Clinical trial success for stem cell-based treatment of spinal cord injury

Written by Alice Philipson

Nipro and Sapporo Medical University now look towards commercialization after reporting success in their recent stem cell therapy trial for the treatment of spinal cord injury.

Medical equipment maker Nipro has announced plans to commercialize a stem cell-based treatment for spinal cord injury developed with Sapporo Medical University (both Osaka, Japan). Their clinical trial, which ended in October 2016, demonstrated stem cells harvested from bone marrow, expanded in vitro and returned to the patient, concentrated in injured areas of the spinal cord and regenerated tissue. Patients who have lost the use of their limbs to spinal cord injury currently have limited functional recovery.

The clinical trial launched in 2014 and ended in October 2016; during this time, approximately 30 patients between the ages of 20 and 64 years old underwent autologous stem cell therapy to treat an injury in the cervical cord. Specifically, bone marrow fluid was collected from the patients within two weeks of injury and mesenchymal stem cells were extracted and cultivated in large quantities. The preparation was then injected intravenously into the patient within 54 days of the injury.

The study demonstrated that administered stem cells accumulated in the injured areas of the spinal cord and led to tissue regeneration. Following the results of the trial, Nipro now plans to apply to the Ministry of Health, Labor and Welfare to register the treatment as a regenerative medicine product.

Despite this success, there are still challenges to be overcome before the treatment is widely available. For example, with the current manual procedures, technicians can grow enough stem cells to treat just 100 patients annually. In Japan, 200,000 people currently suffer from spinal cord injury which increases by around 5000 people each year. Nipro is therefore developing new automated technology for production and testing of stem cell therapies.  Furthermore, Nipro aims to expand the potential of this treatment with similar trials taking place for stroke patients.