“Our mission is to cure low back pain.”
Low back pain (LBP) is the number one cause of disability worldwide. An estimated 70 million Americans currently suffer from low back pain, costing our country >$250B annually in lost wages and treatment costs. While there are many causes of low back pain, the most common source is an injured intervertebral disc. Chronic lumbar discogenic pain (CLDP) affects an estimated 13 million people in the U.S. annually and is a vexatious problem for healthcare systems not only in the US, but globally.
Current treatments for CLDP—including drugs, surgery, physical therapy, and chiropractic care—are limited in their ability to consistently produce measurable sustained improvements in patients’ pain and function. In some cases, these treatments can leave patients in worse pain leading to chronic opioid use and prolonged disability. Drugs and surgery frequently fail to address the underlying pathophysiology of an injured disc.
We envision a spinecare paradigm shift away from these historic treatments and toward solutions stemming from the emerging field of regenerative medicine. Regenerative treatments not only offer the hope of a cure to low back pain, but also a potential sustainable solution to the economic burden this condition creates for most countries. The paradigm shift we envision involves moving away from costly hospital-based fusion surgeries toward outpatient intradiscal injections of the patient’s own healing cells into the injured areas of the disc. The value proposition is simple: better outcomes for less cost and less risk than historic ineffectual treatments.
This paradigm shift will only occur through well funded research analyzing both the safety and efficacy of Intradiscal Biologic Therapy (IBT). The Regenerative Sportscare Foundation Inc. (RSF) was created as a not-for-profit 501(c)(3) tax exempt corporation to raise monies to support these important research activities and help patients find safer more effective treatments for their CLDP.
Outcomes of intradiscal orthobiologics can be improved through changes made to the content of the cells injected or through improvements in precision cell delivery. Our current research focus is in both of these areas. If we can better quantify the cell injectate, we can then see if higher concentration of cells leads to improved outcomes. Additionally, right now our current method of delivery is a straight-needle technique. We believe more precise delivery of cells can be achieved by an improved delivery device that can coil inside the disc. Finally, since the major concern with any intradiscal injection is the risk for infection, we will be studying the effects of various cell preparations on inhibiting bacterial growth in culture. RSF is committed to finding the best cell injectate for the disc, the safest preparation to reduce the risk for infection, and the most optimal intradiscal delivery device. All of these advancements will improve outcomes of regenerative treatments in the spine and provide patients with chronic low back pain alternatives to spinal fusion surgeries.
Dr. Gregory Lutz is the Founder and Chief Medical Officer of the Regenerative SportsCare Institute/Foundation. In addition, he serves as Physiatrist-in-Chief Emeritus at Hospital for Special Surgery and a Professor of Clinical Rehabilitation Medicine at Weill Medical College of Cornell University. Dr. Lutz completed his medical training at Georgetown University School of Medicine, the Mayo Clinic, and Hospital for Special Surgery, where he has been in practice since 1993. Dr. Lutz has pioneered innovative interventional orthopedic approaches in the treatment of musculoskeletal injuries. In 2016, he created the Regenerative SportsCare Institute/Foundation, with the intention of creating a sustainable model of musculoskeletal care that focuses on interventional orthopedic procedures coupled with regenerative treatments. RSF is the non-profit entity established to fund clinical outcomes research of these procedures and related basic science studies. He has published over 50 research articles and book chapters in peer reviewed journals. He is also a founding board member of the Interventional Orthopedic Foundation.
Low Back Pain Epidemic
Low Back Pain (LBP) is the leading cause of disability both worldwide and in the US, affecting as many as 70 million Americans today. An estimated 80% of Americans will experience LBP in their lifetime. In 2015 the Global Burden of Disease (GBD) reported that the global point prevalence of activity-limiting LBP was 7.3% (540 million people in the world), and LBP is now regarded as the number one cause of disability globally.These authors concluded that LBP must be a priority for future research on prevention and treatment.
