Japan has spent more than a decade building one of the safest environments in the world for regenerative medicine. Every treatment plan at Rakan Clinic Tokyo is filed under the Act on Regenerative Medicine (ARM) and reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA).
Regulation Under the Act on Regenerative Medicine
Autologous mesenchymal stem cell infusions fall under Class II of the ARM. Providers must submit detailed protocols describing cell sourcing, culture methods, dosing, and post-treatment monitoring. Approval is granted only after external ethical review and Ministry of Health, Labour and Welfare confirmation.
Class II Regenerative Medicine Plan Certification
Our clinic renews its Class II plan annually, submitting data on patient outcomes, adverse event surveillance, and protocol refinements. This mandatory reporting keeps therapies transparent and accountable.
CPC/CPF Facility Requirement and Inspections
Stem cells must be processed inside a licensed Cell Processing Center (CPC) or Cell Processing Facility (CPF). Inspectors audit sterility logs, air-quality reports, and chain-of-custody documentation. Rakan Clinic operates an in-house CPC inside Azabudai Hills, ensuring cells never leave our controlled environment.
Autologous Stem Cell Safety Advantages
Japan prioritises autologous (self-derived) cells, which eliminates donor rejection risk and aligns with PMDA guidance on personalised medicine. Culturing with the patient’s own plasma preserves compatibility and reduces allergens.
Why International Patients Choose Japan
Patients value the combination of rigorous oversight, partnerships with universities such as the University of Tokyo, and discreet hospitality within Azabudai Hills. For related insights, read “Understanding Stem Cell Therapy Cost” and “Stem Cell Therapy Recovery Time.”
Schedule a consultation for CPC-certified stem cell therapy in Tokyo to review your eligibility, personalised timeline, and travel logistics.
Frequently Asked Questions
How is stem cell therapy regulated in Japan?
The Act on Regenerative Medicine and PMDA oversight require clinics to submit Class I–III plans, undergo independent ethical review, and report outcomes to the Ministry of Health, Labour and Welfare.
What is a Class II regenerative medicine plan?
Class II covers autologous stem cell therapies. Clinics must document safety protocols, physician credentials, and follow-up schedules before approval.
How long do stem cell therapy results last?
Most patients maintain benefits for 12–36 months, particularly when following booster schedules and rehabilitation guidance.
Does the procedure hurt?
Fat collection may cause mild soreness for a day or two, while the infusion itself is typically painless.
How many sessions will I need?
We generally start with one session and recommend boosters every four months, adjusted to your diagnosis and response.
Ready to Learn More?
Schedule a consultation with our specialists to discuss how stem cell therapy can help you. Learn whether adipose stem cells are right for your joint condition.
