A clinical trial is the testing of a new medicine or therapy on people. Every new medicine must undergo detailed clinical testing before it can be registered and made available to the community. By the time a study treatment gets to a stage where it is given to patients in clinical trials, it has been thoroughly researched in the laboratory.
Clinical trials are important for a number of reasons. For the area of stem cell application it is important to know if a treatment is not only safe but is also going to work. To comprehensively understand the workings of a new treatment for a human disease, it is necessary that it is tested on those the new treatment is intended to help.
Whilst the ASCC supports a diversity of research in both adult stem cell and embryonic stem cell fields, and have great faith in the long term therapeutic potential of stem cells, we are not yet at a stage where we are testing or offering any new stem cell-related treatments to patients. Our research projects are still very immature and it will be some years before we reach the stage of human clinical trials.
Without clinical trials it is impossible to fully understand if stem cells can act as an effective treatment for whichever condition it is being intended. Experimental treatments, even with evident successes, can not be deemed worthy by the medical community until tested properly and put under peer review. Peer review is when a therapy or treatment is independently assessed by at least one other expert in the field to validate its safety and efficacy measures.
The Australian Stem Cell Centre strongly encourages patients to consult with their specialist, who is best able to advise on suitability for clinical trials. The Australian Stem Cell Centre and the scientists and staff employed are not able to give any advice in relation to stem cell therapy or access to clinical trials or suitability. The following information is publicly available via the web. The Australian Stem Cell Centre has collated these references, but takes no responsibility for the accuracy of the information on the linked web sites or reference documents.
Further information on clinical trials
The
TGA website has detailed information on the regulation and process of clinical trials in Australia.
If you are after information regarding clinical trials within Australia, we suggest you search the Australian and New Zealand Clinical Trials registry,
www.anzctr.org.au. The advanced search function allows you to tailor your search results. This Clinical Trials Centre is affiliated with Sydney University and runs large multi-centre clinical trials, takes part in trials of national and international collaborative trial groups and contributes expertise to trials run by others.
Set up by the US National Institute of Health,
www.clinicaltrials.gov site provides regularly updated information about US federally and privately supported clinical research in human volunteers. In addition, it provides information about a trials purpose, who may participate, locations and telephone numbers for more details. The locations cover US and international based clinical trials including Australia.