FAIRFAX, Va. — Recognizing that venous interventions may potentially play an important role in treating some patients who suffer from multiple sclerosis — an incurable, disabling disease — the Society of Interventional Radiology has issued a position statement indicating its support for high-quality clinical research to determine the safety and effectiveness of interventional M.S. treatments. SIR’s position statement is endorsed by the Canadian Interventional Radiology Association and will be published in the September Journal of Vascular and Interventional Radiology.
“The Society of Interventional Radiology would like to be actively involved in developing evidence-based therapies for the potential treatment of patients with multiple sclerosis,” said SIR President James F. Benenati, M.D., FSIR. “Completing high-quality studies — for example, on chronic cerebrospinal venous insufficiency (CCSVI, a reported abnormality in blood drainage from the brain and spinal cord) and interventional M.S. treatments — should be a research priority for investigators, funding agencies and M.S. community advocates,” added Benenati, who represents nearly 4,700 doctors, scientists and allied health professionals dedicated to improving health care through minimally invasive treatments.
About 500,000 people in the United States have M.S., and SIR understands the public’s desire to advance treatment for M.S., generally thought of as an autoimmune disease¬ in which a person’s body attacks its own cells. Currently, medicines may slow the disease and help control symptoms. The role of CCSVI in M.S. and its endovascular treatment (through a catheter placed in a vein) by an interventional radiologist via balloon angioplasty and/or stents to open up veins “could be transformative for patients and is being actively investigated,” said Benenati. “The idea that there may be a venous component to the etiology (or cause) of some symptoms in patients with M.S. is a radical departure from current medical thinking,” he noted.
“SIR recognizes the challenge and the potential opportunity presented by promising early studies of an interventional approach to the treatment of M.S.,” said Benenati. SIR is moving rapidly to “catalyze” the development of needed studies by bringing together expert researchers in image-guided venous interventions, neurology, central nervous system imaging, M.S. outcomes assessment and clinical trial methodology, he added. While the use of balloon angioplasty and stents cannot be endorsed yet as a routine clinical treatment for M.S., SIR is committed to assuming a national leadership role in launching needed efforts, said Benenati.
SIR’s position statement agrees with M.S. advocates, physicians and other caregivers that the use of any treatment (anti-inflammatory, immunomodulatory, interventional or other) in M.S. patients should be based on an individualized assessment of the patient’s disease status, his or her tolerance of previous therapies, the particular treatment’s scientific plausibility, and the strength and methodological quality of its supporting clinical evidence. “When conclusive evidence is lacking, SIR believes that these often difficult decisions are best made by individual patients, their families and their physicians,” notes “Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis: A Position Statement by the Society of Interventional Radiology, Endorsed by the Canadian Interventional Radiology Association.”
If interventional therapy proves to be effective, M.S. patients should be treated by doctors who have specialized expertise and training in delivering image-guided venous treatments, said Benenati. Interventional radiologists pioneered balloon angioplasty and stent placements and use those treatments on a daily basis in thousands of patients with diverse venous conditions. “Interventional radiologists are steeped in a tradition of innovation and invention — of pioneering modern medicine with the devices, drugs and methods to treat patients minimally invasively,” said Benenati.
For more information about the Society of Interventional Radiology and to find those interventional radiologists who provide endovascular treatment for CCSVI, visit SIR’s Web site at www.SIRweb.org and its Doctor Finder at http://doctor-finder.SIRweb.org/.
About the Society of Interventional Radiology
Interventional radiologists are physicians who specialize in minimally invasive, targeted treatments. They offer the most in-depth knowledge of the least invasive treatments available coupled with diagnostic and clinical experience across all specialties. They use X-ray, MRI and other imaging to advance a catheter in the body, such as in an artery, to treat at the source of the disease internally. As the inventors of angioplasty and the catheter-delivered stent, which were first used in the legs to treat peripheral arterial disease, interventional radiologists pioneered minimally invasive modern medicine. Today, interventional oncology is a growing specialty area of interventional radiology. Interventional radiologists can deliver treatments for cancer directly to the tumor without significant side effects or damage to nearby normal tissue.
