Cell therapy weekly: Regulators approve autologous stem cell therapy for spinal cord injury in Japanese first
This week: New larger-scale closed-system hMSC bank will enable rapid scale-up and Aldevron announces availability of standardized plasmids for gene therapy.
The news highlights:
Japanese regulators approve autologous stem cell therapy for spinal cord injury
New larger-scale closed-system hMSC bank will enable rapid scale-up
Aldevron announces availability of standardized plasmids for gene therapy
Japanese regulators approve autologous stem cell therapy for spinal cord injury
An autologous mesenchymal stem cell (MSC)-based therapy for the treatment of spinal cord injury, developed by NIPRO Corporation (Osaka, Japan), has been conditionally approved for clinical treatment following a 13-patient trial. Stemirac, produced from bone marrow-derived MSCs, is believed to reduce inflammation and protect existing neurons, and should be administered within 40 days of injury.
This approval has already faced a backlash from the regenerative medicine community, citing concerns over the trial design, lack of evidence and ethics of charging for an ‘unproven’ therapy but the developers are hopeful. “The most important point is that the efficacy is dramatic and definitive,” commented Masanori Fukushima, head of the Translational Research Informatics Center (Kobe, Japan) that has been advising on the project for over a decade, speaking to Nature.
Read more (in Japanese)
New larger-scale closed-system hMSC bank will enable rapid scale-up
RoosterBio Inc. (MD, USA) have released RoosterBankâ„¢-hBM-100M-XF, a large-scale working cell bank in a single-use format. The closed-system xeno-free product, which contains 100 million bone marrow-derived human mesenchymal stem cells (hMSCs), will allow the production of batch sizes of more than 20 billion cells.
Founder & Chief Product Officer, Jon A. Rowley commented, “Our goal at RoosterBio is to simplify the scale-up of hMSC manufacturing processes, compress development timelines, and accelerate speed to market. Today’s technology programs and tomorrow’s Regenerative Medicine products require scalable lot sizes of high-quality cells to quickly move through clinical development.”
Aldevron announces availability of standardized plasmids for gene therapy
Aldevron (ND, USA) will make available standardized plasmids for lentiviral production through a license agreement with Oxford Genetics (Oxford, UK). Royalty free, custom Rev, VSV-G, GagPol and expression plasmids will be available for pre-clinical and clinical development as well as commercial manufacture.
“Genetic medicine has experienced tremendous growth with the approval of multiple products that dramatically improve life,” said Michael Chambers, Aldevron’s CEO. “Lentiviral vectors are the key component for manufacturing many of these treatments. The free availability of lentiviral packaging plasmids will significantly reduce the time and cost to develop and commercialize these products.”
For more weekly cell therapy news, read previous editions of the cell therapy weekly.