As experts, we are frequently asked about stem cells and how they are used in both research and the clinic.
Click on the arrow next to each question and scroll down to the box below to read our response. The information in this section may help you in your research. If you have other questions, contact us for more information.
How can I make sense of the claims made by the clinic?
If a clinic is offering unproven therapies, why is it allowed to operate?
The doctor I found says he is a stem cell expert, how do I know?
How do I know if the product I'm being treated with is approved?
Who should I ask for more information - my GP or my Specialist?
It is important that you don’t just take the word of the clinic looking to sell you something. Do your research. Ask the clinic or doctor lots of questions, visit other websites to find out more.
Remember you will be more likely to find reliable information on websites hosted by universities, research organisations, state and Australian governments and patient support groups. Information on blogs, Facebook or websites of private clinics can be misleading.
Gather up the findings from this research and make an appointment with your current doctor to talk through your options.
You do not have to make this decision on your own.
We have developed a check list of questions to raise with the stem cell clinic you may be considering, together with additional questions to ask your doctor.
Before 2019, it was possible for some Australian stem cell clinics and doctors to offer experimental therapies using a patient's own cells without first testing that what they were selling was safe and effective.
New laws mean that the Australian regulators, the Therapeutic Goods Administration or TGA, now have a greater role in making sure clinics meet required standards. Unproven stem cell treatments should only be available to patients either in hospital, or registered in clinical trials. There is also a ban on advertising unproven stem cell-based therapeutic products. However, some Australian clinics choose to ignore these rules and continue to advertise.
Unfortunately, stem cell clinics in other countries may not be subjected to as rigorous standards and you will need to carefully evaluate any claims they make.
For doctors to be a recognised specialist they need to have completed an extensive training and accreditation program and have the benefit of working for many years in one area of medicine.
In Australia there is a defined list of recognised medical specialties including anaesthesiologists, paediatricians, pathologists, physicians and surgeons. You can visit the Medical Board of Australia to find out more.
There is no such thing as either a ‘Stem Cell Specialist’ or a ‘Regenerative Medicine Specialist’. These are not recognised titles in Australia or elsewhere in the world.
Just because a doctor is working at a stem cell clinic and offering to treat you does not automatically make them an expert in your condition.
Approved therapeutic products will be listed on the Australian Therapeutic Goods Registry (ATGR) so this can be a good place to start.
In Australia, the Therapeutic Goods Administration or TGA approves products made from or containing stem cells, with the exception of the use of bone marrow stem cells to treat certain blood and immune diseases. Approval is based on evidence that the product is safe and effective.
Beyond the TGA, it's a good idea to check in with organisations respected for their advocacy and research on your condition.
For example, the Cancer Council, MS Australia, Dementia Australia, state, territory and national medical and dental boards or councils. These organisations have expert knowledge and strong relationships with hospitals, researchers and clinical trial regulators.
You can also visit the International Society for Cell and Gene Therapy to see a list of cell, tissue and gene products that have been approved in different part of the world. Use the map to find out more information about products and their application.
Both your GP and your specialist will be able to help you navigate through the information you find online and through other sources. Even if they have not heard about the proposed treatment, they will be able to critically review what you have found and discuss its relevance in the context of your condition.
As a general rule, GPs will have a general idea of the trends, but may not know all the specifics of any one area. Specialists have undertaken additional training and have the benefit of working for many years in one area of medicine, so they know a lot about that one area.
If your GP is unsure about the research you’ve gathered yourself, or the therapies in question and what this might mean for your condition, it might be a good idea to ask them to refer you to a relevant specialist who will have more detailed knowledge of your condition and be able to provide advice on your treatment options.
Remember, there is no such thing as a ‘stem cell specialist’ and you should be wary if a doctor claims to hold such a qualification.
If you find a clinical trial that you are interested in joining, please speak to your specialist or treating doctor first. They will be able to go through the trial information with you and can also help determine if you are a good candidate for the trial taking into account your medical history and current stage of disease.
