Additional independent researchers from University at Buffalo will participate in the evaluation and follow-up of study patients. An independent Data Safety Monitoring Board (DSMB) will ensure the safety and effectiveness of the study on an ongoing basis.
In the first phase of the study, ten MS patients from the United States and Canada who exhibit venous insufficiency will undergo minimally invasive venous angioplasties to determine if the procedure can be performed safely. The procedures began June 29 and will continue today (June 30), performed by Siddiqui and Levy at Kaleida Health's Millard Fillmore Gates Hospital in Buffalo, New York.
In its second phase, the study will randomize 20 MS patients who will undergo either venous angioplasty or a "sham angioplasty" (i.e. a catheter will be inserted but there will be no inflation of the balloon). The treatment will be blinded in such a way that neither the patient undergoing the procedure nor the clinicians evaluating the patient will be aware which procedure was performed.
If results suggest an appropriate safety profile and preliminary effectiveness, researchers will approach the University at Buffalo IRB for an extension of the protocol to study a larger number of patients in order to convincingly prove or disprove a causal relationship between CCSVI and MS.
Multiple sclerosis is estimated to affect more than 400,000 people in the United States and more than two million people worldwide. It is typically a disease of young adults characterized by either a relapsing or progressive decline in neurologic function resulting in significant disability. It is an inflammatory neurological disease widely considered to be autoimmune in nature, though its exact origins remain elusive.
If angioplasty is proven effective at im
|Contact: Paul Dressel|
University at Buffalo