The Clinic for Molecular Orthopedic’s Treatment Stops
Joint Disease in Its Tracks
by Justin Handley
Orthopedic doctors in Germany have just taken a giant lead in the race for a cure for human osteoarthritis (OA) – and they have a stable of million-dollar racehorses to thank for it.
Over the past 10 years, the speedy steeds have provided researchers with a jackpot of knowledge about a new treatment that is now able to halt moderate-to-severe OA in human patients.
Called IRAP, this new biological therapy has eliminated crippling joint pain and inflammation in thousands of OA sufferers, as well as their need for drugs and even joint replacement and/or spinal surgery.
How Racehorses Helped Doctors
Solve the Riddle of Human OA
“Racehorses are the ideal research model because OA is so common among them,” explains Dr. Axel Baltzer of The Center for Molecular Orthopaedics, Königsallee Clinic (Gemeinschaftspraxis Königsallee) in Düsseldorf, Germany, one of the early pioneers in IRAP research on both horses and humans.
“Because of the horses’ high monetary value — and because standard treatments for equine OA are so ineffective — owners permitted us to experiment with IRAP, producing great results for them, along with valuable insights into human applications,” Dr. Baltzer explained.
More than 60% of lameness in horses is due to OA. And with 95% of their body mass (not including a rider) compressing the joints in their thin legs with crushing force as they run, it’s easy to understand why.
After years of clinical studies, IRAP has emerged as the cutting-edge treatment for equine OA. But the bigger news is how this has paved the way for official approval of IRAP for human treatment in Europe.
In clinical use now in Europe for the past eight years, IRAP is proving to be one of the most impressive weapons against human OA; the joint-destroying disease that is the second leading cause of disability globally.
How OA Happens
“IRAP” may sound like a vanity license plate on a hip-hop celebrity’s limousine, but in the world of molecular orthopedics, it stands for interleukin-l receptor antagonist (IL-1Ra), a super-hero protein with the ability to clobber the inflammatory bad guys that determine who will get OA and who won’t.
Normally, an injury to a joint or cartilage triggers the immune system to create inflammation, the first step in the healing process. In such cases, pain and immobility are temporary as the damage heals itself.
But if the injury is repetitive (like accumulated wear-and-tear friction) – and if there is a genetic tendency to develop OA — a state of chronic inflammation ensues in which a cascade of nasty inflammatory enzymes (called cytokines) can flood the joint and begin to permanently damage it.
Unchecked, the worst of these cytokine villains — interleukin-l (IL-1) and tumor necrosis factor-alpha (TNF) – “burn” into the smooth surface of cartilage that covers the ends of the bones in joints so they no longer glide freely against each other. The cytokines also increase sensitivity of nerve endings in the joint, causing intense pain.
As it is damaged, the cartilage surface becomes rough and uneven like sandpaper, which continues to wear away existing cartilage and perpetuates chronic inflammation. This dual assault of friction and cytokine erosion rapidly destroys existing cartilage — and ultimately the bone — until joint replacement is a patient’s only alternative.
OA is a vicious, downward cycle of progressive joint deterioration with increasing pain and immobility. Constant painkillers and anti-inflammatory drugs are needed to control the discomfort – and more desperate measures like steroid injections of cortisone are sometimes used before joint replacement or back surgery become inevitable.
Ironically, these drugs actually accelerate joint destruction by inhibiting the natural process by which the body repairs damaged cartilage.
IRAP Breaks This Destructive Cycle
IRAP therapy — also referred to as autologous conditioned serum (ACS) – breaks the stranglehold these destructive cytokines have on joints and in spinal vertebrae.
Currently available in Germany under different patented names like Onoccomed or Orthokine, these completely biological treatments (ACS) stop the inflammation cycle, block the destructive action of Il-1, TNF and other harmful cytokines, and alleviates OA pain – in many cases, permanently. For personal very good experience we do favor Onoccomed to Orthokine these days, although we are looking back to a long history of biological treatments based on Orthokine.
