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

Sign the online petition supporting Regenerative Medicine

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.

Allan Mishra, MD

TotalTendon


Sign the online petition supporting Regenerative Medicine

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

References

(http://www.nobelprize.org/nobel_prizes/medicine/laureates/2012/yamanaka-facts.html)

Accessed 11/30/14

http://www.pmda.go.jp/english/events/2014taiwan_sympo/14_Keynote1.pdf

Accessed 11/30/14

Platelet Rich Plasma Helpful for Patellar Tendonitis in Athletes

A new study published in the American Journal of Sports Medicine that ultrasonic guided platelet rich plasma  (PRP) injections improved pain and function in athletes with chronic patellar tendinopathy.  (See abstract below)

Patellar tendinopathy typically affects running and jumping athletes such as tennis, volleyball and basketball players.  It manifests itself with pain in the front of the knee and typically is worse with repeated jumping activities.  Most often, it will resolve with appropriate non-invasive treatment such as rest, icing and physical therapy.  It can be difficult to treat.  When the symptoms persists, published data supports the use of PRP injections.

AM
TotalTendon

1. Christophe Charousset, MD*,†, 
2. Amine Zaoui, MD‡, 
3. Laurence Bellaiche, MD§ and 
4. Benjamin Bouyer, MD∥

+Author Affiliations

1. ^†Institut Osteo Articulaire Paris Courcelles, Paris, France
2. ^‡Laboratory of Bioengineering and Biomechanics for Bone Articulation, University of Paris, Paris, France
3. ^§Centre D’image Médicale Bachaumont, Paris, France
4. ^∥Biostatistics and Epidemiology Department, Hotel Dieu Hospital 1, Paris, France
5. Investigation performed at the Institut Ostéo Articulaire Paris Courcelles, Paris, France

1. ↵* Christophe Charousset, MD, Institut Osteo Articulaire Paris Courcelles–60 Rue de Courcelles, 75008 Paris, France (e-mail: dr.charousset@ioapc.fr).

Abstract

Background: Chronic patellar tendinopathy (PT) is one of the most common overuse knee disorders. Platelet-rich plasma (PRP) appears to be a reliable nonoperative therapy for chronic PT.

Purpose: To evaluate clinical and radiological outcomes of 3 consecutive ultrasound (US)–guided PRP injections for the treatment of chronic PT in athletes.

Study Design: Case series; Level of evidence, 4.

Methods: A total of 28 athletes (17 professional, 11 semiprofessional) with chronic PT refractory to nonoperative management were prospectively included for US-guided pure PRP injections into the site of the tendinopathy. The same treating physician at a single institution performed 3 consecutive injections 1 week apart, with the same PRP preparation used. All patients underwent clinical evaluation, including the Victorian Institute of Sport Assessment–Patella (VISA-P) score, visual analog scales (VAS) for pain, and Lysholm knee scale before surgery and after return to practice sports. Tendon healing was assessed with MRI at 1 and 3 months after the procedure.Results: The VISA-P, VAS, and Lysholm scores all significantly improved at the 2-year follow-up. The average preprocedure VISA-P, VAS, and Lysholm scores improved from 39 to 94 (P < .001), 7 to 0.8 (P < .0001), and 60 to 96 (P < .001), respectively, at the 2-year follow-up. Twenty-one of the 28 athletes returned to their presymptom sporting level at 3 months (range, 2-6 months) after the procedure. Follow-up MRI assessment showed improved structural integrity of the tendon at 3 months after the procedure and complete return to normal structural integrity of the tendon in 16 patients (57%). Seven patients did not recover their presymptom sporting level (among them, 6 were considered treatment failures): 3 patients returned to sport at a lesser level, 1 patient changed his sport activity (for other reasons), and 3 needed surgical intervention.

Conclusion: In this study, application of 3 consecutive US-guided PRP injections significantly improved symptoms and function in athletes with chronic PT and allowed fast recovery to their presymptom sporting level. The PRP treatment permitted a return to a normal architecture of the tendon as assessed by MRI.

http://ajs.sagepub.com/content/42/4/906.abstract

Best Initial Knee Stretch "The Hammy" (Knee OA, Part 3)

Your hamstring tendons start on your pelvis and insert behind and below your knee. In almost every person, these tendons tighten with time.  Stretching your hamstring tendons is one of the best exercises you can do for your knee and back.  One study found "individuals with and without osteoarthritis of the knee are able to demonstrate immediate beneficial adaptations to a stretching intervention."
Reference

I recommend do a set of 3 hamstrings stretches, 3 times PER DAY.  Stretching multiple times per day is better than stretching only once a day or not at all.  You may be surprised with your improved flexibility if you are consistent about stretching.  See the video below for a simple stretch that can done anywhere.  I call it the "Hammy Stretch".



Start by placing your leg on a step, or low table.  Keep your back straight and your toes pointed toward the ceiling.  Then, simply hinge forward at your waist.  You will likely feel the stretch in the back of your thigh, knee and calf.

Consistency is the key to improvement.  Try this simple exercise and it will help your overall knee health and improve your ability to straightening your knee.  Hamstring stretching is like sunscreen, it is best to start early and continue to stretch throughout your life.

As always, check with your own doctor before beginning any exercise program.

Next time, we reveal the simple yet highly effective way to strengthen all of the muscle of your legs.

