SCOTTSDALE, Ariz. (Ivanhoe Newswire) - One in three people in the U.S. suffers with chronic pain. It affects more Americans than diabetes, heart disease, and cancer combined. Non-invasive treatments in the past have been limited, but now stem cells could hold the key to the future of pain management.
Bobby Sydnor and his band have something to sing about.
Bobby may have found the answer to his debilitating pain from a motorcycle accident 40 years ago that nearly crushed his spine, leaving him with three degenerative discs.
"It's just excruciating. I remember sometimes crawling to the bathroom," Bobby Sydnor told Ivanhoe.
Now, thanks to a cutting edge therapy, the bonsai enthusiast is finally getting some relief without surgery.
"It really has the potential to change the disease state, instead of just treating the symptoms," Tory L. McJunkin, MD, Principal Investigator at Arizona Pain Specialists, told Ivanhoe.
Dr. Tory McJunkin is involved in a multi-center clinical trial that's using stem cells to regenerate discs in the spine.
"They have the ability to change and to regrow that tissue until it's a normal tissue," Dr. McJunkin said.
Preclinical studies on sheep showed their discs were regenerated
"The treated disc looks exactly the same, you can't tell a difference at all and the untreated disc is very degenerative, very black," Dr. McJunkin said.
Full human trial results will not be available until later this year, but in early data 71 percent of patients who received a low dose of stem cells showed a significant reduction in low back pain and improvement in function, compared with 20 percent of patients in the control group.
Now, two years into the study Bobby said he's definitely feeling a difference and can't wait for what's next.
"I'm thankful for that, truly," Bobby said.
Fifteen sites across the country are conducting the trials. Full results from the phase 2 trial are expected in the third quarter of this year. The stem cells do not come from human embryos. Instead, they're harvested from healthy adult donors.
BACKGROUND: Back pain affects 80 percent of Americans at some point in their lives. In fact, back pain problems are the most common physical complaints among American adults and are a leading cause of lost job time. It can include sore tendons and muscles, fractures, herniated discs, and other problems. The most common back pain causes include nerve and muscular problems, arthritis, and degenerative disc disease. It is important to understand that back pain is a symptom of a medical condition; it is not a diagnosis itself. (Source: www.webmd.com)
MEDICAL PROBLEMS: Medical problems that cause back pain can include:
Injuries—Spine injuries, like fractures and sprains, can cause short-lived or chronic back pain. Sprains are tears in the ligaments that support the spine, and they occur from lifting improperly. Fractured vertebrae are often from osteoporosis. Accidents and falls are also causes of back pain.
Mechanical Problems—A mechanical problem is because of the way the spine moves or the way you feel when you move your spine in certain ways. One of the most common mechanical causes of back pain is a condition called intervertebral disc degeneration, meaning that the discs between the vertebrae of the spine are breaking down with age. (Source: www.webmd.com)
TREATMENT: Most back pain gets better with home treatment and careful attention. A short period of bed rest is recommended, but too many days can actually do more harm than good. When it is more severe, physical therapy is the cornerstone of back pain treatment. A physical therapist can apply a variety of treatments, like ultrasound, heat, electrical stimulation, and muscle-release techniques. If that doesn't work, injections are another option. The doctor may inject cortisone into the space around the spinal cord. (Source: www.mayoclinic.com)
NEW TECHNOLOGY: For some patients, traditional treatment just doesn't work. So, one of the newest breakthroughs in managing back pain is coming from stem cells. A company called Mesoblast released the latest news in a string of studies examining the ability of a specific type of stem cell to treat back pain. In the earliest tests, the company injected mesenchymal precursor cells (MPCs) into three adjacent lumbar discs in 24 adult male sheep. The sheep were injected with chrondroitinase in order to mimic disc degeneration and other discs were left alone. The degenerated discs had 45 to 50 percent less height before treatment with MPCs. After the discs were injected, they rehydrated and increased in height at statistically significant rates. Mesoblast has now released its second round of preliminary results from a phase 2 human study. For this phase, researchers injected allogeneic MPCs into damaged