Many conditions that once required surgery can be treated less invasively by interventional radiologists. Interventional radiology treatments offer less risk, less pain and less recovery time compared to open surgery. Visit www.SIRweb.org.
Stem cells are “non-specialized” cells that have the potential to form into other types of specific cells, such as blood, muscles or nerves. They are unlike “differentiated” cells which have already become whatever organ or structure they are in the body. Stem cells are present throughout our body, but more abundant in a fetus.
Medical researchers and scientists believe that stem cell therapy will, in the near future, advance medicine dramatically and change the course of disease treatment. This is because stem cells have the ability to grow into any kind of cell and, if transplanted into the body, will relocate to the damaged tissue, replacing it. For example, neural cells in the spinal cord, brain, optic nerves, or other parts of the central nervous system that have been injured can be replaced by injected stem cells. Various stem cell therapies are already practiced, a popular one being bone marrow transplants that are used to treat leukemia. In theory and in fact, lifeless cells anywhere in the body, no matter what the cause of the disease or injury, can be replaced with vigorous new cells because of the remarkable plasticity of stem cells. Biomed companies predict that with all of the research activity in stem cell therapy currently being directed toward the technology, a wider range of disease types including cancer, diabetes, spinal cord injury, and even multiple sclerosis will be effectively treated in the future. Recently announced trials are now underway to study both safety and efficacy of autologous stem cell transplantation in MS patients because of promising early results from previous trials.
History
Research into stem cells grew out of the findings of two Canadian researchers, Dr’s James Till and Ernest McCulloch at the University of Toronto in 1961. They were the first to publish their experimental results into the existence of stem cells in a scientific journal. Till and McCulloch documented the way in which embryonic stem cells differentiate themselves to become mature cell tissue. Their discovery opened the door for others to develop the first medical use of stem cells in bone marrow transplantation for leukemia. Over the next 50 years their early work has led to our current state of medical practice where modern science believes that new treatments for chronic diseases including MS, diabetes, spinal cord injuries and many more disease conditions are just around the corner.
There are a number of sources of stem cells, namely, adult cells generally extracted from bone marrow, cord cells, extracted during pregnancy and cryogenically stored, and embryonic cells, extracted from an embryo before the cells start to differentiate. As to source and method of acquiring stem cells, harvesting autologous adult cells entails the least risk and controversy.
Autologous stem cells are obtained from the patient’s own body; and since they are the patient’s own, autologous cells are better than both cord and embryonic sources as they perfectly match the patient’s own DNA, meaning that they will never be rejected by the patient’s immune system. Autologous transplantation is now happening therapeutically at several major sites world-wide and more studies on both safety and efficacy are finally being announced. With so many unrealized expectations of stem cell therapy, results to date have been both significant and hopeful, if taking longer than anticipated.
What’s been the Holdup?
Up until recently, there have been intense ethical debates about stem cells and even the studies that researchers have been allowed to do. This is because research methodology was primarily concerned with embryonic stem cells, which until recently required an aborted fetus as a source of stem cells. The topic became very much a moral dilemma and research was held up for many years in the US and Canada while political debates turned into restrictive legislation. Other countries were not as inflexible and many important research studies have been taking place elsewhere. Thankfully embryonic stem cells no longer have to be used as much more advanced and preferred methods have superseded the older technologies. While the length of time that promising research has been on hold has led many to wonder if stem cell therapy will ever be a reality for many disease types, the disputes have led to a number of important improvements in the medical technology that in the end, have satisfied both sides of the ethical issue.
CCSVI Clinic
CCSVI Clinic has been on the leading edge of MS treatment for the past several years. We are the only group facilitating the treatment of MS patients requiring a 10-day patient aftercare protocol following neck venous angioplasty that includes daily ultrasonography and other significant therapeutic features for the period including follow-up surgeries if indicated. There is a strict safety protocol, the results of which are the subject of an approved IRB study. The goal is to derive best practice standards from the data. With the addition of ASC transplantation, our research group has now preparing application for member status in International Cellular Medicine Society (ICMS), the globally-active non-profit organization dedicated to the improvement of cell-based medical therapies through education of physicians and researchers, patient safety, and creating universal standards. For more information please visit http://www.neurosurgeonindia.org/