First license to begin research involving therapeutic cloning

A special licensing committee of the UK Human Fertilization & Embryology Authority (HFEA) met on June 16 in London to decide whether to grant a license to scientists at The Center for Life at Newcastle University. If approved, this will be the first license to begin research involving cell nuclear replacement (therapeutic cloning), focusing on the treatment of diabetes in the UK and will be a first in Europe.

Therapeutic cloning, for the derivation of embryonic stem cells, has the potential to lead to cures for serious diseases such as Alheizmer's, Parkinson's, heart failure and cancer. The UK has a strict regulatory system for human embryonic stem cell research. If the license is approved, it will allow this important work to begin. The UK was one of the first countries in the world to pass legislation to explicitly ban reproductive cloning.

Dr. Miodrag Stojkovic of Newcastle University who leads the research team said that he was very happy that the law in the UK allows scientists to work in this very promising field and use their knowledge in stem cell biology and nuclear transfer technique to bring faster and more efficient stem cells from the bench to the patient's bed.

Newcastle University's Institute of Human Genetics and the Life Fertility Center is one of only two groups in the UK to derive human ES (embryonic stem cells) from spare IVF embryos.

ES cells can be used to make any cell type in the body and replace cells that have been lost as a result of disease or injury. Cells derived from ES cells may often be genetically different from the patient, and transplanted cells could be rejected by the patient's immune system.

The Newcastle stem cell group will use nuclear transfer to derive stem cells that are genetically identical to those of a patient. In this case the stem cells and cells derived from them would not be rejected after being transplanted into a patient.

Dr. Stojkovic explained that he plans to perform the cloning of dozens of embryos using the same technique employed by the scientists who created Dolly the sheep in 1997. The project will use cloned embryos to create insulin-producing cells that can be transplanted into people suffering from diabetes.

The procedure involves reprogramming cells from skin tissue of a patient who has lost important cells through disease or injury. The re-programmed cells will re-grow as the cells needed by that patient. For a child with diabetes this could then mean that he or she would not need to take insulin or any other medicines and would effectively be cured.

The process requires the nucleus from a skin cell to be removed and placed into an unfertilized egg. This egg is then stimulated to divide until a group of cells form. Stem cells are then isolated from this group and have the potential to grow into any cell type in the body. If directed to make insulin cells, a cure would be achieved.

Professor Alison Murdoch who leads the Newcastle Fertility Center at Life said that eggs would be donated for this research by patients undergoing treatment for fertility at the Center. Professor Murdoch said, "we are very grateful to all those patients who help with this research. Although the studies will not directly help them, they are playing a vital role in helping other patients."

Alastair Balls, chief executive for the Center for Life said, "This is undoubtedly one of the most important areas of research in human fertility and genetics capable of having a transformational effect on medical treatments. It is great news that Newcastle through the combination of the University, the NHS Trust and the Center is able to be one of the world leaders in this field.

To learn more about the regulation of stem cell research in the UK visit www.hfea.gov.uk.