Cell therapy weekly: Orphan Drug Designation filed for Frontotemporal Dementia stem cell treatment
This week: An Orphan Drug Designation application was filed with the US FDA for the treatment of Frontotemporal Dementia with JediCell adult stem cells, an agreement was signed providing the Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA (NH, USA) with access to Pluristyx’s (WA, USA) clinical-grade reprogrammed induced pluripotent stem cells (iPSCs) and a grant of US$3 million has been awarded for research into revascularization techniques.
The news highlights:
Orphan Drug Designation filed for Frontotemporal Dementia stem cell treatment
Therapeutic Solutions International (ID, USA) has filed with the US FDA for Orphan Drug Designation of JadiCell adult stem cells for the treatment of Frontotemporal Dementia. This filing follows the company’s reported success in utilizing JadiCells to treat patients with chronic traumatic encephalopathy under the Right to Try Law. Chief Medical Officer of the Company, James Veltmeyer, stated: “Recent in vitro and animal data suggests the possibility of utilizing these cells in Frontotemporal Dementia, which possesses some molecular similarities to CTE.”
“Our new data and the recent findings supporting the possibility of JadiCell-based neural regeneration for Frontotemporal Dementia supports the idea that the JadiCell platform can be leveraged in a variety of disease indications,” said Timothy Dixon, President and CEO of Therapeutic Solutions International. “We are excited that we can begin offering this treatment today based on the established clinical history and safety profile of this immune modulatory cellular therapy.”
JadiCells are also being investigated for use in several pulmonary indications, including acute respiratory distress syndrome and chronic obstructive pulmonary disease.
iPSC manufacturing and commercialization agreement signed between Pluristyx and the Advanced Regenerative Medicine Institute
Pluristyx (WA, USA) and the Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA (NH, USA) have entered into an agreement regarding the manufacturing and commercialization of Pluristyx’s clinical-grade reprogrammed iPSCs. The agreement provides ARMI | BioFabUSA, its affiliates, and members streamlined access to Pluristxy’s iPSCS for cell and gene therapy manufacturing applications.
Pluristyx CEO, Benjamin Fryer, stated: “We are thrilled to expand our relationship with ARMI | BioFabUSA and provide our clinical grade iPSCs to advance the development of tomorrow’s stem cell derived therapies. As long time ARMI | BioFabUSA Members, we look forward to expanding our work to fulfill the organization’s mission of bringing revolutionary products to patients in need.”
US$3 million to improve tissue revascularization techniques
A grant of US$3 million has been awarded by the National Institutes of Health’s National Heart, Lung, and Blood Institute to fund the development of a novel approach to restoring soft tissue with two coordinating revascularization techniques. Amir Sheikhi, assistant professor of chemical engineering and biomedical engineering at Penn State College of Engineering, will lead the four-year grant as principal investigator, alongside co-principal investigator Dino Ravnic, Huck Chair in Regenerative Medicine and Surgical Sciences, associate professor of surgery at the Penn State College of Medicine and an attending plastic surgeon at the Penn State Health Milton S. Hershey Medical Center.
“Tissue revascularization is a bottleneck for regenerative medicine,” said Amir Sheikhi. “This is an important award for the whole field, as we hope to develop a fundamentally new way to tackle the problem using a transdisciplinary team.”