The FDA gave New York’s Tisch MS Research Center a green-light to move forward with a 1st-of-its-kind Phase I investigational new drug trial that will aim to treat multiple sclerosis with a direct spine injection of the patient’s own stem cells.
MS is an autoimmune disease that attacks the central nervous system and afflicts more than 2 million people worldwide. Tisch will treat 20 patients with their own stem cells, extracted from bone marrow and injected into the fluid that surrounds the spinal cord.
"To my knowledge, this is the 1st FDA-approved stem cell trial in the United States to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment," Dr. Saud Sadiq, director of Tisch and lead investigator, said in prepared remarks.
Based on promising non-human research, the Tisch research team hopes the treatment will reduce brain inflammation and repair the myelin sheath, cells that protect the nerves.
After the bone marrow cells are extracted, researchers will isolate a specific type of stem cell, called the neural progenitor. Patients will be given 3 injections of these cells, spaced at 3-month intervals.