STEM CELLS – A MIRACLE CURE?

Many people have probably read or viewed the recent publicity surrounding a couple of brilliant results involving the use of stem cell therapy on people suffering debilitating osteo-arthritic complaints. One in particular, involving the successful regrowing of cartilage in a 30 year old former National level karate champion can be seen here: http://www.melbournestemcellcentre.com/news/ but there was also another recent front page Herald Sun article on a young surfer whose knee arthritis had been “cured” with stem cell therapy.

There seems to be a never ending flow of “miracle cures”, new supplements, and revolutionary devices that appear on the market promising wonderful cures for debilitating conditions. As we remind our patients constantly, a lot of the promotion is just excellent marketing more than excellent research and evidence, and we constantly come back to the “n = 1” theory (the fact you are seeing the amazing results of one person only – who knows how many other cases of no success there has been to get that one amazing result)!

In the case of stem cell therapy, no doubt it is one of the most exciting developments in medicine we have seen. The theory is sound, the research is rapidly gaining strength and validity, and early trials are showing some life changing benefits for some arthritis sufferers! In this blog, we will look at the use of stem cells in the specific treatment of arthritis, but there are also other conditions that are predicted to benefit from the use of stem cells.

So let’s delve a bit more into stem cell therapy, and outline exactly where the therapy is at, and what we can all expect in the future.

Osteoarthritis

OA is fourth on the list of causes of disability across the world and there is evidence of OA changes on X-rays in up to 80% of people over 65 years of age, (but this doesn’t actually mean that all these people suffer pain from their arthritis – you can show radiological signs of moderate to advanced arthritis and still have no pain). With an ageing population and increased life expectancy, it is predicted OA issues will continue to increase in our population.

We have solid research and evidence supporting the benefits of exercise to manage and slow the progression of OA, and even help avoid the need for a joint replacement, however there will always be people who don’t respond to conservative therapy (or don’t try it) and many who, for various other reasons, end up with advanced arthritic changes in their lower limb joints. At this stage, the treatment of choice for end stage, debilitating OA is joint replacement surgery. Whilst generally a very successful surgical intervention (albeit with large potential risks) it is quite alarming that over 600,000 total knee replacements  are performed annually in the US and even more alarmingly it is predicted that the number of knee replacement revisions (eg those that need the primary replacement replaced again) will rise by 600% between 2005 and 2030.

Stem cell therapy is targeted at those that have advanced, painful arthritic joints, poor quality of life, and looking at the potential of joint replacement surgery to return their quality of life.

What are stem cells?

The actual terminology used is Mesenchymal Stem Cells (MSC). MSC are adult stem cells found mainly in bone marrow, umbilical cord, and fatty tissue. The critical importance of MSC is that they are undifferentiated (meaning they haven’t actually formed a particular cell type/role yet), and are multi-potent (meaning they have the ability to differentiate into a multitude of different cell types eg muscle/bone/cartilage cells).

It is thought that the purpose of MSC in the body is to assist repair and regeneration of damaged tissue, but that they also have a role in helping control our immune system and inflammatory responses. Being able to control an immune and inflammatory response as well as stimulate repair of damaged tissue gives great hope for MSC to not only modify the disease process of OA, but these properties also open a world of possibility with auto-immune conditions and other inflammatory arthritis conditions. Whilst MSC in our body seem to have the natural ability to migrate to sites of injury and damage, the ability to inject stem cells directly into the damaged area provides the opportunity to flush the joint with many millions of these restorative cells and create a greater healing response.

It is not yet clear where the best source of adult stem cells is. Bone marrow is the traditionally used method, but doesn’t produce anywhere near as many MSC as does human adipose (fat) tissue does, and it’s easier to harvest the stem cells via some liposuction than it is from within the bone marrow. Cells around the human umbilical cord are also a rich source of MSC.

Stem cells help regenerate, not replace, joints

The exciting thing with stem cells is it appears to be a regenerative technique. It is not a replacement of a joint, nor is it an agent to help simply reduce pain and inflammation (like cortisone, painkillers, synvisc, blood injections, and the multitude of supplements at the chemist that supposedly treat arthritis). The purpose of stem cells is to help repair and regenerate cartilage and therefore preserve the actual joint itself.