The Only Treatment That Halts OA
Biologic ACS (Onoccomed or Orthokine) is the first treatment that actually halts the progression of OA. By multiplying the body’s autologous (meaning “naturally occurring”) growth factors, ACS interrupts the inflammation cycle, thereby halting joint pain; while simultaneously stimulating the regeneration of collagen and cartilage in joints.
ACS (like Onoccomed or Orthokine) has helped restore mobility and comfort to thousands of OA patients who have traveled to Germany, where the treatments are currently available. Dr. Baltzer reports that virtually all of his ACS patients (Onoccomed or Orthokine) at Gemeinschaftspraxis Königsallee have been able to discontinue pain medications – with an impressive number delaying or completely avoiding joint replacement or spinal surgery.
“Typically, we see OA patients who haven’t responded well to conventional therapies and who were on the brink of surgical intervention,” Dr. Baltzer reports. “With ACS-treatment, they become more mobile and pain-free, with indications that some joints actually repair damaged cartilage.”
ACS (Onoccomed or Orthokine) can even be a “cure” for OA when used early enough, by halting the destructive cycle in its early stages before it can spiral out of control.
But ACS treatment (Onoccomed or Orthokine) has its limits, Dr. Baltzer explains. “The more severe the cartilage has been damaged, the less effective the treatments will be. But for the vast majority of OA patients in either Stage Two or Three, ACSs can be extremely helpful.”
The Only Treatment That Halts OA
Orthokine is the first treatment that actually halts the progression of OA. By multiplying the body’s autologous (meaning “naturally occurring”) growth factors, Orthokine interrupts the inflammation cycle, thereby halting joint pain; while simultaneously stimulating the regeneration of collagen and cartilage in joints.
Orthokine has helped restore mobility and comfort to thousands of OA patients who have traveled to Germany, where the treatments are currently available. Dr. Baltzer reports that virtually all of his Orthokine patients at Gemeinschaftspraxis Königsallee have been able to discontinue pain medications – with an impressive number delaying or completely avoiding joint replacement or spinal surgery.
“Typically, we see OA patients who haven’t responded well to conventional therapies and who were on the brink of surgical intervention,” Dr. Baltzer reports. “With Orthokine, they become more mobile and pain-free, with indications that some joints actually repair damaged cartilage.”
Orthokine can even be a “cure” for OA when used early enough, by halting the destructive cycle in its early stages before it can spiral out of control.
But Orthokine has its limits, Dr. Baltzer explains. “The more severe the cartilage has been damaged, the less effective the treatments will be. But for the vast majority of OA patients in either Stage Two or Three, Orthokine can be extremely helpful.”
From Horses to Humans
After its dramatic success on equine OA, researchers wondered if IRAC might be equally effective in humans. A group of German orthopedic researchers, which included Dr. Baltzer, were way ahead of the curve.
As early as 1997, the Düsseldorf-based firm Orthogen (the creators of equine Orthokine) had developed a method of creating an IRAP-rich serum for human patients from their own blood, which they injected into diseased joints.
Anecdotal results with long-term OA sufferers were extremely encouraging. Patients were emerging pain-free … mobility and comfort were restored … and joint replacement candidates were able to avoid surgery completely, or at least delay it for several years.
A New Breakthrough Treatment for OA
As a senior clinician at The Center for Molecular Orthopaedics, Königsallee Clinic, Dr. Baltzer was of the early innovators in the use of Orthokine treatment in human OA.
Due largely to the dramatic success he and his Gemeinschaftspraxis Königsallee colleagues have had, Orthokine is beginning to show up on radar screens outside of Europe, despite strong opposition from the conventional orthopedic sector and the pharmaceutical industry.
And scientific research is confirming Orthokine’s effectiveness. Results released in May, 2005 from a double-blind, placebo-controlled study conducted by Dr. Baltzer at the Heinrich Heine University in Dusseldorf, Germany, found that Orthokine provided significant improvement in patients with OA of the knee.
Four hundred patients with mild-to-severe knee OA were randomly divided into three groups. The first received Orthokine injections, the second were administered injections of hyaluronic acid (HA) – a popular treatment for OA in Europe and the US – with the third group getting placebo injections.
