What should I ask before considering an unproven stem cell “treatment?”

You should ask many questions about the unproven stem cell “treatment” being offered and seek a second opinion from a trusted, qualified physician or medical expert with sufficient knowledge about stem cells and clinical research. You should not be rushed or financially enticed to make a decision—make sure you understand the entire treatment plan and any potential associated risks.

The physicians involved should specialize in your disease or condition, describe other treatment options, and discuss all of the risks that you will take on by receiving a procedure that has not been proven safe or effective. You should be provided with an Informed Consent Form or Treatment Consent Form that should address many of your questions. You should receive a consent form for any unproven stem cell “treatment,” even if it is not part of a clinical trial. It should emphasize the unproven nature of the treatment and outline the specific risks associated with the stem cell treatment(s). This form should be signed by you (or your legal representative) and the person providing the information. You should receive a copy of this form.

Following are recommended questions to ask when considering an unproven stem cell “treatment”:

The “Treatment”

• Is the “treatment” routine for this specific disease or condition?

• 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 or exclude me from other potential treatments?

• 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 does this fit in with my long-term treatment plan?

• How is this stem cell “treatment” done?

• 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 “treatment”?

• How are the cells delivered to the correct 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 current scientific evidence from preliminary tests using this “treatment?” Has this clinic conducted preclinical studies or clinical trials on this product themselves? What were the results? If not, why not?

• Is there any independent oversight of the treatment plan? Can you provide several names of scientists and clinicians who can give independent advice?

• Is there any independent oversight or accreditation of the clinic where the “treatment” will be done and the facility where the cells are processed? If so, is this oversight or accreditation credible? Should I rely on it in any way when making decisions about my health and health care?

• Is there approval from a national or regional regulatory agency, such as the EMA, FDA, PDMA, or TGA, of this treatment for this specific disease or condition?

Safety And Emergencies

• What are the risks of the procedure itself, and the possible side effects both immediate and long-term?

• What will be done if an adverse reaction (bad side effect) develops? Who is the person to contact in an emergency or treatment-related injury? Who will provide emergency medical care? What do I do if I cannot get in touch with someone from the clinic in the event of an emergency?

• 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?

Patient Rights

• 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 receiving this “treatment?” What will I need to do to obtain this compensation? Will I have to go to court and sue?

Cost

• Are there any costs to treatment? If so, what does this include? What other costs will I incur?

• What would be the costs of emergency treatment if something goes wrong?

• Who would provide emergency care and who would pay for this?

• What happens if there is a serious complication that results in long-term disability? Who is responsible for paying associated costs?

• If I have to go to court and seek remedies through litigation, who is responsible for paying legal fees?

• Before traveling or agreeing to treatment, find out what costs your travel insurance, health insurance provider, or national health program will cover, in what circumstances, and in what countries.

• How can I get pre-approval from my insurer or health plan and take steps to avoid receiving unexpected and unwanted medical bills?