/therapeutic-solutions-international-files-to-initiate-phase-iii-clinical-trial-for-acute-respiratory-distress-syndrome-ards-leveraging-positive-covid-19-data-with-jadicell-stem-cell-therapy/ 

2. Therapeutic Solutions International identifies CD103 expressing dendritic cells and exosomes thereof as novel mechanism for JadiCell mesenchymal stem cell mediated lung protection. News release. Therapeutic Solutions International. October 3, 2022. Accessed April 21, 2023. https://therapeuticsolutionsint.com/therapeutic-solutions-international-identifies-cd103-expressing-dendritic-cells-and-exosomes-thereof-as-novel-mechanism-for-jadicell-mesenchymal-stem-cell-mediated-lung-protection/

3. Lanzoni G, Linetsky E, Correa D, et al. Umbilical cord mesenchymal stem cells for COVID-19 acute respiratory distress syndrome: A double-blind, phase 1/2a, randomized controlled trial. Stem Cells Translational Medicine. 2021;10(5):660-673. doi: 10.1002/sctm.20-0472

4. JadiCell stem cells licensed by Therapeutic Solutions International for brain injury significantly increased survival of COVID-19 patients in double blind FDA clinical trial. News release. Therapeutic Solutions International. October 28, 2020. Accessed April 21, 2023. https://therapeuticsolutionsint.com/jadicell-stem-cells-licensed-by-therapeutic-solutions-international-for-brain-injury-significantly-increased-survival-of-covid-19-patients-in-double-blind-fda-clinical-trial/

5. Therapeutic Solutions International signs agreement for licensing Jadicell’s universal donor adult stem cell product for chronic traumatic encephalopathy and traumatic brain injury. News release. Therapeutic Solutions International. December 10, 2018. Accessed April 21, 2023. https://therapeuticsolutionsint.com/therapeutic-solutions-international-signs-agreement-for-licensing-jadicells-universal-donor-adult-stem-cell-product-for-chronic-traumatic-encephalopathy-and-traumatic-brain-injury/

6. Therapeutic Solutions International granted emergency IND by FDA for expanded patient access to JadiCell™ universal donor stem cell for COVID-19 ARDS outside of ongoing phase III clinical trial. News release. Therapeutic Solutions International. July 18, 2022. Accessed April 21, 2023. https://therapeuticsolutionsint.com/therapeutic-solutions-international-granted-emergency-ind-by-fda-for-expanded-patient-access-to-jadicell-universal-donor-stem-cell-for-covid-19-ards-outside-of-ongoing-phase-iii-clinical-tria/

7. Therapeutic Solutions International announces improvements in autism, amyotrophic lateral sclerosis and schizophrenia cases treated by VeltmeyerInstitute for Advanced Therapeutics. News release. Therapeutic Solutions International. December 5, 2022. Accessed April 21, 2023. https://www.businesswire.com/news/home/20221205005372/en/Therapeutic-Solutions-International-Announces-Improvements-in-Autism-Amyotrophic-Lateral-Sclerosis-and-Schizophrenia-Cases-Treated-by-Veltmeyer-Institute-for-Advanced-Therapeutics