TOKYO -- A Ministry of Health, Labor and Welfare expert panel has decided to seek the approval of the minister for the commercialization of a stem cell product designed to treat spinal cord injuries and regenerate motor and sensory functions of patients under certain conditions.
Minister Takumi Nemoto is expected to approve the product by the end of this year at the earliest. If approved, it would be the first such move in the world to approve the treatment for crippling injuries, according to the ministry.
The product was developed by Nipro, an Osaka-based pharmaceutical company, and the firm applied for government approval in June. The medication is for patients with spinal injuries who sustained the damage within roughly two weeks before beginning treatment and have lost all or most of their mobility or feeling.
In the treatment, up to 50 milliliters of bone marrow fluid and blood is extracted from the patient, and stem cells in the fluid -- mesenchymal stem cells -- are grown into 50 million to 200 million cells in two to three weeks. The cells are then injected back into the patient through an intravenous drip.
The stem cells are then expected to converge around damaged nerves in the spinal cord, suppress inflammation and release substances that promote the revival of nerve cells and improve the patient's physical functions.
The product includes cultured stem cells and a kit to extract bone marrow fluid. It was jointly developed by Nipro and Sapporo Medical University. The medicine was applied to 13 patients in a clinical test, and 12 of them showed improvement in their conditions -- one or more points on the 5-point scale measuring their functional problems.
The safety of the product has been confirmed, but its effectiveness is still only estimated. The expert panel therefore set the condition for the continued sale of the medication on whether it proves useful in 90 patients over a period of seven years with patient rehabilitation.
As many as 5,000 people are estimated to suffer from spinal cord injuries every year. For their treatment, a Keio University team is promoting a clinical trial plan to use iPS cells, or induced pluripotent stem cells, while a venture company in the United States is pushing for a treatment regimen with embryonic stem cells.
(Japanese original by Suzuko Araki, Science & Environment News Department)