Orphan drug designation sought for stem cell therapy to treat frontotemporal dementia

Therapeutic Solutions International has filed with the FDA to receive orphan drug designation for its JadiCell adult stem cell therapy for treatment of frontotemporal dementia.

According to a company press release, JadiCells inhibit inflammasome activation and downstream chemical messengers of this inflammatory pathway, while also stimulating regeneration of damaged neurons.

Frontotemporal dementia, the leading cause of dementia in patients younger than 60 years, is caused by a buildup of proteins within brain cells, which cause inflammation and activation of immune cells that damage frontal and temporal lobes, the company said. Those affected may develop behavioral changes or primary progressive aphasia.

“We have previously had success in treating patients suffering from chronic traumatic encephalopathy using the JadiCell cell therapy product, administered under the Right to Try Law,” James Veltmeyer, MD, Therapeutic Solutions chief medical officer, said in the release. “Recent in vitro and animal data suggest the possibility of utilizing these cells in frontotemporal dementia, which possesses some molecular similarities to CTE.”