The annual hospital costs to treat LBP in America are estimated to be $150B. Combined with the $103B in estimated lost annual earnings for Americans with LBP—who miss a collective 291 million workdays per year—that brings the total estimated annual cost of LBP in America to $253B, an amount greater thay the money spent annually on treating cancer, coronary artery disease, and AIDS combined.
Roughly ½ of the 70 million Americans with LBP have chronic low back pain, defined as pain that has persisted for >3 months. Of the 30 million Americans with CLBP, an estimated 13 million suffer from CLDP—pain caused by pathology (injury) of the intervertebral discs in the spine. CLDP is the most serious and difficult to treat form of LBP—the kind that doesn’t normally resolve on its own. As such, it is the focus of our efforts as physicians.
Causes of Low Back Pain
The causes of low back pain (LBP) are multiple. Like all tissues, the human spine deteriorates with age and injury, which can lead to debilitating pain for certain individuals. LBP is most often caused by structural defects in the tissues of the spine—strained ligaments, muscles, and/or injured discs—that present themselves overtime and are associated with cell-mediated changes. These changes can be exacerbated by previous intervertebral disc trauma with resulting LBP, often referred to as internal disc disruption (IDD).
Underlying causes of disc degeneration include genetic inheritance, age, unhealthy lifestyle habits, inadequate metabolite transport, and loading history, all of which can weaken discs to such an extent that structural failure occurs during the activities of daily living. Structural
Underlying causes of disc degeneration include genetic inheritance, age, unhealthy lifestyle habits, inadequate metabolite transport, and loading history, all of which can weaken discs to such an extent that structural failure occurs during the activities of daily living. Structural defects, such as endplate deterioration and fracture, radial fissures, and herniation, are unambiguous markers of impaired disc function leading to structural failure. Structural failure has historically been considered to be irreversible because adult discs have limited innate healing potential, due to their limited vasculature (thus limiting the presence of healing growth factors, stem cells, and platelets, which serve to heal and repair injured tissue).
Current Treatments and Limitations
Historically, CLDP has been one of the more difficult musculoskeletal conditions to treat.
Common approaches—including surgery, pharmaceuticals, physical therapy, chiropractic care, and alternative remedies—have typically been associated with only modest improvements in patients’ pain and function at best, and—more typically—minimal effects, or even greatly increased pain and diminished function overtime.
Physical Therapy, Yoga, and Chiropractic
Physical therapy, exercise, and yoga aim to reduce LBP by focusing on strengthening and stretching the muscles of the core, low back, and pelvis, in order to place the spine in extension. By strengthening certain muscles and stretching others, physical rehabilitation aims to help the patient extend and support the spine, thereby supposedly taking pressure off of the injured disc to give it room to heal on its own. Spinal manipulation aims to accomplish this same extension of the low back by manipulating the vertebrae into proper alignment.
The problem with treating CLDP with rehabilitation alone is that—just like a punctured car tire won’t re-inflate itself if the pressure of the car’s weight is reduced—intervertebral discs will rarely heal on their own, no matter how much pressure is relieved, due to their poor inherent healing potential. To date, no studies have shown physical therapy, exercise, yoga, or spinal manipulation to be more than very mildly effective in treating chronic discogenic LBP.
Medications, such as opioids, target LBP by attaching to pain receptors in the brain and thereby temporarily masking the sensation of pain. Overtime, however, the brain becomes accustomed to the analgesic effects of painkillers, and higher and higher doses are required to stave off the pain, often leading to addiction. Eventually, these medications become ineffective, and a patient is left with even worse pain.
In randomized trials, nonsteroidal anti-inflammatory medications were shown to be only marginally more effective in reducing patients’ LBP compared to a placebo, not to mention the side effects and risks that typically accompany the mild pain relief.