intervertebral discs. Researchers at IPM Medical Group in Walnut Creek, California; The Spine Institute in Santa Monica, California; Carolina Neurosurgery & Spine in Charlotte, North Carolina; Arizona Pain Specialists in Phoenix, Arizona; Virginia I-Spine Physicians in Richmond, Virginia, and Emory Orthropaedics & Spine Center in Atlanta, Georgia, report that a single low-dose injection of MPC significantly reduced low back pain in the treated patients and did so at a statistically significant way when compared to the control group. The study has enrolled 100 patients in 13 sited in the U.S. and Australia. At the six month follow-up, 71 percent of patients who received a low dose of MPCs met the pre-specified treatment success criteria. Twenty and thirty percent of the patients in the two control arms who received hyaluronic acid and saline met the pre-specified success criteria. (Source: http://ryortho.com/breaking/major-study-update-stem-cells-ease-back-pain/) "Stem cell research within the disc is very exciting. It focuses on addressing the source of the pain, rather than solely the treatment," Dr. Tory McJunckin was quoted as saying. "As an interventional pain doctor I have seen incredible advances in the specialty during the past 10 years – and this study shows we are still at the tip of the iceberg for major advances in pain medicine." (Source: http://www.prweb.com/releases/2011/10/prweb8917784.htm)
Tory L. McJunkin, MD, Principal Investigator at Arizona Pain Specialists, talks about how stem cells could help back pain.
How big of a breakthrough would you say this is?
Dr. McJunkin: It is really a big breakthrough. It's super exciting because it has the potential to really change the way that we manage and the way that we treat disease states.
How did you get involved in it?
Dr. McJunkin: The study is by MesoBlast and it's a company out of Australia and basically it's for degenerative disc disease. We are diagnosing people who have painful degenerative disc and when they become painful there's very little right now that we can do to treat them. So, the idea on the study is to see if stem cells injected into the disc will help to change the disc and change people's lives.
What are the results so far in the animal studies?
Dr. McJunkin: The animal studies have been very impressive. Actually, they've created the model for degenerative disc disease. Also, they've injected different substances inside the discs. They've done a high dose stem cell, a lower dose stem cell, and then they've done the carrier molecule. They did this study on sheep, but the MRI's before and after you can't tell the difference on which sheep disc were treated with the stem cells and which ones weren't.
Are these stem cells reproducing these discs?
Dr.McJunkin: Exactly. That's what stem cells do. Stem cells have the ability to differentiate and to replicate themselves. So, when they're injected into an area, if that area is damaged they have the ability to change and regrow that tissue until it's a normal tissue.
What do you think the implications are?
Dr. McJunkin: I think the implications are huge. Not just for the spine and degenerative disc disease, back disease, even herniated disc, but other things that they're studying right now, like heart disease and diabetes. I think the potential is almost limitless.
How long have you been with Arizona Pain Specialists?
Dr. McJunkin: My partner and I founded Arizona Pain Specialists about six years ago and I've been practicing pain for seven years. This is probably the most exciting research study that we've done just because it has the potential to change the disease state instead of just treating the symptoms.
Are there any preliminary results that you can share with us?
Dr. McJunkin: Not really. I can talk about the animal study. The animal study was very exciting because it really did change the morphology of the disc. It actually changed the way that the disc appeared on the MRI. The radiologists were blinded; they couldn't tell the difference. After the disc was treated they really couldn't tell which disc was normal and which was diseased. We've completed the Phase II clinical study in the human study and the data is back with the FDA right now and will await the launch of the Phase III study coming up soon.
Is there anything that you can say about the length of time it takes for the disc to fully regenerate?
Dr. McJunkin: Right now, we just don't know. We don't know several different things, but that's one of the exciting things about this study. It is actually a controlled randomized study. So it compares placebo, injecting saline into a degenerative disc versus a higher dose of the stem cells versus a lower dose of the stem cells.
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