“Orthokine Is 100% More Effective’
“The Orthokine group reported an improvement in pain intensity of more than 50%, while the improvement in the HA and placebo groups was only 25%,” according to Dr. Baltzer.
A study of Orthokine’s success in the treatment of human back pain was released in July 2004. Research by Dr. Cordelia Becker of the orthopedic clinic at the Ruhr-University Bochum, Germany, found that Orthokine relieved pain as effectively as cortisone therapy, with the effects lasting considerably longer – and without the negative side effects and dangers of the steroid.
A synthetic version of IRAP therapy version was approved by the U.S. Food and Drug Administration in 2001 for the treatment of rheumatoid arthritis (RA) in humans. Marketed by Amgen under the name Kineret, it involves daily subcutaneous injections which decrease the pain and swelling of moderate to severe RA, though it is ineffective against OA.
How ACS (Onoccomed or Orthokine) Works:
Cartilage and bone are living tissues which exist in the continual process of destruction and regeneration called remodeling, so that new tissue and repairs can occur.
In bone, cells called osteoclasts breakdown bone to make calcium available so that osteoblast cells can utilize it to create new bone or repair breaks.
In cartilage, cytokines (chemicals secreted by the immune system to attack infections breakdown damaged or dying cells) control this same balancing act. Interleukin-1 (IL-1) is the cytokine responsible for the breaking down of cartilage through normal inflammation and degeneration; while IRAP (interleukin-l receptor antagonist or IL-1Ra) and other “growth factors” regulate the reconstruction.
This continual turnover of the cartilage matrix is essential to healthy cartilage. But when chronic inflammation exists – and when there is a genetic predisposition toward OA — this delicate balance of breakdown and repair is thrown out of whack, favoring the side of destruction.
In a healthy joint, IL-1 is kept in check by a sufficient presence of IRAP. But when IRAP is in low supply (or IL-1 is in excess), these destructive cytokines can disrupt the molecular balance in joints. This causes pain, stiffness, inflammation and progressive damage to cartilage and bone in joints.
The result is the perpetuation of painful inflammation and the acceleration of cartilage erosion, or the disease state we call OA. Excess IL-l and TNF continue to destroy cartilage until bare bone grinds on bone, which creates even more inflammation, more cytokine production, more cartilage destruction and more pain.
OA then becomes a vicious, recurring cycle as damaged cartilage cells produce more interleukins and other cytokines that incite further inflammation, which break down cartilage even further.
When cartilage is finally gone, grinding friction and inflammatory agents begin to attack and destroy bone cells. This point is called Stage Four OA and surgical joint replacement is a patient’s only alternative.
How ACS (Onoccomed or Orthokine) Stops OA …
ACS (Onoccomed or Orthokine) is created by withdrawing blood from the patient into a large syringe containing specially treated glass beads. During a 24-hour incubation period, blood cells interact with the bead surfaces, simulating an immune response and prompting the blood to produce large quantities of IRAP, TNF and other beneficial anti-inflammatory compounds.
The syringes are then placed in a centrifuge to separate blood cells from the serum, which contains the boosted IRAP and other growth factors. Under three-dimensional x-rays (called computed tomography, or CT) the serum is injected into arthritic joints and/or problem areas of the spine.
Once in the problem area, ACS (Onoccomed or Orthokine) blocks the access of destructive IL-1 and TNF to the receptor sites on cartilage cells in the patient’s affected joint. The more IRAP and other beneficial growth factors present in a damaged joint, the less problem-causing cytokines such as IL-1 can harm it.
… and Actually Stimulates Joint Repair
ACS (Onoccomed or Orthokine) therapy is so exciting because of its’ potential for a long-term therapeutic effect on OA.
Whereas conventional treatments, such as anti-inflammatory drugs and steroids only have short-term effects(not to mention their serious side effects and health dangers), IRAP can actually stop the cartilage matrix from being degraded and stimulate its repair and true healing.
IRAP has the ability to stop the inflammation cycle and end the pain it causes for extended periods, if not indefinitely.
Typically, ACS (Onoccomed or Orthokine) treatments consist of daily injections for six days, with many patients experiencing significant improvement immediately. Because the serum is derived from the patient’s own blood – and a 100% biological substance — the possibility of adverse allergic of side effects is practically non-existent.
