Completion of administration of Stemchymal to all enrolled patients in phase II clinical trial in Japan
24 May 2021
We are pleased to announce that administrations of Stemchymal, a regenerative medicine product derived from somatic stem cells, have been completed to all enrolled patients in phase II clinical trial for the treatment of spinocerebellar ataxia in Japan. The safety and efficacy of Stemchymal will continue to be investigated during a certain observation period.
Spinocerebellar ataxia is a rare and intractable disease. Degeneration of nerve cells in the cerebellum, brainstem, and spinal cord gradually cause various symptoms including difficulties in walking and swallowing and impairment of daily life. Stemchymal is expected to inhibit the disease progression.
In Taiwan, the Phase I/II clinical trial conducted by Steminent Biotherapeutics Inc. indicates the safety and efficacy of Stemchymal. The following Phase II clinical trial was also completed in 2020, showing that no serious safety was observed. The efficacy data is being analyzed.
We will continue the Phase II clinical trial of Stemchymal in Japan on schedule and do our best to obtain the approval as soon as possible so that we can provide the new treatment to patients suffering from the disease.