Clinical Development

Any new therapy in Regenerative Medicine will have to be tested in a clinical trial to show that it is safe, has few if any side-effects and is effective before being approved for use. Often the new therapy is compared to the best available therapy as well.

Clinical trials generally follow a 4 step strategy;

  • Phase 1 trials look at whether a trial treatment is safe or has any harmful effects - the research team will also find out the best dose to use.
  • Phase 2 trials look at how well a treatment works - only treatments that have got through these 2 phases go into phase 3 testing.
  • Phase 3 trials test a new treatment against the existing standard treatment - if it gives better results, it may become the new standard treatment.
  • Phase 4 trials are carried out after a drug has been licensed - they collect information about side effects, safety and the long term risks and benefits of a drug.

For more general information please visit Cancer Research UK

If you are a researcher and planning a trial, visit The Department of Health which has a very helpful section to help you plan your clinical trial and get approval. On this site you will also find practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations implement the EU Clinical Trials Directive (PDF).

Clinical trials require human volunteers so if you are interested in volunteering check with your local hospital or the websites of the major charities in the regenerative medicine field such as the MS Society to see what trials are coming up.

Leading Developments

Scotland is a global leader in regenerative medicine research with the following programs:

  • Universities of Dundee and Aberdeen – Diabetes
  • University of Edinburgh - Multiple Sclerosis, Motor Neurone Disease, musculo-skeletal, corneal and blood
  • University of Glasgow - Cardiovascular disease and stroke

There are a number of clinical trials planned or in progress:

  • Corneal blindness in Edinburgh
  • Stroke in Glasgow
  • Liver cirrhosis in Edinburgh