Currently, spine surgery is the most widely accepted ‘first line of defense’ treatment for CLDP that fails to respond to non-invasive, conservative treatment. Spine surgery targets CLDP by removing damaged tissue, and—in the case of a spinal fusion—introducing permanent metal hardware to stabilize the spine. The goal of instrumented spinal fusion surgery is not to repair the injured tissue, but rather to eliminate the mechanical contribution of the diseased part of the spine by permanently freezing its movement.
During an instrumented spinal fusion, the injured disc is removed and the vertebrae above and below the injured disc are fused together to form a bony union, for the purpose of limiting motion and reducing pain emanating from the disc. In order to keep the vertebrae stable, metal cages comprised of rods, hooks, braided cable, plates, and screws are implanted into the spine. The cages and accessory structures support the vertebral body, either between bones or in place of them, while new bone growth occurs through and around them. Alternatively, metal pedicle screws provide a means of gripping onto a vertebral segment and limiting its motion.
Concerns With An Instrumented Spinal Fusion
From a patient’s perspective, spinal fusion surgery presents several significant drawbacks.
For one, the surgery is expensive—costing upwards of $100K. But more importantly, it’s invasive, has a long recovery time, and is associated with relatively high rates of complication and low rates of long term success.
Spinal fusion surgery can negatively impact the mechanics of the spine in multiple ways. Fusing vertebrae together changes the patient’s range of motion in the spine, thereby increasing the stress load on adjacent joints and discs. This can sometimes result in a cascade of pain and disc pathology down the spine, often leading to further fusion surgeries. An additional risk is that the vertebrae do not fuse together properly during the surgery, which can necessitate a repeat surgical intervention.
Trauma caused by fusion surgery can also result in ongoing myofascial pain, the creation of fibrotic tissue that entraps nerves, and/or nerve damage, resulting in pain, sexual dysfunction, loss of leg strength and sensation, and/or loss of bowel or bladder control. Finally, there are risks involved with the medical instrumentation. Pedicle screws can break, become infected, or become loose, requiring further surgery to remove or revise the screws and rods. Grafts and cages can migrate or subside, which may also require repeat spine surgery.
The direct and indirect costs of spinal fusion surgery are extraordinarily high, as is the potential for complications. Meanwhile, data and clinical experience suggests spinal fusion surgery is even less effective than conservative approaches in treating CLDP, which are themselves not very effective.
A randomized trial compared the outcomes of patients who underwent spinal-fusion surgery with patients who underwent an aggressive rehabilitation program (64 patients with CLDP).
No differences in function, pain, medication use, work status, or general satisfaction between the groups were reported at one year. After one year, 33 percent fewer patients in the fusion group returned to work than did those in the rehabilitation group.
Finally, recent clinical studies have demonstrated that the rate of infection correlated with spinal fusion surgery is significantly higher than was previously estimated. In one prospective study of 50 patients at the Hospital for Special Surgery, leading spine researchers cultured the surface of spinal implants that had been removed from patients who had experienced persistent post-surgical pain. After discovering bacterial contamination in 38% of the patients’ implants, the authors concluded that subclinical (occult) infections are a major and underreported cause of failed fusion surgeries and likely account for a large portion of the reported poor outcomes whose cause had previously been unknown.
Epidural Steroid Injections
Epidural steroid injections aim to address CLDP by delivering anti-inflammatory, pain-relieving steroids to the site of the injured disc. In contrast to opioid medications, which block pain receptors in the brain, steroid injections deliver a high dose of anti-inflammatory medication directly between the disc and the inflamed nerve endings. While this help the pain, it doesn’t lead to healing.
Epidural steroid injections have historically been one of the most effective treatments for discogenic LBP that does not respond to conservative treatment measures, although they do not work for every patient. For patients who do experience reduced pain and restored function, the effects of an epidural injection tend to wear off overtime—and multiple injections are often needed.
In the end, an epidural injection may help some patients experience significant pain relief for a period of months, or even years. But eventually, the pain almost always returns, because the underlying injury is never healed.
