This week: An international marketing license for a mesenchymal stem cell (MSC)-based product for the prevention and treatment of graft-versus-host disease (GvHD), and a new technology that de-risks clinical trial and commercial shipments.
The news highlights:
In a Stem Cells publication, researchers from the University of Texas Health Science Center at Houston (UTHealth; TX, USA) detail the results of a landmark Phase I clinical trial investigating the use of autologous, bone marrow-derived cells in the treatment of ischemic stroke. The team employed serial diffusion tensor imaging to capture, for the first time, the repair of motor nerve tracts extending from the brain through the spinal cord in recovering stroke patients, demonstrating the safety and feasibility of the cell-based stroke therapy.
Lead study researcher Sean I. Savitz, Director of the Institute for Stroke and Cerebrovascular Disease (TX, USA) and a neurology professor at the McGovern Medical School at UTHealth, commented: “According to our findings, it is feasible to perform a bone marrow harvest and then infuse the cells in a wide range of stroke patients. Well-designed randomized clinical trials are needed to further assess safety and efficacy of this novel approach to enhance stroke recovery.”
Fujifilm (Tokyo, Japan) has announced its decision to exercise its license concerning CYP-001 — Cynata Therapeutics’ (VIC, Australia) mesenchymal stem cell (MSC)-based therapy for the treatment of graft-versus-host disease (GvHD). The decision grants Fujifilm an international license to market the therapy and follows the successful completion of a Phase I clinical trial investigating the safety and efficacy of CYP-001 in GvHD treatment. Fujifilm will also support the planning and carrying out of Phase II trials concerning the use of CYP-001-related products — CYP-002 and CYP-004 — for the treatment of critical limb ischemia, osteoarthritis and other indications.
Ross Macdonald, CEO of Cynata, stated: “Fujifilm’s decision to exercise its license option in GvHD is a clear validation of our Cymerus platform technology solution for manufacturing MSCs at scale. We now look forward to Fujifilm taking [CYP-001] through further clinical development activities and subsequently to market.”
BioLife Solutions (DC, USA) — suppliers of several, best-in-class cell and gene therapy bioproduction tools — have announced the adoption of their evo® cold chain management system by multiple, new, field-leading customers including Janssen (Beerse, Belgium), Autolus (London, UK) and Adaptimmune (Oxfordshire, UK). The evo system employs novel cloud-connected shippers and evo.is to de-risk clinical trial and commercial shipments.
Mike Rice, CEO of BioLife Solutions, commented: “The evo system includes many significant innovations that can reduce the likelihood of in-transit issues that arise when using outdated competing solutions, including temperature excursions and payload breakage due to mechanical shock. In the emerging pay on response reimbursement paradigm, de-risking the possibility of administering a non-viable dose is critical.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.