HUNS001

Key development product HUNS001

‘HUNS001’ is a stem cell product designed to treat chronic stroke occurring six months after the onset of a stroke.

Why We Focus on Autologous Stem Cells?

Previous clinical trials of stem cell therapies for stroke in Japan have targeted the acute (within days) and subacute (within weeks) phases, using allogeneic cells (stem cells from donors) due to their cost-effectiveness through mass culture, though they cannot sustain long-term engraftment in the brain but may reduce inflammation. Unfortunately, many of these products could not achieve satisfactory recovery. Conversely, we focus on autologous stem cells (stem cells harvested from the patient’s own body). These cells avoid immune rejection and can sustain long-term engraftment, making it feasible to restore neural network functions in the chronic phase where inflammation has subsided. Previous proto-type HUNS001 clinical study confirmed that our stem cell can engrafted in patients’ brains for over five years. Given the lengthy process of nerve regeneration (several months to over a year), prolonged engraftment is crucial for maximizing therapeutic effects in the chronic phase.

Automated Culture Technology

Using autologous stem cells poses challenges such as high costs, time-consuming processes, lack of economies of scale, and significant financial burden on patients. To address these issues, we have developed complete automated culture technologies. Transitioning to fully automated, closed system culture devices reduces infection risks, lowers technical requirements, and makes cell culture more efficient and consistent. It also enables easier design and space-saving of cell culture facilities, facilitating scalability and significantly reducing manufacturing costs.

Supply System via Central CPC

Patients will have bone marrow harvested at local hospitals (A), transported to a central CPC (B) for cell culture, and processed into products within 3-4 weeks. These products are then distributed to local CPCs (C) for final preparation and same-day delivery to related hospitals for transplantation. By establishing a network of university hospitals with local CPCs, regional core hospitals, and comprehensive stroke centers, we aim to overcome the challenges of limited facility expansion post-approval.