Welcome to a new year of trying to stay fit and healthy! At BSEMS we have already been busy working over the Christmas break in covering both the Brisbane Bullets NBL team, and providing the medical cover for the Brisbane International Tennis Tournament.
In 2018 we are happy to welcome back our list of hard working specialists who aim to cover each and every problem you might have that is stopping you from being active and happy. We are also pleased to welcome the addition of our new registrar, Dr Neil Stevenson. We will have an up to date bio up for Neil in the near future.
Advances in the science of Sport and Exercise Medicine continue in leaps and bounds. Our practitioners are expected by our various professional bodies to stay up to date to ensure we provide current, safe and exercise based treatments. Sometimes unfortunately marketing can rush ahead of evidence, with some less scrupulous practitioners making promises to vulnerable patients that don’t stack up.
The Australasian College of Sport and Exercise Physicians (ACSEP) has recently published updated position statements on the use of Stem Cell Treatment (see statement below). They urge common sense and caution, but concede that revision is needed as further studies and science evolve.
As always happy exercising!
Australasian College of Sports and Exercise Physicians Position Statement
The use of Autologous Mesenchymal Stem Cells in Sport and Exercise Medicine
Introduction
• This Australasian College of Sport and Exercise Physicians (ACSEP) Position Statement provides a 2017 update to the previously published ACSEP Position Statements. (1, 2)
• Where applicable, level 1-2 evidence1 has been utilised to formulate the current position statement.
1 For details on levels of evidence, readers are directed to references 23-25
2 For further details see: https://www.tga.gov.au/media-release/regulation-autologous-cell-and-tissue-products
Background
• The use of autologous mesenchymal stem cells with their identified capability of differentiating into various mesodermal and endodermal cell lines, has the theoretical potential and shows promise of being able to positively influence musculoskeletal tissue healing and regeneration.(3)
• The use of stem cells as a means of treatment are being investigated across a range of medical disciplines,(4) but stem cell research in the realm of musculoskeletal sports medicine is of varying quality.(5-7)
• The means of extraction, manipulation and application of mesenchymal stem cell therapy in musculoskeletal medicine remains an evolving, non-standardised practice.(8)
• The application of autologous mesenchymal stem cells (MSC) in the management of sports injuries and degenerative musculoskeletal conditions is an emerging approach to treatment that is being embraced by industry, patients and many practitioners.(3, 4, 9)
• Sports and Exercise Medicine, particularly as practiced with elite athletes, has a history of working at the “cutting edge” of musculoskeletal practice enabling the early adoption of new technology and techniques.(10-12)
• To date, the majority of research investigating the use of MSC for musculoskeletal conditions has contributed only low level evidence.(6, 7)
• The development and clinical application of mesenchymal stem cell therapies in Sports Medicine has a significant industry and commercial influence.(5, 13)
• The combination of commercial interest, limitations in regulatory oversight, complex pathology and high levels of consumer expectation, has created an environment where the unproven potential of MSC therapy is an enticement for both practitioners and patients.
• Regulation of stem cell therapy remains a complex, evolving area, with multiple invested parties.(14) The Therapeutic Goods_Administration (Australia’s regulatory authority for therapeutic goods) has recently completed a two year public consultation process and has committed to enhanced regulation of the use of Stem Cell therapies.2 Future regulatory clarity on the use of Stem Cells may result in the evolution of components of this position statement.
• The ACSEP Code of Ethics provides further details on the standards of practice for Sports Physicians with regard to industry influence, research standards and the application of evidence-based medicine in sports medicine.3
3 Readers are directed to the following link for details. http://www.acsep.org.au/content/Document/P015%20Code%20of%20Ethics%20%26%20Professional%20Behaviour.pdf
4 This position statement addresses only those conditions frequently managed by Sport and Exercise Physicians. Specifically, it has not considered research related to combined surgical procedures.
ACSEP Position on the Efficacy of Autologous Mesenchymal Stem Cell Therapy in Sport and Exercise Medicine
Osteoarthritis
• The most recent systematic review of Stem Cell therapy in knee osteoarthritis found only 5 randomised trials including 101 patients, assessing the role of MSC in osteoarthritis.(7)
• All included studies had a high risk of bias.(7)
• Level 4 –5 evidence was found for reduction in pain, patient reported outcomes, imaging outcomes, histological and arthroscopic outcomes.(7)
Tendinopathy
• The most recent systematic review of Stem Cell therapy in tendinopathy revealed only 4 published trials, totalling 79 patients.(6)
• All studies had a high risk of bias.(6)
• Level four evidence supports positive outcomes from stem cell therapy.(6)
Osteochondral Defects
• While methodologies have been published,(15) no randomised controlled trials or systematic reviews of the use of MSC to manage osteochondral defects were identified.
Other
• No additional randomised controlled trials or systematic reviews for the management of musculoskeletal conditions were identified.
ACSEP Position on the Safety of Autologous Mesenchymal Stem Cell Therapy in Sport and Exercise Medicine
• Formal assessment of safety must consider the wide variation in source, preparation and application of stem cells in therapeutic approach.
• Evidence for the safety of stem cell therapies remains inadequate with limited long term follow-up data.
• Both mild and severe adverse outcomes from the therapeutic use of stem cells have been reported in the non-musculoskeletal application of MSC.(16-21)
• The majority of reports indicate that at least in short term follow-up, the use of MSC in musculoskeletal sports medicine practice is relatively safe. There are currently no long term follow-up studies.(6, 7, 22)
ACSEP Position on the use of Mesenchymal Stem Cell therapies in Sport and Exercise Medicine
1. There is insufficient evidence to support the use of MSC therapy in the routine management of musculoskeletal injuries or degenerative conditions typically managed by Sport and Exercise Physicians.
2. The inclusion of innovative MSC therapies into routine clinical practice should only occur after clinical trials establish reproducible evidence of MSC efficacy and safety in musculoskeletal sports medicine.
3. The ACSEP endorses only stem cell research that contributes L1-3 evidence.(23-25)
4. The ACSEP recognises the importance of proactive regulatory oversight for the processing and manipulation of any medical product, including MSC.
5. While both safety and efficacy data are lacking, the ACSEP believes it is unethical and unprofessional to market stem cell interventions directly to patients.
6. This position statement does not preclude the ACSEP from future recognition of the role MSC may play in the management of musculoskeletal sport medicine should acceptable levels of efficacy and safety be established.
Date: November 1 2017
Reviewed and Endorsed by ACSEP Research Committee
Approved by ACSEP Board November 14, 2017
For review 2020, or under direction of ACSEP Board
Working Group
Dr. Bruce Hamilton (Chair) – FACSEP
Dr. Greg Lovell – FACSEP
Dr. Lynley Anderson – PhD
Dr. Jeni Saunders – FACSEP, has previously performed small number (4) bone marrow aspirate concentrated MSC procedures and ceased these when the initial Position Statement on Stem Cells was released.
Dr. Ruben Branson – FACSEP, Director at SportsMed Biologic, has previously provided mesenchymal / stromal vascular fraction (SVF) / stem cell therapy to patients with osteoarthritis in very small numbers with no income received from any stem cell company or related financial institution or entity, nor any shares or financial relationship with any stem cell provider.