Why Do Most LBP Treatments Fail?
Unlike skin, which has a good supply of circulation and can therefore heal quickly—growth factor-rich stem cells and platelets travel through the circulatory system via blood to repair skin wounds at the surface—the intervertebral discs of the spine have limited blood flow and therefore poor inherent healing potential. This is a key distinction.
When a disc degenerates or is injured, tears in the outer disc wall—called the annulus—lead to a leakage of disc fluid. In the same way that a punctured or frayed tire loses its ability to function when deflated, a ‘leaky disc’ loses its ability to properly function when fluid leaks from it, and it becomes very painful.
The lack of a good blood supply to the disc limits the quantity of healing cells that can access the tear to repair it via natural mechanisms. This negative loop leads to further degeneration of the discs—and increased pain and disability overtime. Traditional treatments typically fail to heal patients’ CLDP because none of the current treatments on the market actually addresses the underlying disc pathology: the leaking tears in the annulus of the disc.
Rethinking The Natural History: CDLP Rarely Resolves on Its Own
One of the underlying assumptions behind conservative approaches to the treatment of CLDP is that discogenic low back pain will usually resolve on its own. In reality, this is a misconception.
In a survey of 589 patients with CLDP, 54% reported >10 episodes and 19.4% reported >50 episodes in their lifetime. In addition, pain typically worsened over time. The researchers concluded: “Collectively, our findings, and those of other studies, indicate that it may be inaccurate to characterize LBP as having an excellent prognosis. Recurrences are frequent and are often progressively worse over time.” Our clinical experience confirms the report’s findings.
This data suggests that for cases of true chronic discogenic low back pain, conservative treatments and surgical and pharmacological interventions, alike, are unlikely to produce real lasting change in a patient’s levels of pain and function. To reiterate, CLDP currently affects an estimated 13 million Americans, or roughly 40% of all individuals with chronic low back pain in the US. That means that 13 million Americans who are suffering from pain due to disc pathology are currently being presented with treatments that are grounded in faulty science and are unlikely to work, perhaps even doing more damage in the long-run. The bottom line is: drugs, surgery, manipulation, and rehab, alone, are not—and will never be—the cure for discogenic low back pain.
Conclusion on Current Treatments
From our perspective, the current treatment of chronic LBP is a microcosm of much that is wrong with our current healthcare system. The needs of the patient have been lost in an industry-driven environment where hospitals, medical device companies, and surgeons offer risky, unproven treatments that many times leave patients worse, not better. In the absence of effective treatments, many patients with LBP suffer not only from their original back pain, but from treatment complications. More than 20% of LBP patients remain on long-term opioid therapy, often due to complications from failed surgery.
There is a need for a radical change in how we treat LBP, what we refer to as the “SpineCare Paradigm Shift,” a transition from the concept that pain is generated by “instability,” thus indicating the “need” to fuse the spine, toward the concept that the disc has an “unhealed wound” that should be treated with only an injection of the patient’s own cells.
A Clinical Unmet Need for Effective Low Back Pain Treatments
The SpineCare Paradigm Shift
A shift is beginning to develop in the treatment of low back pain. Clinicians are quickly realizing that drugs, surgery, and conservative measures are not working. CLDP patient outcomes are generally poor, and insurance payors and patients are beginning to catch on.
In 2011, Blue Cross and Blue Shield of North Carolina announced they were excluding coverage for spinal fusion surgery for degenerative disc disease. This was in response to a 50% increase over a 5-year period in the costs for the surgery, despite the data and patient outcomes revealing its mediocre performance. Given rising costs and growing awareness—regarding both the complications and poor outcomes associated with spinal fusion surgery, as well as the promise of innovative non-surgical alternatives—this trend is likely to increase in the near future.
“It may be that financial disincentives accomplished something scientific evidence alone didn’t. It’s important to ask, why did the ‘need’ for fusions drop suddenly?”
