Studies Seeking Volunteers

Research studies that provide experimental treatments for spinal cord injuries need volunteers. The studies are being conducted with the approval and monitoring of the Food and Drug Administration. The experimental treatments are in various “stages” of development. To receive FDA approval to market a drug, a pharmaceutical company must conduct three stages of testing and trials establishing that the benefits of the new drug outweigh its risks.

Proneuron stage 2 trial

Proneuron, a pharmaceutical company, is conducting a stage 2 trial at five U.S. medical centers and one center in Israel. The trial tests whether one part of the body’s immune system can stimulate the spinal cord or brain to repair itself following injury. Macrophages are a type of white blood cell that our bodies produce. Macrophages are involved in the body’s response to injury and there is evidence that macrophages release chemicals that stimulate cell growth. Because of the unique way in which blood vessels in the brain and spinal cord are made, it is difficult for white blood cells to move from the blood to the brain or spinal cord tissue.

The Proneuron study involves 1) taking blood and skin from a patient; 2) isolating and treating macrophages for a day and a half with a patented process; and 3) injecting the spinal cord just below the injured area with the treated macrophages during a surgical procedure.

The study is limited to individuals whose injury is less than 14 days old. There are other requirements specific to the nature of the injury that are evaluated with an MRI. Two-thirds of the individuals qualifying for the study are given treated macrophages while the other one-third act as a control group and don’t receive the treatment (patients are not told which group they are assigned to). Information about the study is available at Clinical.Trial@proneuron.com or by calling 1-800-539-0767.

Other

The federal government's list of clinical trials for people with spinal cord injuries.