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}

Although stem cells may one day prove to be effective treatments against many of the most devastating medical conditions and their use in medicine may become commonplace, a new study reports that several “rogue” stem cell clinics are already making such premature claims about stem cell treatments on their Web sites. These clinics are portraying the therapies they offer as safe, effective, and ready for routine use.

In a report published in the December issue of Cell: Stem Cell, researchers caution that patients should be wary of stem cell clinics that make confident claims about their services without firm medical evidence to back it up, because the existing published research does not support that "overoptimistic" picture.

At least 19 different Web sites offer stem cell therapies at clinics in countries such as China, Mexico, and Russia where there are fewer restrictions on the use of stem cells than in the United States. The Web sites tout treatments for conditions including multiple sclerosis, Parkinson's and Alzheimer's diseases, spinal cord injury, blindness, stroke, and heart attack.

In recent years, desperate patients with such conditions have visited overseas clinics believing them to be their last hope. While a review of published medical studies finds some encouraging evidence for the use of stem cells to treat such conditions, there is not yet any clear evidence of benefit from such treatment, and many studies cite the risk of serious side effects. In addition, the study notes the average cost of a course of such treatment was $21,500, excluding travel and accommodation for patients and care givers.

In the same issue of the journal, a report from the International Society for Stem Cell Research (ISSCR) describes new research guidelines that condemn the marketing of unproven therapies. The society has posted a patient handbook on its Web site to help people who are considering stem cell therapy.

The guidelines say that in limited cases, doctors may be justified in trying an experimental treatment outside of a formal study for small numbers of seriously ill patients. The guidelines recommend standards for that situation, such as approval from a group of experts with no vested interest in the treatment and a commitment by those offering it to proceed to a formal study. Read the complete guidelines in the patient handbook on the ISSCR website. 

If you or someone you know is facing a serious condition that might benefit from stem cells, keep in mind that there are controlled studies being conducted in the Untied States to examine the use of stem cells to treat several diseases. While these studies are usually small, if you meet the criteria for such a study you may be able to receive stem cell treatment for free. Such studies will ultimately help researchers determine if the grand potential of stem cells is real. To find a clinical trial involving stem cells, search Healia Clinical Trials Search for stem cells, or search Healia Clinical Trials Search for a particular disease (e.g. Parkinson’s disease).

_{Photo: Daino_16, stock.xchng, sxu license}

As football season kicked off, our office chatter has centered around fantasy football leagues, teams, and individual players. This week we’ve been following Buffalo Bill tight end Kevin Everett, who suffered a major spinal cord injury during Sunday’s game.

Minutes after his injury, Everett received an experimental therapy, an intravenous ice-cold saline solution, which put him in a hypothermic state. The idea behind the treatment is to lower the body temperature to restrict damage to the spinal cord.

“Right now, it's not mainstream medicine” said Dr. Barth Green, co-founder of the Miami Project to Cure Paralysis at the University of Miami, who has helped develop the treatment.

Amazingly, as of Thursday, Everett can wiggle his toes, bend his hip, move his ankles, elevate and kick his leg, as well as extend his elbows and slightly flex his biceps. While all are significant signs of improvement, Everett has yet to show any movement in his hands.

The experimental therapy is still under scrutiny and doctors don’t have enough information to give a long-term prognosis. They are being cautious because he is still susceptible to life-threatening events like blood clots, infection and breathing failure.

For more information on spinal cord injury and repair, search www.healia.com.

spinal cord injuries spinal cord ice-cold saline solution