—Dr. Richard Deyo,
Kaiser–Permanente Endowed Professor of Evidence-Based Medicine,
OHSU Family Medicine
Poor clinical outcomes, high costs, high morbidity, prolonged lost time from work & play, and patient dissatisfaction are driving the demand for less invasive, more effective solutions.
It is clear to us that we are living on the brink of a paradigm shift in orthopedics—a transition away from highly-invasive surgeries and pharmaceuticals, towards more effective, minimally-invasive regenerative treatments that support and amplify the body’s innate ability to heal itself. The problem is that in order for this shift to occur we need data proving that IBT is an effective & safe treatment with long term benefit. Solid clinical outcomes data will drive this shift and resources need to be allocated to support this.
Regenerative Medicine in the US
US Food and Drug Administration
The US Food and Drug Administration (FDA) regulates medical products, and cellular therapies are included in their jurisdiction, within the category of human cells, tissues, and cellular and tissue-based products (HCT/P). There are several types of HCT/Ps legally available for use in the US; some are regulated like a drug and others are not. Certain requirements must be met for HCT/Ps to fall into the category of products that are not considered as drugs.
The FDA has approved the use of autologous (the patient’s own) biologics derived from patients’ own blood, bone marrow, or adipose tissue that are then injected at point of care service. This means these cells can be harvested and then given back to the patient the same day with only minimal manipulation of the cells.
What is Cellular Therapy?
Platelet-Rich Plasma (PRP), Bone Marrow Aspirate (BMA), and Centrifuged Bone Marrow Aspirate (cBMA) are autologous cell-based products available for use in the US. There are overlaps between these different cellular therapies, also called biologics, but each is unique. The unique qualities and abilities inherent to each biologic can be matched to the unique characteristics of various diseases/injuries in order to more effectively treat them.
In other words, PRP is typically more effective at treating certain injuries than others, as are BMA and cBMA. What this means is that a strong clinical and scientific understanding of these biologics is important for any clinician to have—in order for them to make an informed choice about which cellular therapy to use for a patient’s condition(s).
Platelet-Rich Plasma (PRP)
PRP is obtained from a blood draw. Once the blood is drawn from the patient and placed into a single-use collection system, it is loaded into a centrifuge where it is rapidly spun, in order to separate aged red blood cells from other cells, platelets, and plasma. It is then injected directly into the injured tissue under ultrasound or fluoroscopic guidance to promote healing and repair. Depending on the injury, this process can take up to 1.5 hours.
PRP contains various growth factors that assist cells in the regenerative process. By definition, it has a high concentration of plasma and platelets and tends to be higher in platelet count than BMA or cBMA (but lower in mesenchymal stem cell count).
Platelets play an important role in the repair and regeneration of tissue. Platelets are well known for their hemostatic properties and, in cooperation with other nucleated cells found in peripheral blood, cooperatively produce a milieu of growth factors to recruit marrow stem and progenitor cells to the site of injury through the SDF-1-CXCR-12 ligand binding sites and through chemotaxic growth factors such as VEGF. Concentrating platelets and mono-nucleated cells by removing red cells and plasma (PRP) can improve this biologic response.
PRP also contains plasma, primarily composed of water with a milieu of dissolved proteins called precipitated proteins, which play an important role in tissue regeneration by providing proteins for regulating gene expression, modulation of the immune system, blood coagulation, and maintenance of colloid osmotic pressure. They are known to be anti-inflammatory and facilitate relief in an environment of chronic pain.
PRP is effective in areas in which cells can be recruited through the vasculature, the body’s highway system for repair. Additionally, PRP can be beneficial in regions in which vascularity is minimal (e.g. intervertebral discs ) because of various factors that are emitted from the platelets and cells.
