This is an article regarding Mesoblast's Phase 3 trial for low back pain at one of the clinics in St. George, Utah. I have highlighted some text in bold and underlined it. The link to the article is at the bottom.
Its nice to hear straight from one of the clinical trial sites. Enjoy..........
ST. GEORGE— About 4 million people in the United States alone suffer from chronic lower back pain generally due to disc degeneration as a result of aging, injury or genetics. The painful and sometimes debilitating condition known as degenerative disc disease often requires medication, therapy and possibly invasive and expensive surgery to treat the symptoms and keep pain at bay.
But a revolutionary stem cell therapy, now in its third phase of clinical trials, could potentially slow, halt or even reverse the progression of the disease and the Southwest Spine and Pain Center, 652 S. Medical Center Drive, Suite 110, in St. George has been selected as one of only a few places in the nation authorized to conduct the FDA approved, double-blind study.
The therapy, if successful, will make a huge leap forward in the way doctors are able to treat chronic lower back pain by delivering stem cells to the degenerating disc in a noninvasive manner that could actually treat the disease not just the symptoms and possibly eliminate the need for painful and costly surgery.
The clinical studies are testing a product developed by Mesoblast Ltd., a world leader in creating innovative cellular medicines. According to the company’s website, Mesoblast has established the industry’s most clinically advanced and diverse portfolio of cell-based products.
The Mesoblast website states:
All our clinical programs target significant, under-served therapeutic areas including cardiac diseases, spine orthopedic disorders, oncology and hematology diseases, and immune-mediated and inflammatory conditions.
Mesoblast has developed five programs, two of which are in active phase three studies or are phase three-ready, with the others in phase two of testing.
This image describes the Mesoblast system for creating stem cell therapy to be used in treating degenerative disc disease, location and date not specified | Image courtesy of Mesoblast, St. George News |
A spokesperson for Mesoblast said that in order to be phase three-ready, the phase two trial has to have proved the safety and efficacy of the product.
We are the real deal “We are the real deal,” the spokesperson said. “Once we put it in for approval it is better than the gold standard.”
The phase three trial of Mesoblast’s stem cells has the approval of FDA which is key, Dr. Rick Obray of Southwest Spine and Pain Center said adding that it means they are doing research the right way. Degenerative disc disease
“A disc is like a squishy donut,” said David Nunez, a clinical liaison for Mesoblast.
When the disc suffers damage – be it by aging, an injury or genetics – it compromises the disc’s ability to act as a soft cushion between the vertebrae and provide stability to the body, information from the Mesoblast Web page on the disease states.
Damage to the disc also causes an inflammatory reaction which causes chronic pain and functional disability. In the past, the patient’s options consisted of medication and therapy to treat the symptoms of the disease or, if they are at their last end, surgery.
If the trial is successful it will drastically change the way chronic back pain is treated
If the trial is successful it will drastically change the way chronic back pain is treated, said Nunez. Nunez cited two important factors that the stem cell therapy could potentially reduce or eliminate; one, it could reduce the need for addictive opiates taken for pain; and two. it could reduce the need for invasive and dangerous back fusion surgery.
Nunez said that back fusion surgery is typically a three-hour surgery that is very expensive and potentially dangerous, adding that most surgeries require a vascular surgeon on call in case an artery is nicked during the procedure. “I can’t talk enough about how our stem cells are going to revolutionize this arena,” Nunez said. How the stem cells work
The stem cell therapy is created in four steps:
Mesenchymal precursor cells are extracted from a healthy, adult donor
Antibodies with magnetic particles attached are introduced and bind to the cells; using magnets, the cells are then isolated and separated
The purified mesenchymal precursor cells are grown and expanded in the lab into billions of cells
The cells are divided in doses, frozen in vials and shipped to medical facilities for use in patients
The benefits of this method are many, including the ability to create thousands of doses for patients while keeping costs down. Another huge benefit, the Mesoblast spokesperson said, is that the cells don’t provoke an immune reaction so they are safe to use in almost all potential candidates.
The therapy is delivered by injection to the patient in a noninvasive outpatient procedure that generally takes about 20 minutes, the object of which is to reduce lower back pain caused by disc degeneration and increase function by ultimately repairing the disc.
This image describes the procedure for delivering stem cells to be used in treating degenerative disc disease, location and date not specified | Image courtesy of Mesoblast, St. George News |
“It is basically the holy grail to fix chronic back pain,” the Mesoblast spokesperson said. “We are harnessing the body’s own ability to heal itself.” Southwest Spine and Pain trial – participant enrollment
Southwest Spine and Pain Center has been chosen as a site among a small number of clinics in the nation and the only clinic in Utah that he is aware of, Obray said, to conduct the Mesoblast trial and the clinic practitioners are excited about the potential stem cells have to treat chronic lower back pain.
This will be one of the first treatments out there that doesn’t just treat symptoms “It’s exciting because, if this works, this will be one of the first treatments out there that doesn’t just treat symptoms but actually can restore health,” Obray said. “It can regenerate the disc and stop the disease process and kind of turn back the clock a little bit.”
The clinic is now enrolling candidates to participate in the study. The trial is a double-blind study and patients who are accepted will receive either the stem cell therapy or a placebo but neither the doctor nor the patient will know which one they are receiving, Obray said.
The trial participants will receive routine checkups over the course of a year and all expenses are covered by the study itself.
“What this means is that patients in this area have the opportunity to participate in one of the cutting-edge areas of research right now,” Obray said.
There are several criteria a candidate must meet before being enrolled in the trial. If you are an adult who has suffered from chronic back pain for more than three months and are otherwise healthy, you can learn more about qualifying for the trial by contacting Southwest Spine and Pain Center at telephone 435-656-2424.
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