Stem cell treatments and regulation - a quick guide for consumers

6 April 2016
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stem cells

Our bodies are made up of about 200 different types of cells, such as muscle cells, skin cells and nerve cells. Each cell type specialises in performing a certain function. Stem cells are cells that are not specialised. Their role is to replace specialised cells that have been lost through injury, diseases, or the normal course of events.

The science of stem cells is an exciting area of ongoing medical research with great potential. Medical research into stem cells is still at the very early stages. Our understanding of the risks associated with stem cell treatment is limited. Further research is required to create safe and effective treatments.

In Australia, the only proven safe and effective stem cell treatment is haematopoietic stem cell transplantation (using stem cells from umbilical cord blood or bone marrow) for the treatment of disorders of the blood and immune system such as leukaemia.

Currently, no other stem cell treatment has been demonstrated to be safe and effective. However, some clinics located both in Australia and overseas offer unproven stem cell treatments.

Any unproven stem cell treatment may be unsafe, posing serious risks to your health. The risks include infection, allergic reactions or the development of cancer, complications that can be fatal.

The only established stem cell treatment approved in Australia is haematopoietic stem cell (HPC) transplantation (using stem cells from umbilical cord blood or bone marrow), which is standard practice for the treatment of disorders of the blood and immune system such as leukaemia. The use of fresh bone marrow-derived HPC is standard practice and is exempt from oversight by us. Cord-blood derived HPC is usually stored frozen prior to use, so involves some processing, and is approved by us.

An unproven stem cell treatment may also pose serious, potentially fatal, risks to your health including infection, allergic reactions, rejection of the cells by your immune system and the development of cancer.

Unproven stem cell treatments may cause financial hardship, including treatment and ongoing follow-up costs, as well as the cost of emergency medical care in the event that something goes wrong. If you undergo treatment outside Australia, there are additional costs associated with travel.

Importantly, undergoing an unproven stem cell treatment may interfere with proven and potentially beneficial therapies recommended by your general practitioner or specialist. It can also disqualify you from participation in a registered clinical trial.

In Australia, the Therapeutic Goods Administration (TGA) is responsible for the regulation of products including human cells and tissues (termed 'biologicals'). This includes human stem cell treatments.

However, the TGA does not regulate medical practice. For this reason, some products that would otherwise be considered biologicals are excluded from TGA regulation (through the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011). Under this provision stem cell treatments may not be subject to regulation by TGA if they are human cells that are collected, processed and returned to the same patient, in a single course of treatment while under the clinical care and supervision of a registered medical practitioner.

It is important to note that if a stem cell treatment does not meet all of the criteria to be considered an excluded good, then the stem cell product would have to be evaluated and approved by the TGA before it can be provided to patients.

Cord blood can be stored in Australia. There are a number of approved facilities for storing cord blood stem cells (collected from a newborn's umbilical cord). There are currently no other TGA approved facilities for the storage of other stem cells in Australia.

We currently have no regulatory role in the storage of dental pulp, and are not aware of any product derived from dental pulp stem cells.

Within the deciduous teeth ('baby teeth') and adult teeth there is material known as dental pulp. This material contains a small number of stem cells. Some organisations offer to collect and store dental pulp as a future source of stem cells.

However, the use of these stem cells to produce a product that could be of therapeutic use is only at the development stage. It is possible that in coming years these stem cells will be used in a product for clinical trials, but full marketing approval by the TGA is still some time away.

Until a specific product is developed from dental pulp stem cells we have no oversight in its storage or use. If the dental stem cells were used in the future for a therapeutic purpose, the manufacturers (including storage facilities) of the stem cell product would need to meet the requirements of the TGA legislation of the time. At this time, it would require meeting standards for the quality and safety of the product and the demonstrated effectiveness of the final treatment.

Autologous cells are those that are removed from, and applied to, the same person, so the donor and recipient are the same.

Autologous cells are those that are removed from and applied to the same person. These cells may be treated, processed or purified after removal. As the cells come from the same person, there is a lower chance of reaction and rejection of the cells by the patient's immune system.

However, an unproven autologous stem cell treatment may be unsafe, posing serious risks to your health. The risks include infection and potentially ectopic tissue formation.

Unproven stem cell treatments may also involve significant financial costs, including treatment and follow-up costs, as well as the cost of emergency medical care in the event that something goes wrong. Undergoing an unproven stem cell treatment may interfere with proven and potentially beneficial therapies or treatment plans recommended by your general practitioner or specialist. It can also disqualify you from participation in a registered clinical trial.

The collection and use of cord blood stem cells for a specific patient is known as directed donation. On rare occasions, a hospital will collect and store a baby's cord blood for a family member who has a medical condition that can be treated with cord blood transplantation. This requires a treating doctor's approval.

The TGA ensures that where specific therapeutic claims are made about a product or therapy then these are supported and the product is safe. For natural therapies that do not have oversight by TGA there is no guarantee of safety or effective use.