A scanning electron microscope of a stem cell.
Credit: SPL
A new phrase of optimism has entered the global vocabulary over the past two decades: 'regenerative medicine'. Today, everyone seems to be interested in what life-enhancing products the field might yield.
Expectations are high, but the time frame for delivery remains speculative. This is because the term 'regenerative medicine' includes an array of projects, some with short and straightforward paths to market, and some with difficult and uncertain roads to success.
The field spans from the use of advanced technology to discover new drugs, to new biological agents focussed on tissue repair. Importantly, it also includes stem cell therapies for tissue replacement.
All of these technologies are evolving rapidly in laboratories around the world. Predictions that regenerative medicine will quickly become a US$20 billion (A$22.4 billion) industry are now common. The U.S. government is tracking 2,496 clinical trials of stem cell-based medicines, and several biotechnology companies are becoming recognised for their work in the field.
Currently Geron Corp in San Fransisco is working with the U.S. Food and Drug Administration to begin the first U.S. clinical trial using cells derived from embryonic stem cells. They will be using oligodendrocytes (a type of cell in the central nervous system) for spinal repair. Geron has also partnered with General Electric to commercialise cellular assay products derived from embryonic stem cells for use in drug discovery, development and toxicity screening.
And the biopharmaceutical company Athersys in Cleveland is using a bone marrow-derived product that can control inflammation. The company has partnered with Pfizer for treatment of inflammatory bowel disease. Celgene in New Jersey has used extracts of the human placenta to create cell products that treat Crohn's disease.
And these examples are just in the United States.
The emergence of cell therapeutics has much to do with the vision of scientists working to understand the biology of normal development and the opportunity to study the very early cleavage stage embryo as a result of research and clinical application of in vitro fertilisation (IVF). The California Institute for Regenerative Medicine (CIRM) was born on the optimism of some of these cell biologists and patient advocates of the therapy, and in spite of the ideological intransigence of former U.S. President George W Bush. Californian voters, in a citizen-initiated referendum, backed Proposition 71 in 2004 and created CIRM, which now provides US$3 billion (A$3.4 billion) in support of stem cell science and regenerative medicine.
The creation of CIRM galvanised other countries and states to support regenerative medicine. CIRM has a strong portfolio of collaborative partners - Britain, Germany, Spain, Japan, Canada, China, and the state of Victoria in Australia as well as the U.S. states of Maryland and New York. The world is now interlinked in our endeavours to deliver a major new medicine.
So what may we expect to happen over the next two decades? Most of the current clinical trials involve adult autologous (a medical term in which donor and recipient are the same person) cell therapies - using stem cells taken from the patient's own bone marrow or fat tissue. These are sometimes altered slightly, often expanded in number outside the body and then replaced in the patient.
Promise of regenerative medicine = delusion
Regenerative medicine, all sparkly and holy grailish, is all well and good. But means absolutely nothing to the vastest majority of patients who are so very poorly served by the structures and systems that are growing up to deliver just ordinary, humdrum medical interventions.
In the US and particularly the UK, patients' symptoms are routinely misdiagnosed and, on further complaint, patients are treated very shabbily. Every family in the UK has some sort of history of severe or potentially serious misdiagnosis/medical foul-up. Only yesterday, a good friend of mine, a doctor, told me how his little boy has been persistently misdiagnosed over the last 4 weeks with 'asthma'. It wasn't until my friend took the lad to ER with an audio recording of the coughing spasms that doctors FINALLY dxd whooping cough - a potentially fatal illness in a youngster with compromised immunity.This sort of lacksadaisical and/or cussed misdiagnosis is, as I said, routine. My friend was treated like a over-anxious twerp rather than an intelligent, naturally concerned parent.
However are these 'ground-breaking' scientists going to ensure that their dicoveried and innovations reach appropriate people when frontline doctors are so routinely careless??