If you are interested in finding out what clinical trials might be underway for your condition, you can use recognised databases such as ANZCTR or clinicaltrials.gov to search for relevant trials. However, you may need to take your research back to your doctor to help you make sense of what you find. Your doctor can also help put you in contact with the team coordinating the clinical trial if it looks like a good fit for you.
Clinical trials are designed to explore whether a possible new drug, device or treatment provides benefit but does not cause harm. Clinical trials are often referred to as being in different phases of evaluation which takes into consideration what doctors and researchers are trying to assess.
For example, early phase clinical trials (Phases I-II) are primarily designed to assess whether the proposed treatment is safe in a small number of people. Phase III studies will test whether the new intervention has benefit in a larger number of patients. This usually involves comparing how patients receiving an experimental treatment respond compared to a control group that receive an existing treatment or a placebo. Phase IV refers to an ongoing evaluation phase once the treatment has been approved to make sure that the new treatment continues to be monitored.
In Australia, clinical trials are required to be reviewed by a Human Research Ethics Committee (HREC) and listed on a clinical trial registry such as the ANZCTR.
Asking for the ethics approval can be another way to check the validity of the trial and its sponsors.
For more information visit the Australian Clinical Trials website.
Participants in clinical trials are not usually required to pay for the treatment they are receiving as part of the trial. If you are asked to contribute financially, or if those running the ‘trial’ accept donations from potential participants, be wary. Ethics committee review would usually flag this as a particular concern and it may be a sign that the ‘trial’ has not been fully evaluated and may not be legitimate.
It is important to continue to support your friend or family member, no matter the decisions they may make regarding their health.
For patients who are researching treatments, encourage them to visit this website for more information. There are also patient resources (Contact other experts) that are available to help people make decisions regarding stem cell treatments.
Also encourage the person you are caring for to continue seeking treatment from their current doctor and to discuss whether stem cells are an appropriate option for them.
Ultimately it is a patient’s choice to decide whether they want to pursue treatment options including stem cell therapy but we are always happy to provide further information if you can’t find what you need on this or other websites. Just get in touch.
Many people decide to travel overseas for stem cell treatments or pay for expensive treatment at an Australian clinic. Often, they will reach out to friends, family and community via crowdfunding platforms to help fund these pursuits. The cost of treatment alone can be significant, without even considering travel, accommodation, after care, and lost wages.
Medical crowdfunding has saved many lives, especially where there is unequal access to healthcare, and where public funding and insurance don't cover costs. However, as is the case with many social media platforms, misinformation on these sites is common.
If you're thinking of donating to a loved one's stem cell treatment crowdfunding campaign, bear in mind that crowdfunding platforms aren't required to screen campaigns at risk of misinforming donors and may inadvertently imply that the treatment being considered has more legitimacy than it has.
You can also consider showing you care by offering to help with practical day-to-day tasks, like cooking, cleaning, or grocery shopping. And no matter their decision, continue to support and offer help.
Stem cell banking involves cryogenically preserving yours or your child’s stem cells for use in the future.
The most common service involves storage of umbilical cord blood. While donating cord blood for use in people diagnosed with diseases of the blood and immune system is a recognised service that has saved lives around the world, routine banking of cord blood for personal or family use is not yet part of mainstream medicine.
More recently, tooth or dental pulp stem cell banks and also banks that collect your skin or blood sample for future use in regenerative medicine have been established.
Although it may seem like storing your baby’s stem cells is like taking out a ‘biological insurance policy’ to bolster your child’s health in the future, it is important to remember that the research into using one’s own cells (autologous treatments) is very much in its infancy. It is important that you consider the likely benefits against the costs and discuss the option with your treating doctor.
If English is not your first language, it can be doubly difficult to get the facts on stem cells. Luckily there is an increasing number of resources available in non-English languages.
Please visit these websites to find resources that may be helpful for you and your family and friends.
National Health and Medical Research Council
Therapeutic Goods Administration
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