Hello, I am Dr. Hidenori Shimada of Grand Green Osaka Umekita Clinic in Osaka, Japan.
When people research regenerative medicine, most of the attention goes to what a treatment might do. A thoughtful decision also requires looking at the other side: what could go wrong, how likely it is, and how a clinic prepares for it. This article is written for international patients and residents of Japan who are considering adipose-derived stem cell therapy at Grand Green Osaka Umekita Clinic or any similar provider. It is general information, not medical advice, and it cannot replace a consultation with a physician.
The short answer: every medical procedure carries risk
No medical treatment is free of risk, and stem cell therapy is no exception. Using your own cells (an autologous approach) may lower the chance of rejection or allergic-type reactions compared with donor cells or artificial materials, but it does not remove risk entirely. Risks can come from several steps: the fat collection, the laboratory culture of the cells, and the intravenous infusion itself. The right question is not whether a treatment has risks, but whether the clinic can explain them clearly and whether you are comfortable with that explanation.
Where risks can arise in the treatment process
In this treatment, a very small amount of fat tissue is collected through a small incision under local anesthesia. Mesenchymal stem cells are then cultured and expanded at a specialized facility, and later returned to the body by IV infusion. Each stage has its own points worth discussing with your doctor.
- Fat collection: As with any minor procedure under local anesthesia, bruising, soreness, bleeding, infection at the collection site, or a reaction to the anesthetic are possible.
- Cell culture: Cells are grown outside the body, so contamination control, quality testing and traceability are important topics to ask about.
- IV infusion: Reactions during or after infusion, such as fever, chills, or discomfort at the injection site, have been described in the medical literature on mesenchymal stem cell infusions. Your doctor can explain what is known and what is still uncertain.
Published studies of mesenchymal stem cell infusions generally report that serious adverse events were uncommon in the trials reviewed. However, these studies vary widely in design, cell source, dose and patient population, and long-term follow-up data remain limited. For that reason, results from one study should not be generalized to every patient or every clinic.
Why your own health history matters
Individual factors can change how a treatment is judged. A history of cancer, blood-clotting problems, active infection, autoimmune conditions, pregnancy, allergies, or the use of blood-thinning medication may affect whether this therapy is appropriate for you. This is one reason the consultation comes first. A physician needs to review your records, medications and current condition before any decision is made, and in some cases the right answer may be that the treatment is not suitable.
If you are traveling from overseas, bring a summary of your diagnoses, recent test results, a list of medications and, if possible, a letter from your home doctor. Having your regular physician aware of your plans also helps with follow-up once you return home.
What Japan’s regulatory framework does and does not tell you
In Japan, regenerative medicine is provided under the Act on the Safety of Regenerative Medicine, which requires providers to submit a treatment plan to the authorities after review by a certified committee, and to use cell processing facilities that meet defined standards. Adipose-derived stem cell therapy at Grand Green Osaka Umekita Clinic is offered as a self-pay treatment, meaning it is not covered by national health insurance.
It is important to understand what this framework means. A submitted and accepted plan indicates that a clinic operates within a legal system for oversight. It is not a guarantee of any outcome, and it does not mean a treatment is approved as a drug or standard therapy for a specific disease. Because the therapy is self-pay, you should also ask how follow-up visits, complications and any additional care are handled and billed.
Questions worth bringing to your consultation
Preparing questions in advance helps you use consultation time well, especially if you need an interpreter or are working across time zones. Consider asking the following.
- What are the known and possible side effects at each step, and how are they monitored?
- Which patients are advised not to receive this treatment?
- Where are the cells cultured, and how is quality checked before infusion?
- What happens if I develop symptoms after returning to my home country?
- What are the total costs, the number of visits required and the expected time in Japan?
- What is the evidence for my specific condition, and what remains uncertain?
A clinic that welcomes these questions and answers them plainly is generally easier to trust than one that offers only promises. Be cautious about any provider that guarantees results, dismisses concerns or discourages you from consulting your own doctor.
Making an informed decision as an international patient
Regenerative medicine is an active field, and responses to treatment differ from person to person. Stem cell therapy is not a replacement for standard medical care, and it should be considered alongside the options your current physician recommends. Taking time to compare information, review the consent documents carefully and ask for explanations in a language you fully understand are all reasonable steps.
Grand Green Osaka Umekita Clinic in Osaka provides information for international patients, including a foreigner-friendly page with multilingual guidance, so you can review the basic flow and fees before deciding whether to book a consultation. Final decisions about suitability, risks, side effects and costs are made together with the treating physician after an examination. If you are unsure, it is always acceptable to gather more information first and to decide not to proceed.
- Ask about risksEach step has its own points
- Share your historyRecords and medications
- Know the frameworkSelf-pay, plan under Japanese law
- Decide with your doctorAfter an examination
This diagram is a conceptual summary of the article content
References
- PubMed: Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]). (2017)
- PubMed: Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells for Parkinson's Disease: A Randomized Trial. (2025)
- PubMed: Safety and efficacy of umbilical cord tissue-derived mesenchymal stem cells in the treatment of patients with aging frailty: a phase I/II randomized, double-blind, placebo-controlled study. (2024)
- PubMed: Glycocalyx-edited mesenchymal stem/stromal cell therapy in advanced osteoporosis. (2026)
- PubMed: Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese adults with type 2 diabetes: a single-center, double-blinded, randomized, placebo-controlled phase II trial. (2022)
- PMC: A prospective single-arm study on the effects of repeated intravenous infusions of canine adipose-derived mesenchymal stromal cells in dogs with chronic inflammatory enteropathy. (2025)
- PMC: Evaluation of Multiple Intravenous Infusions of Autologous Adipose-Derived Mesenchymal Stem Cells in Parkinson's Disease: A Randomized, Double-Blind Clinical Trial. (2026)
- PMC: Safety of multiple intravenous infusions of adipose-derived mesenchymal stem cells for hospitalized cases of COVID-19: a randomized controlled trial. (2023)
- MHLW (Japan): Regenerative Medicine — Ministry of Health, Labour and Welfare, Japan
Supervising Physician
Director, Medical Corporation Shimada Clinic
Head of Clinical Practice, Grand Green Osaka Umekita Clinic
Hidenori Shimada
Graduated from the University of Tokushima Faculty of Medicine in 2005. After his initial residency, he obtained U.S. medical certification (ECFMG) and trained as a sub-intern in general surgery at the University of Washington. After completing the doctoral program at Kyoto University Graduate School of Medicine and working as a researcher at the Center for iPS Cell Research and Application (CiRA), Kyoto University, he founded Shimada Clinic in 2013. At Grand Green Osaka Umekita Clinic (https://umekitaclinic.org), he is engaged in a wide range of care, from internal medicine and pediatrics to cell therapy and aesthetic medicine.
* The physician supervision of this article covers its academic content only and does not constitute a recommendation of any specific treatment or product.