At CIRM we routinely get emails and phone calls from patients desperately seeking clinical trials for themselves or for family members. With all the talk about future stem cell cures, it only makes sense that people would be looking to stem cells for help.
CIRM doesn’t maintain our own list of stem cell-based trials. Instead, we’ve always referred people to the national listing of all registered clinical trials maintained by the NIH: clinicaltrials.gov
Now we have a good resource for European patients, too. The European Medicines Agency yesterday revealed their new database of registered clinical trials in the EU: https://www.clinicaltrialsregister.eu/
Nature ran a story about the database on their blog:
Information on interventional trials run in all 27 EU member states, as well as Iceland, Liechtenstein and Norway, will now be searchable via the EU Clinical Trials Register website. The register effectively opens up the agency’s previously closed EudraCT database and brings Europe into line with the United States, which has long publicly listed all clinical trials online.
The old system attracted criticism from researchers concerned it would make it easier to bury bad results and hinder proper evidence-based medicine. (See, for example Europe’s clinical trial database criticized in Nature Medicine or New EU trials database is criticised for lack of openness from the BMJ, both 2004.)
People turning specifically to stem cells for hope can search either database by the term “stem cell”. A quick search of the U.S. database brought up 3459 results, most of them variations on bone marrow transplants for blood cancers and some immune diseases. A search of the new EU database pulled up 116 results, similarly focused on cancer and bone marrow transplantation. (It’s the blood forming stem cells in the bone marrow that reform the blood system after a transplant.)
Bone marrow transplants have been taking place for about 50 years now, so it’s no surprise trials to improve and expand on that technique dominate the databases. Over the past few years, some other types of adult stem cells have begun early phase clinical trials, including mesenchymal stem cells and neuronal stem cells, and now three trials based on embryonic stem cells are underway.
The NIH site has an especially good FAQ about clinical trials and how they are run, including a description of the different phases of the trials. Watching how people react to stem cell news it seems like an announcement of a new Phase I trial starting is often taken as proof that the cells are effective. (As in, there are more adult stem cells in phase I trials so obviously they are better than embryonic cells.) What that FAQ makes clear is that an initial Phase I trial is only intended to ensure that the potential therapy is safe in people. It’s not until Phase II that scientists expect to find some indication that the technique is effective and in Phase III that they might find proof that it works.
In time we should see more diversity in the types of stem cells that come up in a search of either clinical trial database. Hopefully these early trials with various types of adult or embryonic stem cells will produce some winners in addition to the inevitable failures.