Stem Cell Clinical Trial For Multiple Sclerosis Approved by FDA
Oct 04, 2013
The Tisch MS Research Center of New York announced on August 14 that the FDA has given its approval to begin a clinical trial to use stem cells in the treatment of multiple sclerosis.
Approximately 2.1 million people worldwide are affected by multiple sclerosis, a degenerative autoimmune disease that affects the nervous system and leads to myelin damage. According to Dr. Saud A. Sadiq, senior research scientist at Tisch, this is possibly the first effort in the U.S. that will investigate treatment of MS through direct injection of stem cells into the spinal fluid of patients. He says that the effort “represents an exciting advance in MS research and treatment.”
The Tisch MS Research Center is a unique organization with a novel approach to the treatment of multiple sclerosis. Dr. Sadiq has believed for over two decades that combining high standards of clinical care with research targeted at finding the cure to MS would improve the overall standard of treatment for MS patients. In short, at the Tisch center, your researcher is your doctor.
This is different from the standard model, where researchers spend the majority of their time conducting studies, trials, and lab work, while doctors apply the results of research in treating patients. By combining the two and allowing the doctor to conduct research tailored specifically to his patient, the center increases the pace at which discoveries can make it from lab to practice. This recent approval is evidence of the success of Dr. Sadiq’s philosophy.
The study in question will use stem cells harvested from the subject’s own bone marrow. Patients will undergo a single bone marrow collection. From there, the appropriate stem cells will be isolated and extracted, then tested before they are injected into the patient. Once this is complete, the cells will then be injected into the fluid surrounding the patient’s spinal cord, which early tests indicate will decrease inflammation in the brain and promote repair of CNS myelin, a protein-rich substance that is necessary for healthy nervous system functioning, and a substance which multiple sclerosis causes the body to attack and destroy.
In addition, early indicators are that the stem cells will also provide protection of the neurological system against the virus. Patients will receive three rounds of injections, one every three months, with safety and effectiveness being evaluated through regular follow-up appointments.
This application is the result of ten years of research into the use of stem cells to treat MS patients, conducted by a team of scientists headed by Dr. Sadiq and Dr. Violaine Harris, a research scientist at the Tisch Center.
Dr. Sadiq says, “This study exemplifies the Tisch MS Research Center’s dedication to translational research and provides a hope that established disability may be reversed in MS.”
For now, the trial is only a Phase I test, which means it’s still some time away from being widely and commercially available, but if successful, it could represent a major breakthrough in the treatment of MS, and could result in an increased quality of life in MS patients all over the world. Hear Dr. Sadiq talk about his hope for this clinical trial in the video.