What should you ask before you decide to receive cell therapy?

The following questions help you understand from various aspects the treatment that you may receive.

The treatment
  • Is the treatment established for this specific disease or condition?
  • Is the treatment part of a formal clinical trial?
  • If it is not a conventional treatment, is it a recognised alternative for the disease or condition?
  • If I have this treatment, could it affect whether I get into another clinical trial or am able to have another treatment?
  • What are the possible benefits I can expect after receiving this treatment? How long will this take and how can I measure these benefits?
  • Do I still need other medications or special care?
  • Details of stem cell therapy procedure:
    • Where do the stem cells come from?
    • What method does the personnel or institution providing the treatment use to identify, isolate and grow these stem cells?
    • Are the cells differentiated into specialised cells before therapy?
    • How are the cells delivered to the right part of the body?
    • After stem cell transplant, how will my immune system be prevented from reacting to these foreign cells?
 
Scientific evidence and oversight
  • What is the scientific evidence that this new treatment regimen could work for my disease or condition? Where is this evidence published?
  • Has this new regimen undergone clinical trials? What was the conclusion?
  • Is there any independent oversight of the treatment plan, for example, by an Institutional Review Board or similar institution?
  • Is there any independent oversight or accreditation by relevant institutions on the premises where the treatment will be done and the facility where the cells are processed?
  • Is this treatment for this specific disease approved by a national or regional regulatory agency with well-established legislative system, such as HK Department of Health, the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA)?
 
Safety and emergencies
  • What are the risks of the procedure itself, potential or immediate side effects and long-term effect on health?
  • What are the risks that I have to bear in receiving the treatment?
  • What will be done if an adverse effect develops? Who is the person to contact in an emergency or injury? Where can I obtain emergency medical care?
  • Does the clinic have adequate preparation to handle emergencies such as a serious allergic reaction?
  • What follow-up treatment would I receive, and for how long?
  • Who is the doctor in charge of the treatment? Has this doctor received relevant specialised training? How well trained is the technical support staff?
 
Patient rights (for participants in clinical trial)
  • What are my rights as a participant? For example, confidentiality, my right to be informed, my right to withdraw from the treatment process, etc.
  • Will I receive compensation if I am injured as a result of taking part in this study?
 
Cost
  • What are the costs of the treatment? What do the costs include? Do I need to pay for other costs?
  • What would be the costs of emergency treatment if something goes wrong? Who would provide the treatment and who would pay for this?