Cell Therapy Q&A
Update Date：2024/12/04，
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What are the Legal Channels for Cell Therapy?
Currently, there are two legal channels for cell therapy in Taiwan:
1. Cell Therapy Technology Programs Approved by the Ministry of Health and Welfare (MOHW): These programs allow medical institutions to perform cell therapy based on specific technical plans authorized by the MOHW.
2. Cell Therapy Clinical Trials Approved by the Taiwan Food and Drug Administration (TFDA): These trials undergo rigorous review and approval by the TFDA to ensure safety and efficacy.
Relevant information about approved cell therapy technologies can be found in the Cell Therapy Technology Information Section and the Taiwan Clinical Trial Information Platform.
It is important to note that cell therapy can only be performed after thorough review and approval by health authorities. Not all medical institutions are authorized to provide cell therapy services!
What Cell Therapy Techniques Approved by the Ministry of Health and Welfare Can Our Hospital Perform?
The cell therapy projects currently approved by the Ministry of Health and Welfare for our hospital include:
1. Autologous Immune Cell (CIK) Therapy:
o For patients with malignant hematologic tumors unresponsive to standard treatment.
o For patients with stage IV solid tumors.
o For patients with stage I to III solid tumors unresponsive to standard treatment.
2. Autologous Immune Cell (DC) Therapy:
o For patients with stage IV solid tumors.
3. Autologous Adipose-Derived Stem Cell Therapy:
o For chronic wounds or wounds unhealed for more than six weeks.
o For degenerative joint diseases, including osteoarthritis and knee cartilage defects.
4. Autologous Chondrocyte Therapy:
o For knee cartilage defects.
Note:
The suitability of cell therapy varies depending on individual health conditions and medical history. It is not universally applicable to all patients. Therefore, it is essential to consult with a professional physician to ensure the most appropriate treatment recommendations.
Doctor, I Have Osteoarthritis—What Treatment Options Can Help?
Currently, various treatment options are available, such as hyaluronic acid injections. However, these treatments cannot restore the function of damaged cartilage. According to published studies, some patients who received cell therapy showed improvement in cartilage damage as observed through MRI follow-ups, and their symptoms were alleviated in certain cases.
My Wound Has Been Treated for Years, I Have Tried Many Dressings and Treatments, and Visited Several Hospitals, but It Still Won't Heal—What Should I Do?
Currently, there are various treatment options available, such as hyaluronic acid injections. However, these treatments cannot restore the function of damaged cartilage. Nevertheless, according to published research, some patients who received cell therapy showed improvement in cartilage damage as observed through MRI follow-ups, and their symptoms were alleviated in certain cases.
Is Cell Therapy Covered by National Health Insurance? Will It Be Expensive?
Currently, cell therapy is not included in the National Health Insurance coverage, so it must be paid out-of-pocket. You can visit the "Cell Therapy Technology Information" section on the Ministry of Health and Welfare website to find relevant information about medical institutions offering cell therapy. You can also refer to the medical fee standards disclosed by the health bureaus of municipal and county (city) governments for detailed cost information.
Why Are the Costs of Cell Therapy in Taiwan Higher?
The higher costs of cell therapy in Taiwan are primarily due to factors such as high technology and equipment costs, training and salary expenses for specialized personnel, strict regulations and clinical trial requirements, individualized treatment processes, and a smaller market size that prevents cost reductions in production. Additionally, certain technologies may require the payment of patent fees, all of which contribute to the higher charges.
The Current Status of Exosome Applications in Taiwan
Most exosome therapies are still in the clinical trial phase and have not received approval from the Taiwanese authorities for medical use. As such, they are prohibited for use in intravenous injection, intradermal injection, and subcutaneous injection. The safety and efficacy of exosome technology still require long-term validation.
Currently, exosomes are primarily applied in the cosmetics industry, where regulations are relatively lax compared to medical applications. In March 2023, Taiwan conditionally approved the use of human-derived exosomes as cosmetic ingredients, making it the fifth country after the United States, Canada, Japan, and South Korea to allow the use of human exosomes in cosmetics.
It’s important to note that exosomes are not cells themselves but products secreted by cells. As such, they are not currently regulated under the "Regulation of Medical Devices for Specific Medical Techniques" (Special Medical Device Act). Furthermore, there are no dedicated legal frameworks specifically addressing exosomes at this stage. Future regulations will be clarified once detailed provisions under Taiwan's "Regenerative Medicine Dual Law" are announced.