Stem cell therapies are a hot topic. From the many ‘cures’ and therapies advertised, to the stories you hear or read, it is reasonable to accept that stem cells are the latest miracle technology. There is no denying that stem cells have opened up new frontiers in medicine and biology because of their potential to restore, repair, replace and regenerate cells. However, most stem cell treatments for both medical and cosmetic procedures have a long way to go before they are mainstream.

Why stem cells are valuable

Stem cells have two defining characteristics which make them valuable: their capacity to self-renew by division; and their capacity to differentiate, giving rise to specialised cells. To use a simple analogy, these specialised cells may be thought of as blank cells that have the ability to adapt into different types of tissue and organs. These characteristics make stem cells a potentially versatile tool in treating various diseases and conditions.

Research into stem cells and their applications provide insight into human development, assist in the study of diseases and in the discovery of potential treatments in regenerative medicine.

The goal of regenerative medicine is to replace dead cells with healthy ones. Research is ongoing on the potential use of adult, embryonic and fetal stem cells as a source for specialised cell types such as blood, muscle, nerve and skin cells, for the treatment of a variety of conditions. In theory, anything that involves tissue degeneration—spinal cord injury, Type 1 diabetes, Parkinson’s disease, heart disease, liver diseases, muscular dystrophies and retinal degeneration, to mention just a few—are candidates for stem cell treatments.

For this reason, a random web search on ‘stem cell therapies’ will produce a long list of conditions potentially treatable with stem cells. The list is limitless right now and includes many uses of stem cells for both medical and cosmetic purposes.

Are stem cell therapies in use today?

Yes. There are many potential therapies going through the experimental phase at present; and a few conditions for which stem cell therapies have been approved as providing safe and effective treatment.

According to the International Society for Stem Cell Research (ISSCR)—an organisation advocating and educating the public and professionals in stem cell research and applications—there are only a few proven forms of stem cell therapy in application right now including:

• Transplanting bone marrow to treat sickle cell anemia, leukemia and certain metabolic conditions.
• Using skin progenitor cells in the treatment of burns.
• Treating injuries of the cornea using limbal stem cells obtained from the cornea itself.

Two clinical trials were approved in 2010 for the use of embryonic stem cells to treat spinal cord injuries and a certain type of blindness, but other than those, and any other clinical trials approved since then, there are currently no therapies using embryonic stem cells.

In their FAQ Section the ISSCR website notes that aside from the therapies mentioned above, the “use of cell therapies remains at an experimental stage and has not been shown to be safe or effective”.

So what about other stem cell applications?

For the most part, stem cell treatments are based upon experimental findings. Supporting data for many of these treatments come from relatively small numbers of patients. Most are based on studies with limited scope, and with limited available samples, consequently resulting in insufficient data to gain wide acceptance in the scientific and research communities. Such results are inadequate to attract approval from agencies like the US Food and Drug Administration (FDA) or the Australian Therapeutic Goods Administration (TGA).

The process for converting experimental applications to mainstream acceptance is, firstly to obtain approval for clinical trials, then to complete the trials and finally, to publish trial findings in peer-reviewed journals. Once the data from clinical trials appear valid and replicable on a larger scale, the researchers can seek approval from regulatory agencies such as the TGA. Once approved, the application may be offered commercially, for consumer and medical use.

One such application that was recently approved by the Australian TGA is for using stem cell enriched fat injections for breast augmentation, breast reconstruction in cancer patients and for breast augmentation following the removal of silicone breast implants. The stem cell enriched fat from a person’s own body, known as autologous adipose-derived regenerative cells or ADRC, and minimally processed can also be used in facial augmentation. You can read more about it in our article, Stem Cells and Cosmetic Surgery.

Unapproved stem cell therapies

On its website, in a page titled FDA Warns About Stem Cell Claims, the FDA expresses concerns “The hope that patients have for cures not yet available may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful”.

Despite such concerns, consumers around the world are frequently offered experimental stem cell treatments that often make incredible claims and cost exorbitant amounts. Consumers should be wary of such claims because if a stem cell treatment is proven to be safe and effective in the long term, it would achieve approval from the appropriate authorities soon enough.

