The Food and Drug Administration (FDA) announced today that it has approved the first clinical trial ever to test the use of human embryonic stem cells. The landmark experiment will test the safety and effectiveness of using embryonic stem cells to treat patients with recent spinal cord injuries.

The small phase I trial will involve giving a single injection of embryonic stem cells to eight to ten paraplegic patients within two weeks of suffering a spinal cord injury that leaves them with no sensation or movement in the legs. Prior to injection, the stem cells will be manipulated to become immature oligodendrocytes, cells that, when mature, insulate nerve cells and stimulate their growth. Previous studies conducted in animas have demonstrated the ability of these cells to regenerate nerve tissue.

The trial is to ensure the safety of the technique in humans, but the researchers will also be looking for improvements in function, such as the return of feeling or movement in the legs.

The study will be conducted by a biotechnology company at four to seven yet-to-be-determined sites around the country. After receiving an injection of stem cells at the site of their injury, patients will be given anti-rejection drugs for the first two months to prevent immune rejection of the cells. Researchers believe that anti-rejection treatment will not be necessary beyond this period.

The new study will be watched closely as it is the first to really test the potential of embryonic stem cells, which have been touted as a possible cure for everything from Parkinson’s disease to diabetes. Previous experiments have used adult human stem cells to treat such conditions as heart attack, but these cells are much more limited in their potential for repair. The promise of embryonic stem cells is that the cells can be coaxed into becoming literally any cell type in the body, from brain cells to insulin-producing cells in the pancreas.

Embryonic stem cells are controversial because they can only be obtained through the destruction of very early-stage human embryos. Former President Bush had restricted government funding of embryonic stem cell research to projects using embryonic stem cell lines that already exist. President Obama has pledged to amend that practice, but the FDA says that the decision to approve the present study was completely unrelated to the recent political change. The research plan for the study was drawn up before the election, uses stem cells already in existence, and did not rely on any federal funding.

For more information on coping with spinal cord injury or to share your thought on the announcement of this landmark study, join the conversation at the Healia Health Community for Spinal Cord Injuries and Diseases.

_{Photo: Ed Yourdon, Flickr, Creative Commons}