Being an Immunology student, I was fairly skeptical of a
procedure that could be conducted with the simplest of laboratory instruments
and still be effective. Also, if it was so simple, why are patients going to
foreign countries instead of receiving treatment closer to home. After some
intense Googling, I found that this is actually a process based heavily on
immunological pathways. Apparently the serum that is separated from blood and
injected into the body is high in anti-inflammatory factors, such as TGF-B and
soluble IL-1RA. Thus, the presence of
these molecules could help alleviate the amount of inflammatory cells at an
arthritic joint. Also, TGF-B promotes tissue repair and angiogenesis,
suggesting that this procedure may not just stop the aberrant inflammation, but
also possibly reverse it. Unfortunately, the FDA has a very vague rule that
human tissues for therapy must be minimally manipulated. Actually, “the FDA defines minimal manipulation as “processing that does not alter
the relevant biological characteristics of cells or tissues.”” Thus, the
question becomes does centrifuging blood or incubating it overnight at a
slightly elevated temperature qualify as minimal manipulation, or something
more? Unfortunately, no doctors in the United States seem to know the answer
nor are willing to find out. So until then, rich athletes will keep flying to
foreign countries to receive treatment, while millions of other Americans with
joint pains are missing out on a potentially effective and inexpensive
treatment.
Wednesday, April 25, 2012
Regenokine
Recently my favorite sports and pop culture website,
Grantland.com, posted a piece on sports science so relevant that it was the UC
Health News Daily the next day. The article can be found here for anyone
interested: http://www.grantland.com/story/_/id/7796225/kobe-bryant-dr-chris-renna-regenokine-knee-treatment
. Essentially, there is a new medical treatment for arthritis and other joint
pains that is causing famous athletes, like Kobe Bryant and Alex Rodriguez, to
go overseas to prepare their bodies for upcoming sports seasons. The reason
they must go to countries like Germany, is that the procedure is currently
illegal in the USA due to an extremely vague FDA stance on the process.
However, this medical process, referred to as Regenokine, is actually quite
simple. It involves taking blood from the patient, incubating this blood at a
temperature slightly above 37˚C overnight and separating the serum
from the blood after. This serum is then injected to the area of inflammation,
such as Kobe’s knee. The results from this simple procedure seem to be quite effective;
Kobe is currently leading the NBA in scoring in his 16th season.
Although there is currently not a large enough sample size to prove just how
effective and how long lasting the procedure is.
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Nice post, Dan. Safety is a valid concern, but at least there appears to be a good rationale for the procedure. It is frustrating that we lack better treatments for inflammatory conditions such as arthritis, or the common complaint, lower back pain. I've experienced sometimes severe low back pain since I was 16. I found Celebrex was amazingly more effective than ibuprofen or similar anti-inflammatory meds. Unfortunately, I cannot get it very easily now. In what seems like an over-reaction to underpowered, correlative data (though I'm not claiming to be an expert on the subject), Vioxx, a similar COX-2 inhibitor was pulled, and the likelihood of Celebrex ever going over the counter is quite low. I'm glad to see other methods pursued, though for a non-professional athlete like myself, I do hope to see less extreme treatments developed than the serum injection...Thanks for the interesting post!
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ReplyDeleteCan't agree with any more. Dan, this is a nice post. Self-serum injection is a good news, not only for osteoarthritis patients but also for doctors, since growing numbers of patients are undergoing joints swollen and pain. Is this therapy works effectively for RA, SpA and JIA patients?
ReplyDeleteDan, I 'm really interested in this topic and have hundreds of questions for this faking-fever treatment. Probably you can clear these doubts. Why do they incubate blood overnight before injection? Faking-fever is for producing amounts of anti-inflammatory factor? In the incubation process, neutrophils and CD8 T cells and other cells would be go through death pathway and secrete some cytokines and other factors we don't know that right now. Do these cytokines contribute to the healing process? If TGF-b and IL-1RA play an important role in it, why not just inject them into knees instead of injecting steroid locally or taking NSAIDs?
I guess I need to do more digging work. Anyway, thank you for your sharing. I really like it.
Thanks for sharing a very innovative and interesting technique in simple, easy-to- understand terms.I liked the last few sentences where you ended the post by raising a valid and important question.
ReplyDeleteInteresting news and great thoughts! I would say that science usually run circle around policy. Taking about applying human tissue for therapy, it makes me think intravenous immunoglobulin (IVIG) therapy. The therapy is a blood product administered intravenously, which contains the pooled, polyvalent, immunoglobulin (antibody) G extracted from the plasma of over one thousand blood donors. (For more information: http://en.wikipedia.org/wiki/Intravenous_immunoglobulin) Since a complicated therapeutic method like this can pass through FDA’s examination, I believe the Regenokine therapy can also pass someday.
ReplyDeleteinteresting post Dan thank you, even if the FDA did not prove it yet, but its sounds promising cure or at least short term solution.it is very encouraging when the discoveries comes from simple ideas.
ReplyDeleteThis procedure is similar to the autologous blood transfusion with different storage conditions, it is very easy and affective treatment. But, I wondered why they incubate it as a whole blood because the red blood cells might Lyse under these conditions!
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ReplyDeleteI think this therapy sounds great, however the underlying mechanisms that are responsible for the long-lasting and dramatic effects of this therapy need to be worked out. The FDA is probably waiting for these mechanistic studies to be completed before approving regenokine. Similar therapies have also been suggested for tendon and muscle repair but I do not know enough about those studies to comment more on them. Unfortunately, I believe the FDA holds a double standard when you compare anti-inflammatory therapies to psychiatric therapies. Psychiatric therapies are often approved if a molecular mechanism is proposed and clinical trials demonstrate symptomatic relief, even when the specific pathways involved in the disease are unknown. Most of the components and pathways involved in inflammation are well-characterized. So why has Regenokine not been approved by the FDA? Is it because the specific components of Regenokine that induce tissue repair and healing have not been named and specific mechanisms published? Maybe, but I do believe we need brilliant researchers to tackle neuroscience and psychiatry in order to uncover the true pathways of psychiatric disease, which will allow for more targeted therapies and treatment without the significant side effects seen in psych patients today.
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