The surgery took place in two stages March 6-7 and the patient was discharged from Yale-New Haven Hospital March 10. The young man is the second of five patients who are scheduled to participate in the groundbreaking clinical trial.
"The patient is doing fine," said Timothy Vollmer, M.D., associate professor of neurology at Yale School of Medicine. "He has a high level of disability because of the location of the lesions in the brain, but he is otherwise healthy."
There are an estimated 1.4 million persons worldwide with multiple sclerosis. The young man in the trial suffers from a relapsing form of multiple sclerosis, which Vollmer said is the most common form of multiple sclerosis. It affects three times as many women as men.
Vollmer said he and his team hope to perform the procedure on a third patient next month.
The purpose of the Phase One trial is to determine whether cells found in the body’s peripheral nerves, in this case, the ankle, can safely repair the damaged cells in the brain and spinal cord that result in neurologic disability in patients with multiple sclerosis and other disorders of myelin.
In multiple sclerosis, the immune system attacks the brain’s nerve fibers and strips away the protective myelin sheath around nerve fibers in the spinal cord and brain. The resulting lesions make it difficult for the nerves to transmit messages.
In the first procedure on March 6, the surgical team harvested Schwann cells from the patient’s ankle. Animal studies show that Schwann cells can replace the cells that generate the myelin. The second day, the cells were injected into the left posterior aspect of the patient’s brain, which has lesions.
Vollmer said he and his team want to determine whether the Schwann cells survive in the brain and if they are able to restore myelin on the nerve fibers in the brain. The patient’s progress is then monitored for six months using neuroimaging and other tests. After six months a small biopsy is taken to determine whether the cells survived and whether they made any myelin.
The six month results on the first patient will not be made public until they are published in a peer-reviewed medical journal.
Vollmer’s team includes Jeffrey Kocsis, Dennis Spencer, M.D., Stephen Waxman, M.D., Adam Anderson, John Gore and others. The research is fully funded by The Myelin Project in Washington, D.C.