Regulators approve autologous stem cell therapy for spinal cord injury in Japanese first
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.
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.
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