Biostar Stem Cell Technology Research Institute has received the Japanese Ministry of Health, Labour and Welfare (MHLW) approval for its angel stem cell therapy for autism spectrum disorder (ASD).
Biostar is jointly operated by RBIO and Nature Cell.
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To be available at Osaka Trinity Clinic, a medical centre affiliated with Biostar, individuals aged four or above diagnosed with ASD can receive the regenerative autism therapy, which utilises autologous fat-derived mesenchymal stem cells.
Eligible individuals can expect to undergo between five and ten sessions, where they will receive an intravenous administration of 50 million to 300 million stem cells. These sessions are spaced two to four weeks apart.
Following the final session, an evaluation using the Social Responsiveness Scale-2 (SRS-2), a commonly used diagnostic tool for autism, occurs three months later to measure safety and efficacy.
RBIO is responsible for supplying these vital stem cells using Nature Cell’s culture medium while collaborating with Japan Angel Stem Cell (JASC).
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By GlobalDataASD is a neurodevelopmental condition that affects 61.8 million individuals worldwide, equating to one in every 127 individuals.
Biostar Stem Cell Technology Research Institute director Dr Jeong Chan Ra said: “With the recent approval by Japan’s Ministry of Health, Labour and Welfare, patients and their families worldwide will now have access to Korea’s advanced stem cell technology.
“In addition, we intend to expedite the development of new therapeutic applications in the US by systematically collecting and analysing clinical data before and after treatment.”
The therapy is carried out under the Safety and Security Act of Japan, ensuring high safety standards.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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