Not every procedure offered under the name “stem cell treatment” has the same scientific and legal status. The nature of the product used, the disease for which it is applied, the authorizations of the production and application centers, and any license or research permit must each be examined separately. A patient’s signature does not complete a missing authorization, and an authorized procedure does not create a guarantee of success. In Türkiye, the assessment must take into account the Regulation on Products Obtained from Human Tissues and Cells of September 4, 2025, and the rules specific to the procedure concerned. [1]
To frame the legal question correctly, there must be a concrete answer to “which stem cells?” and “for what purpose?” The price of the treatment, the name of a foreign institution or advanced-technology claims cannot replace this information.
How are established treatment, clinical research and treatment trials distinguished?
Stem cells and cell-based products can be used in different medical fields and by different methods. Some applications have an established framework for specific indications, while the same claim for another disease may still be at the research stage. Success in one field cannot be presented as legal or scientific approval for another disease.
The 2025 Regulation on Products Obtained from Human Tissues and Cells and on Centers Related to These Products governs activities ranging from the collection of tissues and cells to their clinical use. Because the Regulation leaves certain centers and activities outside its scope, other regulations must also be identified for special areas, such as the licensing of hematopoietic stem cell transplant centers. It cannot be said that all stem cell applications are authorized in the same way under a single regulation. [K1, Art. 2]
Participation in a clinical study must not be presented like an ordinary sales contract promising success to the patient. The purpose of the study, its uncertainties, the permits and the participant’s rights must be explained. A treatment trial also does not become exempt from all oversight because it is said that “there is no other option.” The legal regime relied upon must be documented.
Why are the product and the center’s authorizations asked about separately?
A single institutional certificate does not authorize every procedure
The 2025 Regulation separates the functions of tissue and cell sourcing, processing and production, storage and distribution, and application to humans. A health institution’s general license, or a laboratory’s operation, does not show that every product may be applied to every patient. The scope of the authorization with respect to the product and the medical indication is important. [K1, Art. 5, 23–25]
The patient or their representative may request answers to the following questions:
- What is the exact name, source and method of preparation of the product to be applied?
- In which institutions will production and application take place?
- What is the product’s license or special authorization route?
- Do the authorization and permit extend to the patient’s diagnosis and the method to be applied?
- If the procedure is research, how are the ethics committee and competent authority processes documented?
- Who is responsible for post-application follow-up and reporting of adverse events?
Requesting documents does not mean that the same authorization document will exist for all patients. Special provisions may apply to unlicensed products used within a research or treatment trial. However, such an exception cannot be interpreted as meaning that the product is open to ordinary commercial circulation and free use. [K1, Art. 23/9, 25]
What do “autologous,” minimally manipulated or “natural” product mean?
The fact that a product is obtained from the patient’s own body does not remove the legal requirements. The Regulation distinguishes between autologous use, the degree of processing and homologous use. The nature of the product may affect the quality, production, authorization and clinical use conditions to which it is subject. A “natural” or “personalized” claim in marketing text is not a legal classification. [K1, Art. 4]
The method used during processing, the function for which the product is provided and its systemic effect may change the assessment. For a legal opinion, therefore, not only the invoice but also the relevant sections of the technical product file and the application record may be needed. Where the patient cannot access these directly, obtaining them through the competent authority or a court may be considered.
How are the scientific basis and the treatment promise assessed?
The existence of a study does not show that a treatment is accepted for every patient or guarantees success. The claim presented to the patient must match the stage of the research, the patient group and its results. Presenting animal experiments or a limited number of observations as established clinical success may undermine the information provided.
In legal review, the promised result and the service actually undertaken are determined. Claims such as “definitive cure,” “full recovery without surgery” or “guaranteed success” are made concrete through web pages, messages, videos and recorded conversations. A general “success is not guaranteed” statement signed later does not automatically cancel all the effects of an earlier misleading presentation. [2] [3] [4] [5]
A health institution may argue that the uncertainty was clearly explained to the patient and that it acted within a scientific framework. This defense must be supported by the information given to the patient, the indication for the procedure, the authorization status and the treatment plan. Legal assessment must rely on the relevant expert review rather than personal opinion about the medical effectiveness.
On promotional claims and misleading advertising, see our article on misleading advertising and treatment promises in medical tourism.
The specific scope of informed consent
A consent form that merely states “stem cells will be applied” may not be sufficient. The source, the stages of the procedure, the limits of the expected benefit, the uncertainties, the significant risks, the alternatives and the follow-up obligation must be explained in a way the patient can understand. If a separate tissue collection procedure will be performed, its risks are also taken into account. [2]
In clinical research, voluntary participation, the conditions for withdrawal and treatment options outside the study are also important. Whether leaving the study may result in arbitrary cessation of medically necessary care, or be tied to an undisclosed financial penalty, is assessed separately. Who bears research costs, such as product costs, routine care and travel, must be clarified together with the applicable research rules; no single rule can be set that a fee may or may not be charged in every case.
If the patient is a minor, decision-making capacity and conditions of legal representation require special review. The child’s best interest, available treatment options and the specific conditions for participation in research are important regardless of a parent’s signature. A family’s difficult situation in the face of promising promotions does not reduce the duty to inform.
On consent, see also our article on whether a consent form removes the doctor’s liability.
Which records are used to examine product safety and traceability?
