Issue 20.17
The use of stem cells to aid the body in restoring damaged or destroyed tissue is one of the more promising areas of medicine today. Numerous studies are being conducted within the United States and abroad to attempt to determine how to best use these therapies, many of which offer the potential to treat diseases for which few treatments exist. However, as with any new therapy, there are risks associated with these treatments, and patients should be cautious when evaluating them.
When a patient is considering a potential therapy, an important question to ask is whether the therapy is FDA approved, meaning that the therapy has been tested in clinical trials and has been found to be both safe and effective, which adds a layer of protection for patients. When a therapy is not FDA approved, it has either not been evaluated sufficiently to allow for approval, or the therapy has been studied and been shown to be potentially harmful.
Many new or emerging therapies, including many stem cell therapies, are in the process of seeking FDA approval. This process varies, depending of the type of treatment being evaluated, but generally includes a series of clinical trials that demonstrate both safety and effectiveness of the treatment. The process of approval, designed to protect patients, can take years to complete and can be very expensive.
One of the challenges with a new therapy that provides great potential benefit is that, sometimes, the excitement surrounding the therapy outpaces the research that demonstrates its effectiveness, as has been the case with stem cell therapy. This can lead to patients’ receiving beneficial therapy prior to formal approval; however, it can also lead to patients’ participating in treatments that have not been shown to be safe or effective and, at times, at great cost.
The FDA has issued guidelines regarding the use of stem cells as well as tissue allograft material that may contain stem cells. It is important for any provider who performs biologic injections to be familiar with the FDA guidelines to ensure compliance. These guidelines will likely continue to evolve over the next several years as more research is conducted.
When considering undergoing a therapy that is considered experimental, a patient needs to fully understand the risks, benefits, and alternatives of the therapy prior to receiving the treatment. He or she should not hesitate to ask questions regarding the clinical evidence to support the therapy as well as what the potential risks may be. It would also be important for patients to discuss any experimental therapy with their primary care physician, who may be able to provide additional insight.
Physicians at Southwest Spine and Pain are currently involved in an FDA-approved clinical research study to determine the effectiveness of stem cell therapy in treating patients with lower back pain and lumbar degenerative disc disease. They are also familiar with the FDA guidelines regarding the use, including potential risks and benefits, of products that may contain stem cells that are currently in use. They would be happy to discuss any questions you may have.
Dr. Rick Obray received a Medical Degree from Johns Hopkins School of Medicine, completed residency training in Diagnostic Radiology at Johns Hopkins Hospital, and completed fellowships in musculoskeletal MRI at Johns Hopkins Hospital and Pain Medicine at The Mayo Clinic. He also has a Masters degree in Biochemistry from Utah State University. He is board certified in both Diagnostic Radiology and Pain Medicine.
Dr. Obray can be contacted at Southwest Spine and Pain Center 435-656-2424.