There is certain information you should check 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, especially in a clinical trial, you should receive a patient information sheet and informed consent documents that answer many of the questions below. However, do not hesitate to ask for more information or additional explanations.


The medical team involved should know a great deal about your disease or condition, other treatment options and the evidence that the treatment they are offering is safe and 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 being offered are reasonable.


The treatment

Is this the standard treatment for this specific disease or condition?

Is the treatment part of a formal clinical trial?

What are the alternative treatment options for my disease or condition?

If I undergo this treatment, could it affect my ability to enter a clinical trial in the future?

What are the possible benefits I can expect? How will they be measured and how long will it take?

What other medications or special care might I need?

How is this stem cell procedure performed?

What is the source of the stem cells?

How are the stem cells identified, isolated and cultured?

Are the cells differentiated into specialized cells before the 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 can work for my disease or condition? Where has it been published?


Have there been (previous) clinical trials? What was learned from those 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 performed and of 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 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 immediate and long-term side effects?


Are there other risks to me in joining the study?

What will be done if an adverse reaction (a bad side effect) occurs? 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 severe allergic reactions?


What follow-up treatment will be received and for how long? What do I need to do?

Who is the physician responsible for the treatment? What specialized training does this physician have? How well trained are the other physicians and the technical support staff?

How many people have been treated for my disease or condition at your clinic? Of these, how many improved? How many did not? Have your findings been published?


Patient rights

What are my rights as a participant – for example, confidentiality, my right to be informed of any new information that may arise, 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?


Cost

In a clinical trial, the cost of the treatment and trial monitoring is usually covered by the company developing the product or by local or national government funding.


What are the costs of the treatment? What does it include? What other costs will I incur?

What would the costs of emergency treatment be if something went wrong? Who would provide and pay for it? Before traveling or agreeing to the treatment, find out which costs your health insurance provider, national health program or travel insurance will cover, under what circumstances and in which countries.