The 2025 Regulation provides detailed obligations regarding quality management, records and traceability. It must be possible to trace from whom, in which center and when the product was obtained, and how it was processed, transported and applied. The application center’s patient-specific risk–benefit assessment and the reporting of adverse events after application are important. [K1, Art. 25, 27–34]
| Review area | Required record example | Legal significance |
|---|---|---|
| Product identity | Code, batch and source information | Matching the product to the patient |
| Production and transport | Processing, storage and delivery records | Assessing the safety chain |
| Clinical decision | Diagnosis, indication and risk–benefit assessment | Justification for patient selection |
| Application and follow-up | Procedure note, checks and adverse event record | Timing and management of harm |
Not every document may exist under the same name in every procedure. The records to be requested are determined by the nature of the specific product and the authorization route. If something is missing, the reason why the information could not be obtained must be clearly recorded.
Are failure, treatment error and breach of authorization the same?
The failure of an expected improvement to occur is not, by itself, proof of fault. On the other hand, unauthorized use, failure to carry out a patient-specific assessment, an unsuitable product, inadequate follow-up or a misleading promise may each constitute separate grounds of liability. For each of these, the breach, the damage and causation are examined separately. [3]
For example, suppose a patient paid a fee on the strength of a promised improvement, but the service provided differed from what was described. Even if no bodily harm occurred, a breach of contract and a claim for the fee may be arguable. In another case, the product’s being contrary to the authorization conditions may not show that all the health problems that developed were directly caused by that product. A medical link between the breach of authorization and bodily harm may need to be established. These examples are not actual case files or case summaries.
The natural course of the patient’s existing condition is also taken into account. The court-appointed expert must compare the condition before and after the procedure, concurrent treatments and alternative explanations. The institution’s defense that “the disease was already severe” must also be tested against the records.
For similar procedures, see our article on patient rights in PRP, mesotherapy and ozone procedures; for proof, see our article on how medical malpractice is proven.
Fees, re-treatment costs and compensation claims
Claims for a refund of fees or for defective service under the contract are separate from compensation for bodily harm that has arisen. Necessary additional treatment, care, loss of income and non-pecuniary damage may be claimed depending on the circumstances of the event. The same expense cannot be recovered twice under different names. [3] [4]
The roles of the company that received payment, the institution that performed the procedure, the physician and other actors involved with the product must be determined. The fact that a product was brought from abroad or that an intermediary was involved does not automatically mean that all persons bear liability on the same legal basis. If there is a foreign element, the applicable law, jurisdiction, service of process and enforcement of the judgment are examined separately.
The patient should keep the contract, the invoice, authorization statements, the documents provided as scientific support and promotional records. The authority of the institution or the product may be investigated before the Provincial Health Directorate (İl Sağlık Müdürlüğü) and the competent Ministry units. The jurisdiction and time-limit rules for an inspection application and for a compensation lawsuit must not be confused.
To calculate the components of a claim, see our article on how medical malpractice compensation is calculated; for our service page, see medical malpractice and physician error lawsuits.
Conclusion
In stem cell procedures, legal protection depends less on the name of the treatment than on establishing its actual nature. The product, the indication and the center’s authorizations must be assessed together with the information provided, the scientific basis and the follow-up records. Giving the patient hope does not remove the duties to explain uncertainties and to obtain the necessary authorizations.
Frequently Asked Questions
Does the use of my own cells mean that no authorization is required?
No. Autologous use is an important classification; however, the preparation method of the product, its purpose of use and the applicable authorization regime are still examined.
Does ethics committee approval prove that the treatment is definitely successful?
No. An ethical review or research permit is not a guarantee of efficacy or outcome for every patient. The subject and scope of the permit must be read separately.
Can a product approved in a foreign country be freely applied in Türkiye?
Foreign approval does not automatically replace the permits required in Türkiye. The product, how it was brought in, the application center and the indication are checked together.
Is a fee refund always available when there is no improvement?
The absence of a result may not be sufficient on its own. The contract, the promise made, the suitability of the service and the information provided are assessed together.
Can a right be pursued without a specific precedent decision on the matter?
Yes. A claim can be built on applicable legislation and concrete evidence. Unverified decision references, or decisions concerning different procedures, must not be used as though they guarantee a definitive outcome.
Sources and legal bases
- Regulation on Products Obtained from Human Tissues and Cells and on Centers Related to These Products (İnsan Doku ve Hücrelerinden Elde Edilen Ürünler ve Bu Ürünler ile İlgili Merkezler Hakkında Yönetmelik), Official Gazette (Resmî Gazete), September 4, 2025, No. 33007; especially Arts. 2, 4–5, 23–25, 27–34. Full text published by the Ministry of Health.
- Patient Rights Regulation (Hasta Hakları Yönetmeliği), Arts. 15–18, 24, 26, 32 et seq. Ministry text.
- Law No. 6098, Turkish Code of Obligations (Türk Borçlar Kanunu), Arts. 49–56, 112, 115, 502 et seq. Official legislation.
- Law No. 6502 on Consumer Protection (Tüketicinin Korunması Hakkında Kanun), Arts. 5, 13–16, 61–62, 73–73/A. Official legislation.
- Regulation on Promotion and Information Activities in Health Services (Sağlık Hizmetlerinde Tanıtım ve Bilgilendirme Faaliyetleri Hakkında Yönetmelik), Official Gazette (Resmî Gazete), November 12, 2025, No. 33075, Art. 5. Ministry text.