Japanese health ministry committee endorses full approval for Stemirac cell therapy for spinal cord injury
Japanese health ministry committee endorses full approval for Stemirac cell therapy for spinal cord injury
On 15 October, an expert committee of Japan’s Ministry of Health, Labour and Welfare endorsed full approval for Stemirac; a formal decision by the minister is expected later. The treatment is prepared from the patient’s own bone marrow cells and administered intravenously after spinal cord injury. Stemirac is the first regenerative medicine product in Japan to progress from conditional approval to a committee recommendation for full approval.
In 2014, Japan introduced conditional approval for regenerative medicine products. This allowed a product to be used for a limited period, with a requirement to collect comparative treatment data and apply for full approval within seven years. Stemirac is now going through this second stage.
Stemirac received conditional approval in December 2018. It was developed by the Japanese company Nipro and Sapporo Medical University. The treatment involves growing cells from the patient’s own bone marrow and administering them intravenously. Yomiuri reports that these cells are thought to suppress inflammation and support nerve growth near the injury site. In its November press release, Nipro reported that it had completed a comparative study and applied for full approval.
The Yomiuri article states that 73 patients received Stemirac and 66 formed the comparison group; 40 treated patients showed improvements in motor function and other measures. The committee noted that patients receiving Stemirac spent more time in rehabilitation. Following full approval, the ministry intends to require Nipro to continue collecting rehabilitation data. The comparison with 66 patients who did not receive the treatment distinguishes the Stemirac analysis from an early case series involving another cell therapy in four people with complete cervical spinal cord injuries: that series reported improvements in movement without a control group, although some function returns spontaneously during the first months after injury.
Since 2015, eight regenerative medicine products have received conditional approval, and the approval periods for two have already expired. Stemirac is the first product for which the committee has endorsed full approval. The ministry also intends to require Nipro to continue collecting rehabilitation data.