Clinical Trials Involving Stem Cells
At Smart Cells, we are often asked about clinical trials that are being undertaken using cord blood or cord tissue stem cells in the treatment of various diseases. Clinical trials are approved research studies involving patients, which compare a new or different type of treatment with the best treatment currently available (if there is one). No matter how promising a new treatment using stem cells may appear during laboratory pre-clinical tests, it should go through clinical trials before its benefits and risks can be determined.
Trials are usually conducted by well recognised and respected establishments, and aim to find out if treatments are safe and if they result in benefit for patients. Any new treatments, including those using stem cells, usually have to go through a series of clinical trial phases to test whether they are safe and effective.
The Phases of Clinical Trials
- Phase I trials look at the safety and any side effects of a new treatment such a novel stem cell therapy. Phase I trials usually involve only a small number of people.
- Phase II trials build on the findings of phase I trial results. Larger numbers of patients are involved and safety is again a consideration but more in depth analysis of cell dosing and administration is undertaken in stem cell trials for example. In these trials, clinical outcome is analysed in more detail.
- Phase III trials go to the next level and this involves randomising patients into groups who either receive the new treatment or not. Those who do not receive the new therapy may either be given the best available current treatment or sometimes a placebo. This type of trial aims to accurately assess the effectiveness of the new treatment and more about the mechanisms involved in the way it works.
- Phase IV trials are done after the treatment has already been approved by regulatory authorities. These trials are undertaken to gather information about the treatment in various populations and any side effects associated in long term follow up.
If you would like to learn more about clinical trials using stem cells or search some of the worldwide clinical trial databases to look for a trial, please follow these links to Parent’s Guide to Cord Blood and Bio Informant.