I’m currently attending Till & McCulloch meeting in Montreal. It has been a great conference with fantastic opportunity to network. I’m planning to cover some exciting, in my opinion, topics in few upcoming posts. Today, I’d like to summarize and share some of the talks on clinical translation of stem cell therapies.
There were a lot of great “translational talks”, capturing the problem from different perspectives. Tania Bubela from U of Alberta has indicated that unrealistic public expectations is a major non-scientific challenge in clinical translation. Her team have identified a large discrepancy between public expectations (measured by mass media coverage) and real picture (publications, clinical trials). The problem is that if these expectations are not addressed, support for stem cell research and translation could be seriously affected.
Yet another challenge, noted by many speakers, is regulatory framework. Tania Bubela has proposed that in order to solve discrepancy between public expectations and delivery of real stem cell therapy, we need to have rational conversation with regulators. By answering my question about who and how should do that, she pointed to professional network organizations, such as Canadian Stem Cell Network, which could play an important role.
Despite the non-scientific challenges (over-hyped public expectations and regulation), we are still frequently lacking a good science and evidence in pre-clinical stages. Brian Kwon has delivered an excellent talk on readiness for clinical trials in spinal cord injury. He asked: “Are we ready for real thing?”. His systematic analysis indicated that, in fact, we are not ready. Most of therapeutic goals in research are reportedly being achieved, but models are not relevant and reproducibility is lacking. For example, preclinical work on Geron’s trial was never independently reproduced, never done on large animals, yielded a little therapeutic benefit and approval was based entirely on single paper. Taking in account the huge cost of the trials and a length of 10-15 years, we shouldn’t think of it as a casual thing that we can easily try and see what happen. Each criteria for pre-clinical testing, proposed by professionals, should be rigorously assessed and checked. He said: “Is the science good enough? – stop kidding yourself!”
Tim’s Caulfield team has done very interesting work on influence of “external factors” on stem cell researchers. They surveyed members of international stem cell research communities and found that the pressure for clinical translation was moderate in 64%, intense – in 24% and non-existent in 12%. Emphasis on economic benefit of stem cell research was indicated as “little” by 44% of researchers, big – 40% and none – 14%.
One of the general themes of the conference was the agreement on pivotal role of collaboration in clinical translation. Collaboration on all possible levels! Bartha Knoppers called for solidarity in stem cell research and creation of “Data Commons”. Traceability and identifiability are becoming extremely important criteria of a progress in stem cell research. During the commercialization session, Greg Bonfiglio said: “Think about your competitors as potential collaborators”. He thinks that collaboration is a future key element in successful commercialization of regenerative medicine. Bongfilio also emphasizes the role of academic-based translational centers, which could serve as “bioincubators” for the training and early stages of cell product development. One of the examples of such center is Canadian CCRM.