Safety and effectiveness of stem cell therapy

STEM cell therapy refers to the use of stem cells to treat various diseases. Stem cells are capable of replicating (proliferate) and have the capacity to differentiate into specialised cell types.

The most widely used stem cell treatment is the transplantation of hematopoietic stem cells derived from bone marrow or umbilical cord blood.

We can see a range of products in Malaysia now with the “stem cell” branding, promising alternative and therapeutic potential for a range of conditions including osteoarthritis, neuro-degenerative disease, ocular disorder, heart disease, spinal cord injury, and Parkinson’s disease.

As such, the public must be made aware, that research on stem cell therapy is still ongoing and that it is being investigated at the clinical trial phase.

Evidence-based reports from all stages of clinical trials which the proposed treatment must go through are necessary to ensure it will be safe and effective.

Thus, products related to stem cell therapy need to be regulated by the national health authorities.

A recent study published in the British medical journal The Lancet showed that patients who received stem cell treatment had a lower rate of heart failure problems.

Though that could appear to be good news to millions of patients with the disease, more translational research (the process by which basic scientific discoveries are transformed through clinical application into new medical treatments and products to enhance the diagnosis, treatments, and prevention of diseases) still need to be done.

On the other hand, a science blog reported that a nine-year-old boy suffering from a crippling illness was diagnosed with a brain tumour a few years after receiving stem cell therapy through injections of foetal stem cells into various regions of his brain. This is the danger of seeking unproven treatments.

The recent Malaysian Association for Cell Therapy (MACT) symposium in Kuala Lumpur, which brought academics, clinicians, industry players and regulatory bodies together for a dialogue session on the cellular therapy development in Malaysia, was a timely effort by the MACT given that the newly-introduced guidelines for registration of cell and gene therapy products (CGTPs) will be enforced in five years’ time.

In time to come, the health authorities including the Medical Research and Ethics Committee (MREC), which handles applications for clinical trials, and the Medical Service Development Division of the Health Ministry, Clinical Research Centre (CRC), Clinical Research Malaysia (CRM), National Pharmaceutical Control Bureau (NPCB), National Stem Cell Research and Ethics Sub-com­mit­tee, Institute for Medical Research (IMR), Malaysian Stem Cell Registry, the various ethics committees at universities and medical centres, the BioMedical Division of Biotech Corporation, investors, fund providers and other stakeholders, could get together in public dialogue sessions to provide more insight on the progress of cell therapy and the funding mechanism involved in clinical trials, and to keep the public informed about the current developments in stem cell therapy. A continuous engagement between researchers and the public is necessary to build trust and confidence on issues concerning healthcare and research funding.

S. MATHANA AMARIS FIONA

Puchong