MHLW Approves Biostar’s Autologous Stem Cell Therapy for ASD

Biostar Stem Cell Technology Research Institute has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its “angel stem cell therapy” for autism spectrum disorder (ASD). This regenerative therapy will be available at Osaka Trinity Clinic, a medical center affiliated with Biostar, for individuals aged four or older with an ASD diagnosis.

Here are the key details of the new therapy:

Therapy Method: The treatment utilizes autologous fat-derived mesenchymal stem cells, which means the stem cells are harvested from the patient’s own body fat.

Treatment Protocol: Patients will receive an intravenous administration of 50 million to 300 million stem cells over five to ten sessions, with each session spaced two to four weeks apart.

Evaluation: Three months after the final session, the safety and effectiveness of the treatment will be measured using the Social Responsiveness Scale-2 (SRS-2), a standard diagnostic tool for autism.

Partnerships: Biostar is jointly operated by RBIO and Nature Cell. RBIO is responsible for supplying the stem cells using Nature Cell’s proprietary culture medium, in collaboration with Japan Angel Stem Cell (JASC).

Regulatory Compliance: The therapy is being implemented under Japan’s Safety and Security Act, which ensures high safety standards for regenerative medicine.

Future Plans: Dr. Jeong Chan Ra, director of Biostar, noted that this approval provides patients and families worldwide with access to “Korea’s advanced stem cell technology.” The company also plans to collect and analyze clinical data from these treatments to accelerate the development of new therapeutic applications in the U.S.

The approval marks a significant step in the clinical application of stem cell therapies for neurodevelopmental conditions, with ASD affecting an estimated 61.8 million individuals globally.