When will stem cell therapy be a reality?

BBC NEWS UK (April 1, 2009)

http://news.bbc.co.uk/2/hi/health/7961749.stm

Scientists have welcomed President Barack Obama's recent decision to allow research on human embryonic stem cells.

But in this week's Scrubbing Up health column Dr Elizabeth Hill, who advises investors on how to sell new technologies, says pharmaceutical and biotech companies need to act now so that patients can benefit in the future.

President Obama has lifted the restriction on US stem cell research, and has been hailed for ushering in an era of new possibilities.

Scientists can now collaborate openly and freely across the US and elsewhere without the restriction on what equipment, data or ideas can be shared.

But what does this mean to consumers?

Could this now mean the possibility of treatments for Parkinson's and Alzheimer's, now that researchers can thrive in their collaboration through federal funding and exchange ideas?

It's all very well doing research but how and when are new treatments going to be become a reality for patients?

Thinking ahead

The lifting of federal restrictions on stem cell research is most certainly refuelling interest in how stem cells can be used and two clear camps of research are emerging - the development of new drugs and stem cell therapy itself.

Pharmaceutical companies can now forge ahead with the development of new drugs using stem cells, an area that was until now not well supported by publicly funded research in academia.

Now that the amount of research is increasing, and pharmaceutical and biotech companies have more opportunities to work with academics, cell-based therapies could one day offer healthcare providers an effective low-cost treatment for

diabetes, some forms of blindness, heart attack, stroke, spinal cord damage and many other health problems.

As regards the development of stem cell therapy, the most promising treatment is autologous - where patients' own cells are harvested and re-introduced into their body.

Positive effects have been shown for the treatment of conditions including heart attacks and urinary incontinence.

We are already able to produce a wide range of tissues using adult stem cells, with spectacular progress in tissue building and repair.

We could also see some exciting new pharmaceutical products in the pipeline, which promise to do some of the same tricks without having to remove a single stem cell from the body.

These drugs may, for example, activate bone marrow cells and encourage them to migrate to parts of the body where repairs are needed. The big question affecting both drug development and stem cell therapies is whether pharmaceutical and biotechnology companies have the infrastructure in place to commercialise cell-based treatments.

Could cell-based therapies one day be administered in a pill or - more likely in the near-term - through a clinic, where the process of treatment from consultation to cell harvesting to administration would need to be in place?

Even if the walk-in clinic is the way stem cell therapy is eventually delivered, protocols to develop the treatment must be in place covering cell quality, safety, controls, dosage, cell preparation and administration.

It is not clear that either pharmaceutical companies or regulatory bodies have thought this far.

It appears once again that the science is one step ahead and that industry is playing catch-up.

'Get it together'

Pharmaceutical or biotech companies, focused on the development of treatments and used to the "develop - test - distribute" process, need to start making a complex array of decisions in parallel, covering strategies for sourcing and processing cells and for scaling-up so they are able to manufacture and distribute the therapy.

What makes cell based therapies unique is that they are in effect a personalised service. You absolutely cannot deliver the wrong sample to wrong patient.

The whole commercial model is quite different from the production of therapeutic treatments as delivered by a drug.

So despite the promise of stem cell research, will pharmaceutical companies just exploit stem cells as tool to improve drug research, leaving biotech companies and others to take to the lead in developing stem cell based therapies?

President Obama's action may speed up research and new potential cell-based therapies may be nearer, but until industry gears up to make it, process it, ship it, administer it, and regulate it - and until we determine who will pay for it - this new action, although welcome, may only be the start of a very long journey.

Of course, there is also the need to educate the consumer.

After all, if autologous stem cell treatments are to be pursued, the cells that treat me will belong to me.

That being the case, I will certainly want to make sure the healthcare system is suitably geared for it.

So now is the time for pharmaceutical and biotech companies to get it together so we can all benefit from new treatments.