Friday, December 12, 2014

Using a 3D Printer to Make a Knee Meniscus


Meniscus cartilage is the cushioning tissue between the femur and tibia bones of the knee.  Millions of Americans each year tear this cartilage.  Loss of the meniscus tissue can lead to arthritis.

In this novel approach, researchers in New York are using a 3D Printer to create a new meniscus.  They have studied in sheep so far with success.  In the future, it may be possible to use an MRI scan with a meniscus tear to help program a 3D printer to make you a new meniscus.  Treatment in human patients is not yet available but this is quite an intriguing possibility for the future.



Reference
TISSUE ENGINEERING

Protein-releasing polymeric scaffolds induce fibrochondrocytic differentiation of endogenous cells for knee meniscus regeneration in sheep


Read More

Read the scientific abstract

AM
TotalTendon

Tuesday, December 09, 2014

Microfracture Surgery Jadaveon Clowney

The Houston Texans' Jadeveon Clowney recently underwent "microfracture" surgery on his ailing right knee.  (See ESPN report)

The report suggests the talented Mr. Clowney will be out for 9 months or more.  Just what is microfracture surgery and why does it take as long to recovery as it does for a baby to born?

Microfracture Surgery
Let's start with the basics.  There are two types of cartilage in the knee.  The surface cartilage which covers the bone.  This is known as articular cartilage and can be thought of a type of cap or covering of the end of the bone.  This cartilage is present in any joint.  In the knee, there is another type of cartilage, the meniscus cartilage.  There are two menisci in the knee--medial (inside) and lateral (outside).  When the surface "articular" cartilage is damaged, the knee can become quite painful especially with loading and twisting.  Think rushing a passer for example.  Similar symptoms can occur when the meniscus is torn.  It is often difficult to distinguish between the two in terms of which one is the pain generator.

Microfracture surgery is an attempt to create a tire patch over a cartilage defect by poking a hole in the end of the bone and creating an access channel to the bone marrow.  The bone marrow then leaks out via the holes that are created and forms a clot which over time can help cover the defect.  It takes time, many months, for this surgery to work because the "patch" needs to mature.  This technique is useful for small defects in the cartilage but hasn't proven to be great for larger defects.  We do not know the size of Mr. Clowney's knee cartilage injury.

Recent evidence suggests that the addition of platelet-rich plasma can enhance microfracture surgery results.  This has been shown in basic science, preclinical and now clinical studies.

This type of surgery at such a young age is clearly not a good sign.  In the long run, he may require further intervention.  Please read the post below for further information about why we need to accelerate our regenerative medicine efforts.  Mr. Clowney is one of tens of millions of people worldwide with symptomatic cartilage damage.  We need to maximize outcomes of today's surgical techniques and develop new procedures to help keep our athletes and patients in the game.

AM

TotalTendon


Sunday, December 07, 2014

Will Kobe Bryant go to Japan to Treat his Knee Arthritis?

Japan Accelerates Regenerative Medicine with Regulatory Reforms

Why the United States Must Follow Their Lead


Kobe Bryant, an elite professional athlete from the National Basketball Association’s Los Angeles Lakers, has gone to Germany multiple times to be treated with a portion of his own blood for his creaky, arthritic knees.  The reason why he went to Germany is simple.  He wanted to have the best chance to play at the highest level in the NBA and he had exhausted all his options in the United States.  He went there to be treated with a component of his own blood that targets the inflammation associated with knee osteoarthritis.  The treatment he received is not approved here in the United States. 

Will he go to Japan next time to get the most advanced therapy?  That may happen because in November 2014 Japan enacted legislation creating a new pathway that accelerates the approval process for regenerative medicine products.  We here in the United States need to figure out how to best accelerate our own regenerative medicine efforts or continue to watch our elite athletes and other patients seek treatment beyond our shores.  Let’s explore why Japan acted boldly in favor of regenerative medicine. 

A Nobel Prize was awarded to Japanese researcher and former orthopedic surgeon, Dr. Shinya Yamanaka in 2012 for his pioneering work on how to reprogram mature skin cells into pluripotent stem cells.  His potentially life saving work and the national pride associated with it helped Japan become a worldwide leader in stem cell research.  Importantly, Japan has also prospectively pursued and passed legislation that will dramatically stimulate regenerative medicine.  The country took a leap into a bright future last week with the implementation of regulatory reforms directed at accelerating the development of cell-based treatments. 

The new law established a separate pathway for regenerative medicine products apart from traditional drugs and medical devices. The regulations also created a system that fosters faster commercialization of novel biologic products and can lead to time limited approvals for up to seven years.   Post market data analysis will continue to confirm the safety and efficacy of the regenerative medicine products with the potential to revoke approvals. 

The action by the Japanese government creates the proper equilibrium between the need for accelerated approvals for cell based therapies that have established efficacy while ensuring product safety.  The typical phase one, phase two and phase three trials for new drugs are not a proper pathway for cell-based therapies that have highly complex mechanisms of action that may or may not be identified even with elite preclinical models.  Importantly, many cell-based products come directly from a patient’s own body and therefore have a dramatically higher safety profile. 