Bone Marrow Aspirate (BMA) and Centrifuged Bone Marrow Aspirate (cBMA)
BMA and cBMA are obtained from a small amount of bone marrow, typically drawn from the iliac crest. The bone marrow can be used with or without centrifugation; BMA can be acquired through certain technologies that may or may not make centrifuging it a necessity.
BMA and cBMA both contain platelets, but not as much as is found in PRP. However, BMA and cBMA contain more cells with stronger regenerative potential than those found in PRP, including mesenchymal stem cells, a type of multipotent cell that can differentiate into a wide variety of tissue types, including bone, muscle, tendon, and cartilage.
A distinction between the utility of PRP versus BMA or cBMA can be the ability to draw cells toward the injured/diseased tissue. For example, if the injury is large or the disease too severe, it may make sense to utilize BMA or cBMA rather than PRP. Further research is needed to investigate this supposition.
Intradiscal Biologic Therapy: Offers Hope For a Cure to LBP
Intradiscal biologic therapies (IBT) are injections that deliver autologous biologics to an injured intervertebral disc, with the goal of healing or repairing the damaged tissue. Aside from the cell harvesting process, these procedures are largely the same. Growth factor-rich PRP, BMA, or cBMA is harvested from the patient, sometimes processed in a centrifuge, and then injected moments later—under C-arm fluoroscopic (low-dose x-ray) guidance—into the injured site. IBT is an outpatient procedure that takes about one hour from start to finish.
For many patients, IBT offers significant pain relief and improvement in function. These procedures are not risk free, but are much safer and more efficient—when compared to any spinal surgery.
We have now helped over 500 patients avoid more aggressive spinal fusion surgery and long-term opioids through the use of orthobiologics. Many patients have experienced, not only had long standing pain relief and functional improvement, but also evidence of actual disc healing on repeat MRI exams. These outcomes are unprecedented, given the fact that CLDP is a condition that was previously thought to be incurable. The majority of spinal fusions performed in this country >700,000 per year have been to treat these exact patients. Think about not only the reduced risks and improved clinical outcomes these treatments can provide, but also the huge cost savings if spinal fusion surgery can be avoided.
Case Study 1
Years ago, a 50 year old woman came to us with 3 years of CDLBP due to a disc protrusion. We administered one intradiscal PRP injection.
By 2 months post-procedure, her self-reported pain was significantly reduced, and her function had also improved. Following up with her three years after the procedure, she reported continued 100% pain relief and complete return to function.
Case Study 2
A 45 year old marathon runner came to us with a 2 year history of refractory CDLBP wanting to avoid undergoing a spinal fusion. The patient presented with Grade IV annular fissures and disc degeneration at the L-4,5 (mild) and L-5/S-1 (severe) levels, as well as Modic Type I endplate changes at L5-S.
We injected intradiscal PRP at both levels and, once again, the patient experienced significant pain relief. One year later, the patient remains significantly improved with return to full sporting activities and activities of daily living, with no morning stiffness.
What’s more impressive is that MRI images 9 months post-procedure—from the same patient and magnet—revealed reversal of Modic changes and increased T-2 signal (whiteness) at both levels, which indicates increased water content in the disc and is proof that the disc tears healed (disc regeneration).
Case Study 3
Unpublished data from a 36 year old male patient of ours with a long history of CLDP and radiating leg pain since 2011. His original MRI revealed degenerative disc disease with protrusions at L-4,5 and L-5/S-1. He had been treated conservatively with rehabilitation and epidural steroid injections with no significant improvement.
In 2013, he returned for a repeat MRI, which showed worsening of the protrusions. Surgeons recommended a 2 level instrumented fusion for his chronic refractory pain.
In 2014, he opted for IBT at both levels. By 3 months post treatment, he had achieved near complete pain relief and had returned to all sports.
A few years passed, and we hadn’t heard from him. One day in 2017, he came to our office with his wife who wanted regenerative knee treatments, and we asked him how he was doing. He had maintained his levels of improvement 3 years post injection, so we asked him to repeat his MRI 3 years post IBT and the findings we saw were remarkable: not only disappearance of the protrusions but increased water content (whiteness) of the lower two discs. This is a finding we had never seen before in 25 years of clinical practice.
