Stem cell therapy: Facts worth noting

Dr Janice Simmonds-Fisher, Contributor

There is always controversy in the word stem cells. After all, the research started with the use of embryos, and there are many who still believe that stem cells only come from embryos.

Stem cells are actually in all tissue and are the basis of our repair and regeneration. There are many forms of stem cells, including the controversial embryonic, fetal, cord blood and then there are adult stem cells. We have to make a distinction with adult stem cells and clarify a number of points.

I treat patients using adult stem cells. There is absolutely no ethical dilemma with adult stem cells. The risk of tumour formation is not seen in adult stem cells

Adult stem-cell treatments can be from various sources. Stem cells harvested from the blood have never been classified as drugs and have been in use for over 30 years. With this application, we are using old therapies in new diseases. We are already utilising these therapies in Jamaica for other disorders.

In Cuba, they have been using what is called mobilised peripheral blood stem cells for the past ten years to improve poor circulation of the legs, in arthritis, and to heal old ulcers. We also employ mobilised peripheral blood stem cell therapy for certain conditions and, again, this has no FDA restrictions in the USA.

Again, there are absolutely no ethical or safety dilemmas once these are performed within guidelines.

With stem cells from fat, there are some differences. If the cells are not altered in any way, they do not fall under direct Food and Drug Administration (FDA) regulations and are under direct guidelines of Institutional Review Boards (IRB) of physicians within a state.

There have been hundreds of studies using these therapies in different areas. The aim is not drug development, but to see the effectiveness, as they have already been proven safe for many years now.

There are IRB-approved protocols in arthritis and other orthopaedic disorders, chronic lung disease, erectile dysfunction, diabetes and poor circulation to the legs.

Stem cells from fat that are altered or engineered are the basis of new drug developments and are in different stages of trials. They are investigational, and still years away from completeness. This is quite separate from what we do.

Pharmaceutical companies are developing stem cells that have been showing promise in many areas. This is strictly regulated by the FDA, especially drugs containing cultured, embryonic or cord blood cells. They have one approval so far.

I am aware that there are centres offering cultured products that the FDA classifies as drugs; we do not, and have no desire to do so.

given approval

As the corollary to the Institutional Review Boards in the United States, we sought the guidance of senior colleagues, and presented our protocols for using some of these already approved protocols in the specified conditions. We have been given approval, and enjoy the blessings of the Medical Council of Jamaica.

We know that fracture healing can be enhanced from stem cells from the bone marrow, blood or fat. We know that ulcers can heal from stem cells in the bone marrow, blood or fat. This we have already been doing in Jamaica, some forms for many years and others just beginning.

There are warnings and inserts in every drug that are there for our guidance, not to hinder us, but to remind us of the appropriateness of usage.

Knowledge is important, and training is pivotal. Let us not bury our heads in the sand. We have been using these therapies in other areas, and we are expanding the areas of possible applications and studying the effectiveness for new conditions.

It is inevitable that we will be using more of these treatments. Certainly, all orthopaedic surgeons and cardiologists have already had the thought. It is imperative that we continue to work together and improve these techniques to help our patients.

We are all on the same side, we just occupy different roles.

Dr Janice Simmonds-Fisher can be contacted at stemcelljamaica@gmail.com, Bio-regeneration Medical 632-5228. Email: yourhealth@gleanerjm.com