AM
TotalTendon

Kobe Bryant Tears Achilles Tendon

Kobe Bryant last night in made a cut on the basketball court he has made a million times and felt like "somebody kicked" him.  He unfortunately sustained an achilles tendon tear.   See the video below of the injury:



He will likely have surgery in the near future.  The surgical takes about an hour.  Rehabilitation typically takes anywhere from 9-12 months.  Some surgeons are augmenting achilles repairs with platelet-rich plasma pointing to anecdotal evidence suggesting PRP could accelerate recovery.

Here is a video of how to clinically diagnosis an achilles tendon tear:



Below are some pictures that outline the steps in an Achilles tendon repair  
Torn tendon, suture repair, closure

If anyone can come back from this injury, Kobe can.  The NBA and all of basketball are wishing him the the best for his surgery if needed and for his full recovery.

AM
TotalTendon

Platelet Rich Plasma better than Shock Wave for Jumpers' Knee

Jumpers' knee also known as patellar tendinitis is a common problem for basketball and volleyball players among other athletes.  Patients treated with platelet-rich plasma for this condition when compared to shock wave treatment improved more at six and 12 months after treatment.  See abstract below.

This paper adds to the mounting data suggesting PRP is a valuable treatment for chronic tendon related problems such as Jumpers' knee.

MRI of Patellar Tendinopathy

Also Known as Jumpers' Knee

AM

TotalTendon

Am J Sports Med. 2013 Feb 13. [Epub ahead of print]

Platelet-Rich Plasma Versus Focused Shock Waves in the Treatment of Jumper's Knee in Athletes.

Vetrano M, Castorina A, Vulpiani MC, Baldini R, Pavan A, Ferretti A.

Source

Physical Medicine and Rehabilitation Unit, Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.

Abstract

BACKGROUND:Tendinopathies represent a serious challenge for orthopaedic surgeons involved in treatment of athletes. PURPOSE:To compare the effectiveness and safety of platelet-rich plasma (PRP) injections and focused extracorporeal shock wave therapy (ESWT) in athletes with jumper's knee. STUDY DESIGN:Randomized controlled trial; Level of evidence, 1. METHODS:Forty-six consecutive athletes with jumper's knee were selected for this study and randomized into 2 treatment groups: 2 autologous PRP injections over 2 weeks under ultrasound guidance (PRP group; n = 23), and 3 sessions of focused extracorporeal shock wave therapy (2.400 impulses at 0.17-0.25 mJ/mm(2) per session) (ESWT group; n = 23). The outcome measures were Victorian Institute of Sports Assessment-Patella (VISA-P) questionnaire, pain visual analog scale (VAS), and modified Blazina scale. A reviewer who was blinded as to the group allocation of participants performed outcome assessments before treatment and at 2, 6, and 12 months after treatment. Nonparametric tests were used for within-group (Friedman/Wilcoxon test) and between-group (Kruskal-Wallis/Fisher test) testing, and the significance level was set at .05. RESULTS:The 2 groups were homogeneous in terms of age, sex, level of sports participation, and pretreatment clinical status. Patients in both groups showed statistically significant improvement of symptoms at all follow-up assessments. The VISA-P, VAS, and modified Blazina scale scores showed no significant differences between groups at 2-month follow-up (P = .635, .360, and .339, respectively). The PRP group showed significantly better improvement than the ESWT group in VISA-P, VAS scores at 6- and 12-month follow-up, and modified Blazina scale score at 12-month follow-up (P < .05 for all). CONCLUSION:Therapeutic injections of PRP lead to better midterm clinical results compared with focused ESWT in the treatment of jumper's knee in athletes.

Treatment of Patellar Tendinopathy with Platelet Rich Plasma

"Clinically Meaningful Improvements"

Statistically Significant Improvement (Pain and VISA Scores) 

Gosens et al, worldwide leaders in platelet rich plasma research have shown in their latest article how previous treatments influence outcomes.  This is a critical component to understanding outcomes.  This data suggests that previous treatment with cortisone or surgery may slow a healing response.  As the clinical research evolves, these crucial factors must be taken into consideration.  

See the recently published abstract below.

Allan Mishra @bloodcure  Total Tendon

Int Orthop. 2012 Apr 27. 

Pain and activity levels before and after platelet-rich plasma injection treatment of patellar tendinopathy: a prospective cohort study and the influence of previous treatments.

Gosens T, Den Oudsten BL, Fievez E, van 't Spijker P, Fievez A.

Source

Department of Orthopaedics and Traumatology, St Elisabeth Hospital Tilburg, Tilburg, The Netherlands, 

Abstract

PURPOSE:

The aim of this study was to evaluate the outcome of patients with patellar tendinopathy treated with platelet-rich plasma injections (PRP). Additionally, this study examined whether certain characteristics, such as activity level or previous treatment affected the results.

METHODS:

Patients (n = 36) were asked to fill in the Victorian Institute of Sports Assessment - Patellar questionnaire (VISA-P) and visual analogue scales (VAS), assessing pain in activities of daily life (ADL), during work and sports, before and after treatment with PRP. Of these patients, 14 had been treated before with cortisone, ethoxysclerol, and/or surgical treatment (group 1), while the remaining patients had not been treated before (group 2).

RESULTS:

Overall, group 1 and group 2 improved significantly on the VAS scales (p < .0.05). However, group 2 also improved on VISA-P (p = .0.003), while group 1 showed less healing potential (p = 0.060). Although the difference between group 1 and group 2 at follow-up was not considered clinically meaningful, over time both groups showed a clinically significant improvement.

CONCLUSION:

After PRP treatment, patients with patellar tendinopathy showed a statistically significant improvement. In addition, these improvements can also be considered clinically meaningful. However, patients who were not treated before with ethoxysclerol, cortisone, and/or surgical treatment showed the improvement.