REPROCELL completes patient registration for phase II clinical trial of regenerative therapeutic Stemchymal®
25 February 2021
All patients have been registered at ten sites in Japan for the Phase II clinical trial of Stemchymal®, a human adipose-derived stem cell product exclusively licensed in Japan by Steminent Biotherapeutics Inc. (hereinafter referred to as Steminent), where the safety and efficacy of the regenerative therapeutic will be evaluated in patients with spinocerebellar ataxia (SCA).
SCA is a rare neurological disease which has a significant effect on quality of life. It characterized by progressive in-coordination of gait and dysphagia, which is caused by degeneration of neurons in the cerebellum, brain stem, and spinal cord. There is no cure for SCA, and current standard-of-care treatments have limited success in reducing symptoms.
Researchers at REPROCELL hope that Stemchymal® will inhibit disease progression, thereby improving quality of life for patients. Safety and efficacy of the regenerative therapeutic is suggested in small-scale phase I/II clinical trial conducted in Taiwan. The next stage of drug development, phase II trial in more SCA patients with placebo and double-blinded manner, was completed in 2020. It also showed that no serious safety issue is observed and efficacy data is currently been analyzed.
In the United States, Steminent has also received the approval of Phase II clinical trial notification (IND) by FDA. Additionally, Steminent has entered into an exclusive license agreement with SCM Lifescience Co., Ltd in for the clinical development and commercialization of Stemchymal® in Korea.
In Japan, Stemchymal® is classified as a regenerative medicine product for rare diseases. This allows REPROCELL to receive support from government in the form of development subsidies, tax measures, priority review etc. REPROCELL expect the review period to be shorter than usual due to the priority review process, which is excellent news for patients.
REPROCELL will continue to promote this Phase II clinical trial of Stemchymal® in Japan and aim to receive early approval Stemchymal®, so that the therapeutic may reach SCA patients as soon as possible.