A health ministry panel has given a conditional green light to the commercialization of a regenerative medicine to treat those with spinal cord injuries.
Given the decision Tuesday, the health minister is expected to allow the production and sale of the preparation made from human mesenchymal stem cells and related apparatus by the end of the year, people familiar with the matter said.
In June this year, medical equipment-maker Nipro Corp. applied for approval of the commercialization of the preparation and related equipment the company jointly developed with professor Osamu Honmo at Sapporo Medical University.
In the treatment, mesenchymal stem cells taken out of bone marrow fluid from patients with spinal cord injuries roughly within a month of them becoming injured will be cultured to make the preparation, which will then be injected back into the patients whose stem cells were used.
The treatment, personally tailored for each patient, will be sold under the Stemirac brand.
The cells are expected to restore damaged nerve cells and improve symptoms, such as paralysis of the arms and legs.
The safety of the medicine was confirmed through a clinical trial. But because it stopped short of fully demonstrating its efficacy, the panel recommended that the minister make a formal decision on whether to approve the product after examining data collected from 90 patients who had received the medicine.
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