How can unapproved treatments be legal?

While the use of stem cell treatments is highly regulated under both the US FDA and the Australian TGA, there are exceptions that allow many of the experimental treatments to be conducted within the law. Special cases warrant doctors the use of stem cells taken from patients for those patients’ own treatments, subject to minimal processing, for limited treatments and often within a limited time.

Stem cells used in most cosmetic therapies and in other unapproved medical therapies are usually those harvested from the patient’s own body. These cells originate in bone marrow, blood and the spinal cord. They may also come from fat cells (autologous fat) found in excessive fat layers in the body. For example, fat deposits removed by liposuction are particularly rich in stem cells and can be used in various treatments.

Stem cells from other sources may also be used in such treatments, but with special permission required for clinical trials and similar exceptional circumstances.

In this context, using your own stem cells for limited types of treatment is perfectly within the law. Whether these therapies are actually safe and effective is another question entirely.

If you are considering cosmetic stem cell procedures, it is important you ascertain all the facts before proceeding.

Do people benefit from experimental therapies?

Yes, many people may benefit from experimental treatments. Some others may not. There is also bound to be a group of people who will benefit from any type of treatment, regardless of its effectiveness, due to what is known as the “placebo effect”.

Whether a specific stem cell therapy works can only be judged by the evidence obtained at completed clinical trials whose results have been published in peer-reviewed journals as scientifically acceptable, safe and effective.

If you decide to embark on experimental therapies, your best chance for safety lies in reading clinical trials because they are performed under strict supervision by the authorities. Anything that can go wrong needs to be disclosed openly, and such results cannot be hidden.

Stem cells and fat grafting

In mid 2011, a joint task force of the two leading plastic surgery associations in the US, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS) together released a position statement on the use of stem cells in aesthetic surgery.

The statement was based on a systematic evaluation of peer-reviewed literature concerning stem cells and fat grafting. The task force, led by plastic surgeon J. Peter Rubin, MD, of the University of Pittsburgh, a noted expert on fat-derived stem cells, was convened to address the growing concerns in the community over unsubstantiated clinical practices and advertising claims concerning the use of stem cells.

The task force concluded, “while there is tremendous potential for the future use of stem cells in aesthetic surgical procedures, the scientific evidence and other data is very limited in terms of assessing the safety or efficacy of stem cell therapies in aesthetic medicine”.

Over time, you can expect many cosmetic procedures that are in the experimental stages to prove their effectiveness in clinical trials and to receive approval. The TGA approval for soft tissue augmentation using autologous adipose-derived regenerative cells or ADRC, mentioned above, is such an example.

For your safety

Cosmetic treatments exist to make you look and feel better. They are not performed out of medical necessity or emergency. You should only elect to have cosmetic procedures that have been approved for commercial use. They are the only procedures proven to be sufficiently safe and effective.

Ask your doctor whether the stem cell treatment or therapy proposed has been given TGA approval, or whether it is part of a regulated clinical trial. This is relevant even if the stem cells are your own.

The FDA cautions, “Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.”

According to Stephanie Simek, Ph.D., deputy director of the FDA’s Office of Cellular, Tissue and Gene Therapies, “There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.” This is because cells in a different environment may multiply, form tumors, or may leave the site for which they were intended and migrate elsewhere.

If you find that the therapy you are considering is not part of a clinical trial, and is being offered just like any other approved procedure but is not yet approved, we urge you to reconsider having the treatment. Your other options include delaying the procedure until its effectiveness and safety have been established (and it has been approved), or seeking safer alternatives.

Also, be wary of off-label applications. Examples of off-label applications are those products or procedures approved for one specific purpose (and they are always approved in this way) but are being used for an entirely different location on the body or face or for an entirely different type of treatment from the one approved.

You can reduce unnecessary risks of unknown and unproven stem cell therapies by selecting an accredited surgeon and using approved therapies known to be safe and effective.

For more information on stem cell therapies…

• You can find more information on stem cell research and therapies in the Patient Handbook on Stem Cell Therapies issued by the International Society for Stem Cell Research (ISSCR).
• You may also want to check out the website, A Closer Look at Stem Cell Treatments