There is certain information you should look into if you are considering a stem cell treatment, including a detailed description of the treatment and the science that supports it, the expected outcome and the risks.
In many cases, particularly in a clinical trial, you should be provided with a patient information sheet and informed consent documents that answer many of the questions below. However, don’t hesitate to ask for more information or further explanation. The medical team involved should know a lot about your disease or condition, other treatment options, and the evidence that the treatment they are offering will be safe and that it will work.
The questions and answers are best discussed with a trusted physician familiar with your condition who can help you understand the treatment and your choices. It is a good idea to seek medical advice independent of the provider to help assess whether the treatment and outcome claims offered are reasonable.
- Is the treatment routine for this specific disease or condition?
- Is the treatment part of a formal clinical trial? Learn more about things to consider with clinical trials here.
- What are the alternative treatment options for my disease or condition?
- If I have this treatment, could it affect whether I get into a clinical trial in the future?
- What are the possible benefits I can expect? How will this be measured and how long will this take?
- What other medications or special care might I need?
- How is this stem cell procedure done? Consider these nine things to know about stem cell treatments.
- What is the source of the stem cells?
- How are the stem cells identified, isolated and grown?
- Are the cells differentiated into specialized cells before therapy?
- How are the cells delivered to the right part of the body?
- If the cells are not my own, how will my immune system be prevented from reacting to the transplanted cells?
Scientific evidence and oversight
- What is the scientific evidence that this new procedure could work for my disease or condition? Where is this published?
- Have there been (earlier) clinical trials? What was learned from these trials?
- Is there independent oversight of the treatment plan by an ethics committee?
- Is there any independent oversight or accreditation of the clinic where the treatment will be done and the facility where the cells are processed?
- Is there approval from a national or regional regulatory agency, such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) or Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), for this treatment of this specific disease?
Safety and emergencies
- What are the risks of the procedure itself, and the possible side effects both immediate and long-term?
- Are there any other risks to me in joining in the study?
- What will be done if an adverse reaction (bad side-effect) develops? Who is the person to contact in an emergency or research-related injury? Who will provide emergency medical care?
- Is the clinic adequately prepared to handle emergencies such as a serious allergic reaction?
- What follow-up treatment will be received, and for how long? What will I need to do?
- Who is the doctor in charge of the treatment? What specialized training does this doctor have? How well trained are the other doctors and the technical support staff?
- How many people have been treated for my disease or condition at your clinic? Of those, how many have gotten better? How many haven’t? Have your findings been published?
- What are my rights as a participant—for example confidentiality, my right to be informed of any new information that might come up, my right to withdraw from the treatment process?
- What compensation am I entitled to if I am injured as a result of taking part in this study?
In a clinical trial, typically the cost of the test treatment and trial monitoring is covered by the company developing the product or by local or national government funding. Learn more here.
- What are the costs of the treatment? What does this include? What other costs will I incur?
- What would the costs of emergency treatment be if something goes wrong? Who would provide and pay for this? Before traveling or agreeing to treatment, find out what costs your health insurance provider, national health program or travel insurance will cover, in what circumstances and in what countries.