For some, one series of treatments is all that’s needed, while others may require follow-up treatments after one, two or three years, depending on how much cartilage has been destroyed by their OA.
Multiple Benefits over Conventional
Joint Replacement and Back Surgery
Many OA patients are turning to ACS (Onoccomed or Orthokine) injections because they are far less invasive, stressful and dangerous, compared to joint replacement or back surgery. There is no recuperation period required and it is an out-patient treatment taking less than 10 minutes, depending on the number of sites injected.
ACS (Onoccomed or Orthokine) allows the OA patient to “buy time” instead of being pushed into joint replacement or spinal surgery. This is important, because a new wave of orthopedic treatments is rapidly evolving and will be ready for use in a relatively short time.
Radically new OA treatments involving cartilage transplantation, “laboratory grown” cartilage implants, stem cell techniques and gene manipulation were unimaginable just a few years ago. But now they are been performed with unprecedented by cutting-edge European clinics like Dr. Baltzer’s Gemeinschaftspraxis Königsallee in Düsseldorf.
Besides the convenience, ACS (Onoccomed or Orthokine) injections are far les costly than surgery and the ensuing rehab process. A typical six-day treatment averages anywhere from US$8,000-15,000, which includes a comprehensive diagnostic analysis using the very latest scanning technologies.
But perhaps the most important benefit of biological/molecular/genetic solutions like those practiced by Dr. Baltzer’s group is because the cytokine imbalance underlying OA is not limited to a specific part of the body; but is a whole body phenomenon. This why, more often than not, OA patients replacing a particular joint usually need to replace another and another unless the inflammatory cascade can be halted. The same seems to be true for patients receiving surgical treatments for spinal OA.
ACP (Autologous Conditioned Plasma) for Tendon and Muscle Injuries
We are using also other autologous products like ACP (Autologous Conditioned Plasma), which has great potential in healing of tendon and muscle injuries. The use of ACP in partial tendon ruptures or chronic tendon degeneration became of major importance for us to avoid surgery of the Achilles tendon, and other tendons. ACP seems to superior to all other medications we know, including other biologics. This procedure has not only been tested in race horses, but is in use successfully for years in veterinary medicine. In different formulations, ACP is in use in the Centre for Molecular Orthopedics for about 10 years now. No major side effects have been seen ever since in our patients.
How Horses Are Helping Doctors Conquer OA
First demonstrated effective on racehorses in 2000, researchers constructed a benign virus that contained the equine IRAP gene sequence. When injected into horses’ diseased joints, it triggered the horses’ own DNA to manufacture more IL-1Ra.
Results showed decreased pain (measured by degree of lameness), reduced inflammation (measured by reduced joint fluid levels) and fewer disease-related changes to joint tissues. This was boon to the animals’ owners who often have several hundreds of thousands of dollars invested in an individual racehorse.
An early study of Orthokine treatment in racehorses with moderate and severe cartilage erosions and a poor chance for improvement was performed by Dr. Thomas Weinberger, DVM, of the Equine Clinic Burg Mueggenhausen (Germany). The results were impressive.
“Even with the poor prognosis after arthroscopy, the results showed 70% of the horses (walked and ran) without lameness and (went) back to training after the last follow-up Orthokine treatment,” he reported.
Further Studies Confirm Its Effectiveness
Orthokine is rapidly becoming the treatment of choice for horses with OA, outperforming hyaluronic acid (HA) or corticosteroids. Best results have occurred in horses that are non-responsive to other therapies and little chance for improvement.
Several other controlled studies have reported similar results. A 2005 study conducted at Colorado State University concluded that “horses treated with (IRAP) were observed to have significantly improved lameness in osteoarthritis joints (even) weeks after the last treatment compared with placebo-treated horses.”
Veterinarians now have a documented protocol for IRAP treatment, with more than 70 US vets offering it as of December, 2005. Worldwide, veterinary surgeons have used it for over three years without negative reactions or side effects.
 A research paper describing the serum production system was published in a 2003 issue of Inflammation Research.