Prof. Richard Boyd attended the 2014 Stem Cell Summit in New York. The one-day event featured over 20 speakers and covered nine hot topics on stem cells at the moment.
The advances in the clinical translation of stem cells has been dramatic in past 12-18 month and this Summit showcased many of them.
Professor Boyd found the event extremely encouraging. Most exciting were the recent stem cell trials recently undertaken and discussed on the day which have seen no reported side effects and positive signs of efficacy.
He answers a few questions on the event highlights:
You've attended many conferences on stem cells in the past, did you notice a shift in attitudes to stem cell therapies at this event?
It was very apparent to me many of the prejudices, safety concerns and perceived lack of progress in the field were now being dispelled.
The Summit was really well structured to capture overviews by key opinion leaders within the stem cell commercial world.
The major steps forward were striking with clear evidence of clinical efficacy in several disease settings using mesenchymal stem/stromal cells - particularly spinal disc repair (MSC often coupled to nano-support structures) and osteoarthritis.
For the latter there is now clear evidence for articular cartilage repair.
Were there any significant advancements in the treatment of Osteoarthritis discussed?
There were many presentations on the successful treatment of Osteoarthritis, particularly from a pain management perspective.
But the most impressive data were from the Cellular Biomedicine Group in China who have undertaken a suite of clinical trials using a variety of different cells for multiple disease types.
Most relevant for the treatment of OsteoArthritis and consistent with the recent Korean studies, they showed very clear evidence of cartilage regeneration with high dose cells; they also used SVF plus MSC which was also successful. Their commercial model however, is the use of their proprietary cell lines.
Were there any controversial presentations?
Ironically the most controversial talk was from Andrew Littleman - the lawyer who defended Cetrulo against the FDA.
He presented the complexities of the law and peculiarities in the wording as approvals or not. For example, you could say "you are applying stem cells as a wound dressing" without issue but you could not say "treating a wound" as the latter implies functional efficacy. Not so much controversial.
How do you you think US (over) regulation and the FDA pressure on US companies, will impact stem cell treatment here in Australia?
There is real turmoil and frustration in the USA. While the FDA has as its important charter the need to ensure best clinical practice, the ban on non-clinical trial treatments is contrary to the needs of many patients willing to "pay for procedure" as part of developing stem cells as legitimate medicines.
The TGA Biological Exemption in Australia was seen by many companies and clinicians I spoke to as being a remarkable opportunity to couple company sponsored clinical trials with that of patients "paying for procedure". This scenario becomes even more attractive for stem cell therapy development in Australia given the Tax Rebate (now 43.5%) for research expenditure.
What were the highlights from your perspective?
Clearly the highlights were the rapidly evolving story of the successful clinical effects (in Stem Cell Therapy) and also the number of multiple companies in the same clinical areas.