How unethical operators are hurting stem cell therapy development

Within the medical and broader community, there is some confusion over what constitutes stem cell therapy.

In brief, stem cells were first recognised within bone marrow. They displayed plasticity and multipotency, being able to differentiate along different cell paths.

Cells with similar characteristics have also been identified within peripheral tissues and are more accurately called mesenchymalstromal cells (MSC).  A recent systematic review and analysis of published trials concluded that MSC therapy is safe.

One of the most common techniques for harvesting adult MSCs is through liposuction.

After removal of lipid cells, a mixed population of cells known as stromal vascular fraction (SVF), remains. 

The critical difference is, the majority of clinics offering ‘stem cell therapies are using SVF of which only 1-10% of the cells are indeed MSC.

Unfortunately, in an effort to capitalise on publicity about stem cell therapies potential health benefits, some individuals and groups are offering treatments with:

1. Little scientific evidence

2.  Even fewer stem cells

This behaviour undermines the potential value of legitimate stem cell therapies and the real promise that such therapies display.

Melbourne Stem Cell Centre is unique in that it isolates and expands the mesenchymal stem cell population within SVF to create a `pure’ high dose MSCs preparation/therapy.

I believe that before any stem cell treatments can be undertaken, there must be strong evidence of preclinical safety and functional evidence in relevant animal models of the disease in question.

Due to exemptions for autologous biological therapies under current TGA legislation, Australia is an enviable position to develop the clinical application of this emerging treatment.

The question still remain, how should this technology be regulated?

Professor Richard Boyd (Link to Prof. Boyd) director of the former Monash Immunology and Stem Cell Laboratories at Monash University, has led the drive to develop an industry code of ethics for stem cell therapy, with the support of companies and research clinics involved in this area.

Both Prof. Boyd and the team at the Melbourne Stem Cell Centre believe a strong emphasis on ethics and research can help Australia become an international leader in the clinical application of stem cells and the development of evidence based cell therapies.

Working alongside organisations such as the NHMRC and Stem Cells Australia, we need to protect the development and integrity of a therapy that could prove revolutionary.

By Julien Freitag