PRP enhances healing after Achilles Tendon Rupture

PRP being added to an Achilles Tendon Repair

If you rupture your Achilles tendon, new data suggests platelet rich plasma can enhance the healing.  In an abstract published by the journal Lancet, researchers from England discussed how they treated patients who had ruptured their Achilles with either PRP or a placebo.  Six weeks later, they biopsied the healing tendons under ultrasonic guidance.  In the study, they found improved cell content, better tendon fiber structure and more normal collagen (type 1) in the tendons treated with PRP.  The study included 20 patients (10 PRP, 10 Control) and is the first investigation in humans showing the significant value of using PRP to help treat Achilles tendon ruptures.  Of course, more data will be needed to confirm these important findings.  For years, I have been adding PRP to my achilles tendon repairs and if I ever rupture my own, I will certainly request that PRP is included in the treatment protocol.

AM 

Total Tendon

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

Kobe returns to Germany for another Knee Arthritis Treatment

KobeTeam.com

Kobe Bryant returned to Germany this past week to be treated with a blood derived treatment (Orthokine) again for his knee.  He has had this treatment in the past at least twice before.  It involves drawing blood and incubating it over a 24 hour period and then reinjecting a component of blood that has anti-inflammatory properties.  It is similar but not exactly the same as platelet-rich plasma therapy.  It would be most interesting to learn about how this has helped him over the years and in what specific ways. He clearly has thousands of miles of basketball on his knees and is also recovering from multiple other injuries.  We do not, however, have any data about the status of his knee cartilage or joint before or after any of these treatments.  Here is a detailed description of the "Orthokine" treatment.  

Kobe has with his travel and his wallet voted in favor of this treatment.  It will be quite interesting to see how he plays this year in the NBA.   It will also be instructive to follow Kobe's future medical interventions as a way of measuring the value of the one he just had in Germany.

AM

TotalTendon

Platelet Rich Plasma Significantly Improves Outcomes for Tennis Elbow in a 230 Patient Study

The American Journal of Sports Medicine (AJSM) has just published the largest study evaluating platelet-rich plasma.  The 230 patient study was conducted over the course of more than five years and represents the work of dozens of clinicians and researchers.  Overall, it is clear from the data that the use of PRP to treat chronic tennis elbow results in significant reductions in pain and elbow tenderness compared to an active control of needling of the elbow without PRP.  It is also safe and cost effective compared to cortisone and surgery.  This type of study is time consuming and expensive but will help guide patient and physicians decisions about how to best treat chronic tennis elbow.

Here is a lay press article on the article from Healio.

Read the full AJSM Abstract below.

AM
Total Tendon


Platelet-Rich Plasma Significantly Improves Clinical Outcomes in Patients With Chronic Tennis Elbow
A Double-Blind, Prospective, Multicenter, Controlled Trial of 230 Patients

1. Allan K. Mishra, MD*,†, 
2. Nebojsa V. Skrepnik, MD, PhD‡,
3. Scott G. Edwards, MD§, 
4. Grant L. Jones, MD‖, 
5. Steven Sampson, DO¶,
6. Doug A. Vermillion, MD#, 
7. Matthew L. Ramsey, MD**, 
8. David C. Karli, MD, MBA†† and 
9. Arthur C. Rettig, MD‡‡

1. ^†Department of Orthopedic Surgery, Menlo Medical Clinic, Stanford University Medical Center, Menlo Park, California
2. ^‡Tucson Orthopaedic Institute, Tucson, Arizona
3. ^§Division of Hand and Elbow Surgery, Georgetown University Hospital, Washington, District of Columbia
4. ^‖Department of Orthopaedic Surgery, The Ohio State University, Columbus, Ohio
5. ^¶The Orthohealing Center and The Orthobiologic Institute, Los Angeles, California
6. ^#Orthopaedic Research Clinic, Anchorage, Alaska
7. ^**Department of Orthopaedic Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania
8. ^††The Steadman Clinic, Vail, Colorado
9. ^‡‡Methodist Sports Medicine, Indianapolis, Indiana
10. Investigation performed at Department of Orthopaedic Surgery, Menlo Medical Clinic, Stanford University Medical Center, Menlo Park, California

1. *Allan K. Mishra, MD, Department of Orthopedic Surgery, Menlo Medical Clinic, Stanford University Medical Center, 1300 Crane Street, Menlo Park, CA 94025 (e-mail: am@totaltendon.com).

Abstract

Background: Elbow tenderness and pain with resisted wrist extension are common manifestations of lateral epicondylar tendinopathy, also known as tennis elbow. Previous studies have suggested platelet-rich plasma (PRP) to be a safe and effective therapy for tennis elbow.

Purpose: To evaluate the clinical value of tendon needling with PRP in patients with chronic tennis elbow compared with an active control group.

Study Design: Randomized controlled trial; Level of evidence, 1.

Methods: A total of 230 patients with chronic lateral epicondylar tendinopathy were treated at 12 centers over 5 years. All patients had at least 3 months of symptoms and had failed conventional therapy. There were no differences in patients randomized to receive PRP (n = 116) or active controls (n = 114). The PRP was prepared from venous whole blood at the point of care and contained both concentrated platelets and leukocytes. After receiving a local anesthetic, all patients had their extensor tendons needled with or without PRP. Patients and investigators remained blinded to the treatment group throughout the study.

Results: Patient outcomes were followed for up to 24 weeks. At 12 weeks (n = 192), the PRP-treated patients reported an improvement of 55.1% in their pain scores compared with 47.4% in the active control group (P = .094). At 24 weeks (n = 119), the PRP-treated patients reported an improvement of 71.5% in their pain scores compared with 56.1% in the control group (P = .027). The percentage of patients reporting significant elbow tenderness at 12 weeks was 37.4% in the PRP group versus 48.4% in the control group (P = .036). At 24 weeks, 29.1% of the PRP-treated patients reported significant elbow tenderness versus 54.0% in the control group (P < .001). Success rates for patients with 24 weeks of follow-up were 83.9% in the PRP group compared with 68.3% in the control group (P= .012). No significant complications occurred in either group.

Conclusion: Treatment of chronic tennis elbow with leukocyte-enriched PRP is safe and results in clinically meaningful improvements compared with an active control group.

The Biomet Biologics GPS device was used to prepare the PRP for this study.