Stem Cells Trial Official Approved

Stem Cells

It’s official. For the first time, the doctors injected to a patient with a spinal cord injury, human embryonic stem cells. A biomedical firm said Monday that the experiment was finally federally approved.

The FDA (Food and Drug Administration) officials agreed to the start of a private funded safety trial in July. The doctors waited for a long time to test the cells and now they had the opportunity. The cells are grown from a single embryo to resemble forerunners to spinal cells. A patient at the Shepherd Center, an Atlanta hospital specializing in brain, spine and related ailments, received the cells. The first cells were grown in 1998. Since then, the medical researchers looked to the cells to study organ development. Now, the researchers they grow rejection-free replacement organs.

“Many predicted that it would be a number of decades before a cell therapy would be approved for human clinical trials,” said in a statement by Thomas Okarma of the experiment’s sponsor, Geron Corp. of Menlo Park, California. Okarma called the start of this trial at the Shepherd Center and six other facilities “a milestone” for a promising field of human embryonic stem cell research.

In the trial, the patients receive injections of about 2 million cells grown specifically to resemble precursors to spinal cord cells. The patients receive them within 7 to 14 days of injuries to their middle back, or thoracic vertebrae. The cells should grow into spinal tissues, helping to repair the injury occurred at the patient. Also, the immune systems will be injected with drugs for months to help prevent the rejection.

“I would say this is akin to organ transplantation,” said Allison Ebert from the University of Wisconsin. Ebert is a stem cell researcher who was not part of the study. “This is just a study for safety to see how these cells respond to the human spinal cord. But it is a logical step, one of many in the pipeline.”

Jane Sanders, a spokeswoman from the Shepherd Center said that they can’t provide additional information about the patient and also they can not allow any interviews with the physicians at this time because of medical privacy concerns.

Okarma said that the spinal precursor cells used in this study show that they don’t develop the ability to antagonize the immune system. The FDA held up the approval of these trials for months. They requested extra animal safety studies. “Even if this trial turns out to be negative, these data will be useful …making it an important first step,” said Ebert.

The research using human embryonic stem cells has always been controversial, because the cells are grown from ones taken from the destruction of 5- to 6-day-old human embryos. Citing moral qualms in a 2001 announcement, the president George Bush limited the federal funding of research using human embryonic stem cells to 21 already-created stem cell colonies, or lines. President Obama reversed Bush’s policy and it led to the FDA approval for these clinical trials to begin this year.