Stem Cell Therapy May Have Effect in Patients With ALS, Schizophrenia, and Autism

JadiCells, an investigational mesenchymal stem cell product licensed by Therapeutic Solutions International which is intended to treat various indications, 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 Veltmeyer Institute for Advanced Therapeutics.^1,2

“In patients with neurodegenerative diseases such as ALS, there is a correlation between survival and the number of T-regulatory cells that can actually produce nerve protective growth factors,” James Veltmeyer, chief medical officer, Therapeutic Solutions International, and founder of the Veltmeyer Institute, said in a statement.¹ “In the case of our ALS patient, in addition to physical improvements, an increase in T-regulatory cells after stem cell therapy was observed at an astounding level from 47% pre-treatment to 77% post-JadiCell infusion treatment. Another case we treated was that of a 5.5-year-old boy diagnosed with autism who has literally not spoken a single word since birth. After JadiCell infusion, he is now actually talking for the first time in his life. Treatment of the schizophrenic patient demonstrated some degree of improvement."

JadiCells are 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.^2,3 Therapeutic Solutions International licensed the cell product from Jadi Cell LLC for the treatment of chronic traumatic encephalopathy (CTE) and traumatic brain injury in December 2018. JadiCells are also currently under investigation by Therapeutic Solutions International for the treatment of acute respiratory distress syndrome (ARDS) associated with COVID-19 in a phase 3 clinical trial.⁴ The company received an emergency investigational new drug (IND) number and “May Proceed Notification” from the FDA to treat patients with advanced COVID-19 ARDS outside of the phase 3 trial in July of this year.⁵ 

Additionally, the company has submitted an IND application to the FDA for the evaluation of JadiCells in patients with chronic obstructive pulmonary disease and CTE. Preclinical studies are ongoing for JadiCell for the treatment of idiopathic pulmonary fibrosis.

“We are committed to taking our stem cell therapies through the normal regulatory processes with the FDA,” Timothy Dixon, president, and chief executive officer, Therapeutic Solutions International, added to the statement.¹ “With that being said, as a corporation we have a moral and social responsibility to provide access to promising treatments as fast and ethically as possible. Therefore we are pleased to collaborate with the Veltmeyer Institute to make stem cell therapy affordable and accessible to the vast majority of people needing such treatment. If we can reach this goal, we will have made another gigantic stride toward healing people of some of the most destructive diseases to plague mankind.”

REFERENCES

1. 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. 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 

2. 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. 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/ 

3. 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. 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/ 

4. 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. 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/ 

5. 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. 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/