The recoveries reported in these case studies of three patients were remarkable in their own right. That being said, we’ve now treated hundreds of patients with IBT and the results can be summarized as: approximately ⅓ of the patients near complete improvement, another ⅓ significant partial improvement and the remaining ⅓ mild or no relief. So there remains significant room for improvement with IBT.
Given that clinical experience only goes so far, we decided to test our patients’ outcomes against the strict standards of a double-blind randomized controlled study.
Supporting Clinical Outcomes Data
Lumbar Intradiscal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study
While these cases are impressive and show possible proof-of-concept, clinical outcome studies are needed to truly evaluate the potential safety and efficacy of these treatments. Through the donations of grateful patients we were able to perform a landmark study at the Hospital for Special Surgery, on the effects of intradiscal platelet-rich plasma (PRP) therapy on 49 patients suffering from CLDP that was unresponsive to conservative care for an average of 4.5 years. What we found was that in the treatment group 60% of patients reported improvement vs. only 18% in the control group. We then followed these patients out for 2 years and the benefits were maintained in the majority of patients.
We even continued to follow these patients out for a range of 5 to 9 years and 71% of patients reported continued improvement long term. There is no other spinecare treatment that we know of that has both double-blind and long term data like this. This improvement effect was from a single treatment, a “first out of box” cell preparation that can be optimized with further research.
Our goal is to maximize the autologous point-of-care cell preparation to the specific degree of disc disease in order to achieve a greater than 90% success rate consistently that can be maintained long term. This will require fastidious on-going intradiscal biologic research.
Autologous bone marrow concentrate intradiscal injection for the treatment of degenerative disc disease with three-year follow-up.
Dr. Kenneth Pettine et al. studied the effects of intradiscal bone marrow concentrate (BMC) therapy on 26 patients suffering from degenerative disc disease who were candidates for spine surgery, with three year follow-up.
At 3 years out, only 6 patients went on to spinal fusion surgery. The other 20 patients had average ODI and VAS improvements from 56.7 ± 3.6 and 82.1 ± 2.6 at baseline to 17.5 ± 3.2 and 21.9 ± 4.4 after 3 years. No adverse events related to the procedures were reported.
Intradiscal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study.
Dr. Christopher Centeno and et. al studied the outcomes of 5 patients with degenerative disc disease who had received an intradiscal injection of autologous, hypoxic cultured, bone marrow-derived mesenchymal stem cells 4-6 years prior. The researchers administered a physical examination, analyzed the MRI, and asked the patients to fill out a quality of life questionnaire.
No adverse events were reported due to the procedure. All 5 patients reported overall improvement, as well as post-procedure improvement in strength; 4/5 patients reported improvement in mobility. While interesting results, anything more than minimal manipulation would require an expensive FDA trial which isn’t feasible given the results we are seeing with point-of-care IBT.
How Do We Improve Outcomes and Safety With IBT?
Given our personal clinical experience and the growing body of data that is beginning to support intradiscal orthobiologics, we believe there is great hope for patients suffering from this disabling condition where drugs and surgery have fallen short of patient expectations.
However, it is important to note that despite good success for many patients who have received treatment, there is still a large gap in our knowledge. Future studies need to include quantification of the injectate to see whether or not increasing concentrations of cells injected actually leads to improved outcomes. What are the ideal cell preparations for varying degrees of disc disease? What are the safety concerns and how can we mitigate the risk of working in the intradiscal environment that is prone to infections? How can we achieve a success rate greater than 90%?
Our mission is to find a cure to low back pain, the number one cause of disability, not just in the US but in the world. We feel that regenerative medicine offers the hope not only of providing a potential cure, but also a more sustainable means of managing this costly disease.