Americans are screaming for new treatments for a variety of difficult problems such as arthritis, heart disease and diabetes.  Regenerative medicine and especially cell-based treatments have a chance to help treat and potentially cure these problems.  We need to follow the Japanese lead and create similar pathways in the United States.  Last year during a visit to Japan and its PMDA (the equivalent of the FDA), I was staggered by how engaged they were about regenerative medicine and receptive they were to understanding how to bring safe and effective biologic products to their populace.

The United States can learn a great deal from Japan’s enlightened approach to regenerative medicine.  Safety of course should be paramount.  The idea of a conditional, time-limited approval with reimbursement strikes a perfect chord as we seek better treatments for our patients at more affordable prices.  Competition will arise to obtain approvals based on phase two trials that confirm safety and show a solid degree of efficacy.  Importantly, more competition will lead to better options and faster innovation similar to the computer industry over the last several decades. 

We need to also emulate our Silicon Valley technology colleagues and call for a Medical Moore’s Law.  Identify a specific clinical problem, create a novel solution and within five years double the efficacy and decrease the price by fifty percent.  Data analysis via powerful graphical algorithms should assist with new discoveries and also help with better management of many diseases.  

We must seek dramatically higher horizons instead of being satisfied with iterative improvements.  The Japanese government should be congratulated for passing regulatory reform and implementing transformative solutions.  Sooner, not later, we need to find ways to execute our own regulatory reforms here in the United States to help our patients and to remain competitive on the world stage in regenerative medicine.

Perhaps, then Kobe will be treated in California instead of Germany or Japan.


TotalTendon


Sign the online petition supporting Regenerative Medicine



Please post any comments or suggestions about how to safely accelerate regenerative medicine.

References

Accessed 11/30/14


Accessed 11/30/14



Wednesday, November 12, 2014

Google Trends for Platelet Rich Plasma Rose 107% Last Week

The interest in Platelet Rich Plasma  (PRP) rose dramatically last week according to Google Trends.  This autologous biologic product and treatment continues to gain traction as a simple way to address challenging problems such as chronic tennis elbow.  As more clinicians, researchers and patients gain experience with it, better formulations and protocols will be developed to treat injuries and disorders safely and effectively.

We are now in the second decade of using PRP therapeutically and this trend is a signpost of worldwide interest.  This interest will also spark new innovations surrounding the use of blood therapeutically.

Patients and even payers will benefit from blood based breakthroughs because many newer biologic procedures will be as or more effective than surgery and less costly.

AM
Total Tendon

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Wednesday, October 29, 2014

Platelet Rich Plasma (PRP) Helps Patients

Platelet Rich Plasma (PRP) has been used now for more than a decade to treat a variety of orthopedic conditions.  Hundreds of thousands of patients have been treated with a stellar safety record.  The efficacy of PRP has evolved over the years but there are now multiple randomized controlled trials supporting the use of PRP.  This data has been presented at major medical conferences all over the world and published in peer reviewed elite journals such as the American Journal of Sports Medicine.

Below are the highlights from a few of the published papers:


Large Randomized Controlled Trial using PRP for Chronic Tennis Elbow Patients
American Journal of Sports Medicine 2014 

82.1% had successful treatment using PRP  compared to 60.3% in the active control group at six months.  (P = 0.008)  (See Figure)

There was also significantly less elbow tenderness in the PRP treated patients compared to the active control group at six months. (P = 0.009)

PRP Beats Cortisone for Chronic Tennis Elbow at 2 year Follow up
American Journal of Sports Medicine 2011 (100 patient trial)
Patients treated with PRP had dramatically better success rates at 2 years compared to cortisone.
(P < 0.001)

These two trials used the same protocol and same PRP device (Biomet GPS PRP).  There were no significant complications in either study.   Successfully treated patients were able to avoid more invasive and expensive surgical interventions.  This is clear evidence supporting the use of PRP for chronic tennis elbow.

PRP More Effective than Placebo in the Treatment of Knee Osteoarthritis
American Journal of Sports Medicine 2013 (156 knees)
50% improvement in pain scores was noted using PRP compared to worsening of pain in the placebo group at 6 months.  (P < 0.001)

There are now over 7400 references to PRP on PubMed with more than 500 publications last year alone.  This is an indication of the worldwide interest in this topic.   There are literally hundreds of published papers supporting the use of PRP and other blood components to treat disease.  More research and development will always be needed but using a patient's own blood to treat their injuries and disorders simply makes intuitive and scientific sense.  

Patients and providers with experience with platelet rich plasma or other biologic treatments are encouraged to post comments below.

AM
TotalTendon

Tuesday, October 21, 2014

Tennis Elbow Stretches

Tennis elbow is a very common problem.  Most often it can be treated with rest, activity modification and some simple exercises.

Check out the TotalTendon Tennis Elbow Stretching Protocol.



In future posts, I will demonstrate a strengthening protocol and discuss other treatment options.

