Stem cells: Potential, Promises, Practices and Pitfalls
Stem cell is the current buzzword in medicine. Many are inspired and excited by this powerful and pluripotent cell which is able to self-renew and differentiate into different types of tissues. Imagine the capability of the stem cells to repair the damaged heart muscle due to a myocardial infarction, or replacing damaged neurons in stroke patients or even the degenerative memory cells in Alzheimer’s disease. The potential is huge. I don’t blame doctors and researchers who are thrilled about this and are eager to help their patients. The promises are plenty even since stem cells were discovered many years ago. But many of these promises are yet to be delivered. It is an important field but there is still some way to go. Yes, there are many ongoing trials worldwide and some have shown promising results. We need to wait patiently for these trials to conclude. As medical practitioners and researchers, we have to follow regulations. Stem cells are considered as biologics and most if not all regulatory authorities treat any clinical trial involving stem cell as similar to the clinical trial for a new investigational drug (IND). Because of the potential and promises, regulating the practices of stem cells for unproven indications is a big challenge. There are pitfalls and there are misrepresentations. Even the cosmetic industries are capitalizing on the phrase ‘stem cells’ to sell their products. There are doctors who offer stem cell or cell therapies for unproven indications, and regulating this are even more challenging. Yes, there is a demand out there especially from patients who have no more options for treatment and for these patients there is nothing to lose, except for their savings. Those who sit in regulatory and ethics committees are facing the challenge and pressure of clinicians and researchers who want their proposals and products to be approved even when many have not conformed to the standard requirements. Foreign stem cell companies are coming into the country under the guise of making Malaysia the hub for this latest technology, promising foreign investments that excite the business people, and they strategically meet with the appropriate ministers or the relevant agencies related to biotechnology or clinical trials. The Ministry of Health is responsible for the regulation of stem cell and cell therapy through the relevant agencies and divisions. There are guidelines but there is no specific Act yet to govern the practice. There are still gaps and loopholes but for us doctors and researchers, it remains our shared responsibility to ensure that the public and patients are protected from the false promises, unproven therapies and also making sure the products are safe before being given to patients.