Over time, other regenerative techniques have been tried extensively and some of these include:

• Autologous Chondrocyte Transplantation: a technique where cartilage cells are harvested from a non weight bearing surface of the persons joint, grown in a laboratory, and then transplanted back into a localised area of damage. Some of the issues of this technique have been cost and time (multiple surgeries needed), up to 6 weeks non weight bearing after the procedure, pain around the donor (harvest) area, poor assimilation with the surrounding tissue, and a tendency to form a different type of cartilage than the articular cartilage normally situated in the joint.
• Micro-fracture: still being performed today, micro- fracture involves drilling or picking holes in the damaged area of bone underlying the cartilage damage, in the hope that the resultant bleeding and inflammation stimulates the migration of bone marrow cells to the area to promote healing. The problem with this technique can the pain it generally causes in the short term, it can only be performed on a localised lesion, and as with chondrocyte transplantation, there is a tendency for a different type of cartilage to be formed that doesn’t have the properties of normal joint cartilage. Long term results are also not overly encouraging.

As well as not having the risk factors of the above procedures, one of the real beauties of stem cell therapy is it can be used to treat a large surface of a joint, or even the whole joint itself, whereas the above two techniques are limited to small, localised lesions only.

The Studies

There are currently hundreds of stem cell trials being conducted, and the early findings appear to show:

• Significant pain and function improvement
• Potential prevention of the need for joint replacement surgery (one study of 339 patients requiring a total knee replacement, showed that only 63 of those people actually required knee replacement surgery after MSC therapy and another study showing only 2 out of 18 patients needing joint replacements following MSC therapy
• Cartilage repair and regeneration with similar resulting properties to normal joint cartilage
• Increased cartilage growth & thickness in treated joints
• No association with adverse effects such as infection, death, or malignancy

Where to from here?

As mentioned above, there are hundreds of really exciting clinical trials in progress and results are genuinely encouraging for the medical industry and all OA sufferers. Melbourne Stem Cell Centre is at the forefront of stem cell therapy and is an industry leader in the area of stem cell research for the treatment of arthritis and other joint disorders (http://www.melbournestemcellcentre.com/ )

A big thank you to Michael Kenihan, General Manager/Director of MSCC, for providing the following information on where stem cell therapy realistically is for all of us at this point in time:

• Stem cell therapy is a realistic option for those too young for joint replacement surgery, or those with traumatic (often sporting) cartilage defects that have failed other types of surgical therapy
• Young people who have damaged a meniscus and had subsequent surgery to remove the torn fragment of the meniscus. We know that losing components of the meniscus, especially when young, leads to early OA (hence why there is some hesitation to operate and “clean out” joints as habitually as occurred in years past). If these people start to show signs of wear of the articular cartilage, early intervention with stem cells may provide good outcomes in the prevention of later OA changes.
• Early to mid stage OA conditions do well, especially in the 45 to 60 yo age group. End stage OA (commonly referred to as “bone on bone”) in those older than 70 are not showing as good a result, but some are still having good results.
• Unfortunately at this stage the realistic cost is around $8,000 to $10,000 out of pocket. No rebates apply as yet.
• Those prepared to pay $220 (and potentially the greater cost of the procedure) can be assessed to see if stem cells will be useful or not. Julien Freitag is a leader in the provision of stem cell therapy in Melbourne – for anyone interested in contact details just email anthony@sspc.com.au.

• Efficacy (intended outcomes) is not certain in all cases. However healthier subjects do better as do those prepared to lose weight and get other forms of therapy (eg exercises) to complement the stem cell procedure . MSCC trials are showing great results with up to 75% of people showing improvements.
• In terms of safety, stem cell therapy is considered a low risk treatment. Mild swelling and fever after treatment seems to be the main side effect. There are some contraindications (people who cannot be considered) including: no evidence of cancer, not currently being pregnant, presence of hepatitis a,b, c.
• Cost will reduce when allogeneic methods (harvesting cells from a donor) is available. Currently only autologous methods (harvesting cells from the actual patient) are used. Allogenic methods may be available within 3-5 years and should bring the cost down to hopefully the $2,000 mark for treatment – much more palatable!
• MSCC statistics currently show treatments being performed on approximately 60% of knees, 15% hips and the rest ankle, shoulder, thumb, small fingers joints. The outcomes for all have been good.  Knee joints are the easiest to treat with it being possible to get a high number of cells (eg 50 million) into the joint. Knee joint OA is the most common condition treated.

So hopefully that brings you all up to date on what stem cell therapy is, how it is performed, and where it realistically sits in the management of OA right now. Some may be interested immediately, but the next 5 years is going to be enormous for stem cell therapy and hopefully we’ll find it becoming a more readily available procedure, with better techniques, improved predictability, great outcomes, and lower costs!

Anthony Lance

SSPC Physiotherapist

References available on request.