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First Participants Enroll in Human Stem Cell Transplantation in the U.S.

The U.S. started enrollment for its first national clinical trials of therapies based on the use of human embryonic stem cells. Five sites are open for enrollment for stem cell therapy for patients with a severe spinal cord injury. They will enroll up to 10 participants nationwide. As of now, one site—Northwestern University Feinberg School of Medicine and The Rehabilitation Institute of Chicago— has enrolled its first subject, which is the second in this trial nationwide.

In the trial, patients are injected oligodendrocyte progenitor cells derived from embryonic stem cells. The cells are injected directly into the spinal cord lesion. The researchers expect that such a procedure will block or back up the spinal cord damage caused by the trauma.

The study will assess the safety of the treatment and the patients’ tolerance to oligidendrocyte progenitor cells. The secondary aim of the study is to evaluate if stem cell treatment improves sensation in the lower extremities or neuromuscular control. To be eligible for the procedure, the individuals must have injuries received within two weeks prior to the procedure.

The first participant of the trial was injected cells over a half year ago and has had no adverse effects up to date, though it is early to determine the improvements. The second patient received stem cells over the past weekend and will undergo a course of rehabilitation care. The rehabilitation care is customized to each patient.

Animal studies that were conducted prior to the clinical trial have shown that stem cell transplantation stimulated nerve growth and helped restore functions lost due to the trauma.