In breaking news released earlier this month, Cynata Therapeutics (ASX: CYP) announced a major world first. The company treated a patient with steroid resistant acute graft-versus-host disease (GvHD) as part of a phase 1 clinical study of its first mesenchymal stem cell (MSC) product, CYP-001 .
This is an important value catalyst for Cynata and also for the regenerative medicine industry, because it is the first time ever that a patient has been treated with an allogeneic induced pluripotent stem cell (iPSC)-derived therapeutic mesenchymal stem cell (MSC) product.
The milestone also represents a giant leap forward in the production of MSCs, which is currently expensive, requires multiple extractions from different donors and relies on excessive expansion (division) of the cells to manufacture sufficient product. Cynata’s unique and proprietary Cymerus™ technology provides a completely different approach.
The Phase 1 clinical trial is expected to include a total of 16 patients who will receive two infusions of CYP-001, with a week between doses.
According to Dr. Adrian Bloor, UK Chief Investigator in Cynata’s Phase 1 clinical trial in acute steroid resistant GvHD, the CymerusTM technology platform has the ability to create a stable clinical trial product using induced pluripotent stem cells sourced from a blood donation from a single donor. To date, MSC clinical trials have traditionally struggled with clinical endpoints and demonstrated variable results, because they rely on a massively expanded cellular product and require sourcing from multiple donors.
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