AM
TotalTendon

Sunday, October 12, 2014

Proposition 46 Jeopardizes California Medical Excellence

California offers its citizens excellent health care.  It has over 100,000 hard working physicians dedicated to taking superior care of their patients in conjunction with well-trained nurses, medical assistants, technicians and support personnel. (Ref)  According to US News and World Report, 17 of California's hospitals are nationally ranked in specialities such as oncology, cardiology and orthopedic surgery.  Fifty-six other hospitals meet standards for strong performance within the state. (Ref

Proposition 46 is a direct threat to our superior California healthcare.   It would undermine a physician’s ability to best care for patients and result in dramatically higher costs—$9.9 billion annually according to one study (Ref)   Doctors already concerned about malpractice would face increased pressure to practice defensive medicine.  If this measure passes it will also be difficult to recruit and retain specialists who are in high risk specialties including OB/GYN, trauma surgery and neurosurgery. 

Proposition 46 further creates a disincentive for physicians to implement novel solutions to challenging diseases.   Medical innovation is needed to attack arthritis, cancer, diabetes, and the emerging Ebola epidemic.  If Proposition 46 passes, physicians will be less inclined to pursue new transformative solutions for fear of being sued and medical innovation will stall.  Instead of California physicians and hospitals being recognized as worldwide leaders in medicine, we may no longer be able to offer patients cutting-edge care within our state.   

Unfortunately, many Californians are unaware of the significant issues that will arise if Proposition 46 passes.  Over the past several months, I have had discussions with dozens of people about 46 and have been surprised at how little they know about this onerous proposition.  Their lack of awareness is frustrating because the trial lawyers completely understand the implications of the proposition they drafted.  As we approach the upcoming election, I strongly urge California residents to read and analyze proposition 46.    Prop 46 Info

One concern imbedded in the proposition that should be addressed is the need to curtail multiple prescriptions from being written and filled by deceptive patients.  The solution to this problem is not to pass the three-headed monster known as Proposition 46.  The better answer is to improve tracking technologies such as CURES that eliminate duplicate prescriptions from being ordered or filled at a pharmacy and at the same time increase the criminal penalties for patients that fraudulently try to  
obtain multiple narcotic prescriptions.

If you wish for California to maintain its worldwide leadership in the delivery of outstanding medical care, I urge you to Vote NO on Proposition 46.


Friday, October 03, 2014

Survivor Blood to be used as an Ebola Treatment

The Ebola epidemic is spreading and there is no cure.  Treatment options even in the United States are limited because there are no approved drugs and even the supply of experimental ones have been exhausted.  (See Washington Post Article)

Is it possible that blood could cure Ebola?

That is exactly what the New York Times (read full article here) is reporting as a possible treatment.  The concept is actually pretty simple.  Patients who have been infected with Ebola and survive develop antibodies to the virus.  These virus destroying proteins live in the serum of the blood.  A transfusion of serum or perhaps even whole blood may be the best option as a stop gap measure to treat the expanding number of patients with the disease.  The World Health Organization even has a specific guidance document on the topic.  (WHO convalescent blood for Ebola)

In this space over many years, I have discussed how to use blood therapeutically for regenerative medicine.  Discussions about platelet-rich plasma, bone marrow concentrates and stem cells from peripheral blood have focus primarily on orthopedic injuries and disorders.  Blood as a treatment for Ebola will receive more attention in this blog.  Anyone with blood expertise of any kind should do whatever they can to help.  Please post comments or send me information about how blood is being used to treat Ebola:   @bloodcure on Twitter.

The potential restorative powers of blood are considerable and if it is possible to stop the epidemic or at least slow it down by using the serum of survivors as a treatment, we should do everything we can do execute on that strategy in addition to pursuing containment, supportive care, and experimental drugs.

AM
TotalTendon

Wednesday, October 01, 2014

Concussions and the Michigan Football Program

Was he briefly knocked out?

It is appalling what happened on the Michigan football field last weekend.  A young man, quarterback Shane Morris, already suffering from an ankle injury, gets absolutely rocked by a blitzing defender.  The video shows how Morris's head snaps back and he falls to the ground like a rag doll.
(Detroit Free Press Article with videos)

It is absurd to excuse anyone on the Michigan sidelines for not knowing that Shane Morris may have had a concussion on that play because a major roughing the passer penalty was called.  He was also clearly staggering.  I am a double Michigan alumni (BS, MD) and love the school and its athletics.  I have also been on the sidelines of many high school, collegiate and professional football games as one of the team physicians.  The reason the physicians are there is to watch the game and scan the players for any real or potential injuries during or after each play.  It is difficult to understand why a serious roughing the passer penalty was not a clear indication for Morris to be evaluated especially before reinserting him into the game.

It is equally amazing that Hoke did not know about the potential extent of the injury the day after the game.  He may be incompetent as a coach given Michigan's record over the last few years but he is clearly dangerous when it comes to executing his responsibilities to protect his players.

What is even more telling than the even the video are still shots from the video.  

Initial Hit

Head Snaps Back

Clearly he sustained some head trauma


At the very least, Michigan needs better injury procedures in place and a coach that isn't frankly dangerous to his players' short and long term health.







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