Transcript Orthokine / Regenokine

Orthokine
Alison Pruzan, Sam Bresnick and Andy Willcock
May 1, 2013
Biomaterials
Osteoarthritis
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Orthokine is most commonly used to treat
Osteoarthritis
The mechanical reason for this is:
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As the articular cartilage thins out more and
more, it is incapable of shock absorbance
which leads to pain and loss of mobility.
Affects every joint, ESPECIALLY knee hip, and
vertebrae
 Especially prevalent in knee repairs
(Meniscus & ACL)
50% of everyone over age of 50 show
degenerative joint disease in their x-rays
After age 70, approx. 100% of the population
suffer from osteoarthritis
Besides the aging process, other factors such
as joint deformity, extreme wear and tear,
obesity, injury and genetic predisposition lead
to the onset of osteoarthritis
Biologically: the mediators of our immune
system, such as Interleukin-1 (IL-1), are
responsible for the degenerative changes of the
articular cartilage. The earlier the treatment
occurs, the better it is.
Treatment Options
 Pain / Inflammation
Medication
 NSAIDs
 Opiates
 Surgical Options
 Joint Replacement (invasive)
 Non-Surgical
 Platelet Rich Plasma
Injections (PRP)
 Regenokine/Orthokine
PRP vs. Orthokine
http://www.regenexx.com/wp-content/uploads/2012/07/orthokineregenokine.jpg
Main difference is the heating of the blood to illicit a “fever-like” response that
increases the concentration of anti-inflammatory proteins instead of just
platelets
Orthokine Background
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Pro-inflammatory cytokines play a pivotal role in osteoarthritis,
 Have also been seen to cause bone tunnel widening after ACL reconstructive surgery.
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Orthokine administers autologous conditioned serum (ACS) containing endogenous antiinflammatory cytokines including IL-1Ra and growth factors (IGF-1, PDGF and TGF-ß1,
among others) in the liquid blood phase.
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This works, because in osteoarthritis, the body produces interleukin-1 (IL-1), a protein
that contributes to the breakdown of cartilage. To slow down or stop this process, the
biological adversary of IL-1, the interleukin-1 receptor antagonist (IL-1Ra), is used.
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IL-1Ra neutralizes the effect of IL 1, and has anti-inflammatory, analgesic and cartilageprotective effects. In the Orthokine method, various anti-flammatory proteins and growth
factors such as IL-1Ra are obtained from the patient's own blood and injected back into
the affected joint.
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The injection is equivalent to a type of routine orthopedic treatment, which is usually
tolerated by the immune system very well. Joint pain usually resolves quite quickly after
treatment, and this leads to the improvement of joint function.
IL-1 and IL-1Ra
 IL-1 Damages Cartilage
Cells
 IL-1Ra protects cartilage
cells against the aggressive
IL-1
 Anti-inflammatory
 Analgesic agent
 Cartilage protector.
Criteria
 Inclusion Criteria
 At least 18 years old
 Up to grade 1 knee
 Exclusion Criteria
 Poor general health
 Overweight, Diabetic,
osteoarthritis.
 Grade 1: Small osteophytes (a
type of bone spur) and joint space
narrowing may be present.
 Up to grade 2 knee
chondral lesion
(Outerbridge
classification).
 Classified from mild, moderate to
severe
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Serious Heart or Lung
Conditions, etc.
Infections
Osteomyelitis (inflammation
of bone marrow)
Alcohol/drug abuse
Corticosteroid or anticoagulant usage, and morbid
obesity.
Orthokine Pros/Cons
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Pros
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Non-Surgical or Narcotic treatment
 Low risk for infection or dependence
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Interleuikin-1-Receptor-Antagonist, which acts as an anti-inflammatory and analgesic agent.
 Protects cartilage
 Eases Pain
 Improves Mobility
 Prevents Degenerative Joint Disease
 Prevents Inflammation
 Bears a relatively long lasting effect
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Cons
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Multiple Injections
 6 over a five day period
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Not truly “proven,” but many high profile athletes swear by it.
 Placebo
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Current treatment lasts about 2 years
 Multiple treatments necessary for chronic sufferers.
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Requires an incubation period
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Side Effects Include:
 Temporary Pain, Swelling, Stiffness & Bruising.
High Profile Patients
FDA Approval
 Not FDA approved
 Most treatments are done in Europe and are paid for out of pocket
($7500)
 Germany, Austria, Slovakia, Czech Republic, Romania, Poland, Russia,
Slovenia, Bulgaria, Hungary, Israel, Italy, Croatia, Serbia, Montenegro,
Bosnia-Herzegovina, Kosovo, Macedonia, Spain, Portugal, Cyprus,
Australia, New Zealand, Taiwan, Lithuania, Finland, Latvia, Estonia,
Switzerland, Turkey
 Dr. Peter Wehling of Dusseldorf (Germany)
 Offices in New York and Los Angeles can practice but not
advertise
 2009 Study showed significant improvement over 7, 13, 26 and
104 weeks when compared to saline (placebo) and HA
(hyaluronan).
 Baltzer, A.W.A., C. Moser, S.A. Jansen, and R. Krauspe. "Autologous Conditioned Serum
(Orthokine) Is an Effective Treatment for Knee Osteoarthritis." Osteoarthritis and Cartilage
17.2 (2009): 152-60. Print.
Outlook
 Studies Show…
 Researchers compared the effects of injections of Orthokine,
hyaluronic acid and placebo in 310 arthritis patients over a
two-year period. Hyaluronic acid, a joint lubricant, is widely
used to treat arthritis. Saline was used as the placebo.
 "The two-year results confirm our previous studies: Orthokine
therapy provides long-term relief from pain and joint dysfunction
in many patients and does so more effectively than comparable
treatments”
 Two years after the series of injections, patients treated with
Orthokine scored substantially better than those treated with
hyaluronic acid or placebo on measures of pain and joint
function.
Bibliography
 http://clinicaltrials.gov/ct2/show/NCT01037738?term=orthokine&rank=1
 http://www.orthokine.com
 http://www.medicalnewstoday.com/releases/117165.php
 http://www.regenexx.com/wp-content/uploads/2012/07/orthokineregenokine.jpg
 http://www.orthohealing.com/2012/07/13/germany-regenokine-blood-spinningbiologic-orthopedic-treatments-in-ny-times/
 http://www.nytimes.com/2012/07/11/sports/athletes-with-chronic-pain-turn-tonovel-blood-treatment.html?pagewanted=all&_r=0
 http://www.regenexx.com/2011/12/irapture-interleukin-receptor-antagonisttherapy-a-k-a-regenokine/