Stem Cell Therapy for Lower Back Pain
During the trial patients are treated with a dose of immunoselected, culture-expanded, nucleated, allogeneic adult mesenchymal precursor cells combined with hyaluronic acid. A control group is also given intradiscal injections for low back pain caused by moderate Degenerative Disc Disease at a single level in the lumbar spine (L1 to S1). The control groups receive injections of either saline solution or hyaluronic acid without the stem cells. Two different doses of stem cell treatment for lower back pain are being assessed, one of six million and one of eighteen million stem cells plus the hyaluronic acid as a carrier to transport the cells to the disc’s center (nucleus pulposus).
Details of the Mesoblast, Ltd. Trial
As well as being placebo-controlled, the stem cell trial is double-blinded and randomized with both sets of injections given at the same time and assessed using the same time frame. This type of methodology and trial design makes it much more likely that the results are credible compared to anecdotal reports of stem cell therapy for back pain, or sloppily designed trials without a placebo control or randomization. Mesoblast Ltd. intends to evaluate the efficacy of the single stem cell injections for lower back pain using physical examinations, vital signs, the results of a variety of laboratory tests such as inflammation, immunological tests, and blood work, and also to note any adverse effects of treatment. Specific tests related to the participants’ lumbar spine degeneration include MRI scans at six months after the stem cell injection and to use the Visual Analog Scale to assess any effect on chronic lumbar back pain between one month and three years after the stem cell treatment.
Could You Participate?
This trial is hoping to recruit a hundred patients with chronic lumbar back pain from moderate degenerative disc disease at a single level. The study is taking place at multiple locations and will closely match all participants with suitable mesenchymal precursor cells so as to reduce the risks of immune system rejection. Patients eligible for the clinical trial must have had back pain due to disc degeneration for at least six months and have been unresponsive to conservative treatments within the last three months (this includes physical therapy for degenerative disc disease). Participants will need to be able to undergo assessment at various stages after the stem cell injections, namely at 1 month, 3 month, 6 months, twelve months, two years, and three years. Only those over eighteen are able to enrol in the clinical trial.
Diagnosed Degenerative Disc Disease
Not all patients with lumbar back pain are able to enrol in this trial as the researchers are looking specifically at the use of stem cells to treat degenerative disc disease. As such, participants will need to have been diagnosed with symptomatic degenerative disc disease determined through MRI in comparison to healthy discs or through a change in disc hydration. Those with or without annular fissure or contained disc herniation are eligible and the loss of disc height compared to an adjacent normal disc must be less than 30%. Low back pain is the primary target of the treatment and so participants in Mesoblast, Ltd.’s stem cell trial will only be accepted if their back pain is greater than their leg pain, with a score of at least 30 on the Oswestry Disability Scale.
Who Cannot Take Part in the Stem Cell Trial?
Unfortunately a variety of back conditions and other issues rule a large number of potential candidates out for this Phase I/II trial. It may be that success in this trial then leads to other applications of the stem cell treatment for lower back pain but currently those with nerve compression due to spinal stenosis or clearly herniated discs or sequestered spinal discs are ineligible for this study. Those with a history of neoplasm (in the previous three years) or active neoplasm are also ineligible, with the except of those with basal cell carcinoma. Patients with an intact disc bulge or focal disc herniation of more than 3mm at the level responsible for symptoms are excluded from participating, as are sufferers of lumbar spondylitis and other undifferentiated spondyloarthropathies. Prior back surgery on the symptomatic level also rules out participation in this stem cell trial as does any intradiscal injection procedure such as epidural steroid injections or injections of glucosamine and chondroitin for back pain.
There are a number of other considerations for those looking at taking part in this trial including allergies to the injection material, murine, or bovine products, and even a history of alcohol or drug abuse, or prior participation in a stem cell trial. Those who do fit the criteria and are enrolled in the study may be treated in the following locations, mostly in the United States:
- Scottsdale, Arizona, at the Arizona Pain Specialists clinic
- University of California Davis Spine Center
- Santa Monica at the Spine Center
- Walnut Creek, California, at IPM Medical Group Inc.
- Denver Spine in Colorado
- Rocky Mountain Associates in Orthopedic Medicine, P.C., in Loveland
- Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina
- Emory University School of Medicine, Atlanta, Georgia
- Richmond Bone and Joint Clinic, Texas
- Memorial Hermann Medical Group, Richmond, Texas
- Central Texas Spine Institute, Austin, Texas
- Virginia Spine Research Institute, Inc.Richmond, Virginia
- Washington Center for Pain Management, Edmonds, Washington
- The Center for Pain Relief, Inc. Charleston
- Tallahassee Neurological Clinic, P.A.
- Monash Medical Center, Clayton, Victoria, Australia
This stem cell study could change the face of back pain treatment and help many avoid the need for invasive surgical procedures such as discectomy, laminectomy, and spinal fusion. Whilst there is little evidence that stem cell injections into the peripheral circulation have any specific effect on back pain or degenerative spine diseases this type of targeted treatment could reduce symptoms by lowering inflammation and triggering a regeneration of the spinal discs. Participating in this innovative Mesoblast trial does not guarantee that you will become back pain-free, but could help researchers get a little closer to finding the coveted stem cell cure for back pain.