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«Consideration of Discussion Paper on the Regulation of Autologous Stem Cell Therapies Dr Kevin A Boundy – Regenexx Australia [Type text] Table of ...»

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Consideration of Discussion

Paper on the Regulation of

Autologous Stem Cell

Therapies

Dr Kevin A Boundy – Regenexx Australia

[Type text]

Table of Contents

General Discussion

Introduction

Safety

Efficacy

Public Health Risks

Costs

Executive summary

Recommendations

Answers to Discussion Questions

What are the public health risks of ‘autologous stem cells’ in your view?

What is the evidence for these risks?

What identified risks should have the highest priority for resolving?

What do you see as the likely risks, benefits and costs of each option to you? If possible, please attempt to quantify these costs and benefits.

How do you think each option addresses the risks you identified in the earlier question?............... 13 Are there additional issues with the regulation of autologous stem cells that any changes should consider and/or address?

Discussion question for Option 1

Discussion question for Option 2

General Discussion Introduction This document is prepared by Kevin Boundy. I license a bone marrow derived stem cell procedure for the treatment of musculoskeletal problems from Regenexx in the United States. I will be confining most of my comments to the discussion of the use of bone marrow derived stem cells for musculoskeletal problems.

Consideration of Discussion Paper on the Regulation of Autologous Stem Cell Therapies Safety I believe that at present I am using bone marrow derived stem cells homologously.

All of the stem cells are autologous and only used to treat a single patient for a single indication in a single course of treatment. The stem cells are derived from bone marrow. Bone marrow has been used by orthopaedic surgeons when performing the Steadman Technique (microfracture) to repair damaged articular cartilage for some years.

I believe the use of bone marrow derived stem cells has been proven to be safe.

There are very few recorded incidences of side effects in the literature, and the American Cancer Society reports that hundreds of thousands of people have been treated with bone marrow transplants (by infusion) with no side effects.

Numerous safety studies have been published and a meta-analysis1 of the safety studies has been done showing that stem cells are indeed safe. The meta analysis was based on a review of papers examining the safety of cultured stem cells, which, according to the TGA’s discussion paper, are associated with higher risk then noncultured stem cells. The meta-analysis singled out Chris Centeno’s paper in particular as being robust and thorough in it's recording methods. Chris Centeno is the founder of Regenexx. I follow the Regenexx protocols for reporting adverse effects to the parent company. Any adverse events are then followed up with further investigation.

Efficacy

The efficacy of bone marrow derived stem cells in a culture-expanded form has been shown in a systemic review2. Although no placebo controlled trials of significance have been performed, this is the same with most surgical procedures. The metaanalysis of experimental groups leaves no doubt that, in appropriate numbers, stem cells can lead to an improvement in cartilage cover in an arthritic or otherwise damaged joint.

Apart from the benefits of improving cartilage cover with high doses of stem cells 3, Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review Peeters, C.M.M. et al.

Osteoarthritis and Cartilage, Volume 21, Issue 10, 1465 - 1473 Stem cell therapy for human cartilage defects: a systematic review Pastides, P. et al.

Osteoarthritis and Cartilage, Volume 21, Issue 5, 646 - 654 Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial.

Consideration of Discussion Paper on the Regulation of Autologous Stem Cell Therapies even in lower doses there are strong anti-inflammatory (immuno-modulatory) effects that reduce the number and type of chemicals that lead to cartilage damage and formation of osteophytes.

Much has been made of the bi-modal immunological effects of stem cells in the discussion paper from the TGA, as if it were a potentially dangerous and unwanted side effect. When I asked for a reference list so I could review these articles the TGA would not release it. The refusal of the TGA to release the original articles on which their statements were based has made it impossible for me to talk to this point in more detail. It would appear, however, that this and many of the other side effects mentioned in the discussion paper are not related to the musculoskeletal use of stem cells.

Public Health Risks Public health risks fall into three broad categories.

Firstly, there is a risk to the individual that they are receiving a product that may be dangerous to them. This has been discussed above under safety. The two main risks to the individual patient are that the tissue samples are not handled in accordance with TGA guidelines on GMP, or that the procedure will not make any difference to their condition.

Regenexx insists that all of its licensees follow standard operating procedures that meet or exceed the standards outlined in the TGA’s guide to GMP. Only one patient’s tissues are processed at any one time, and strict sterile techniques are followed. Bone marrow is harvested in an operating theatre and processed in a biological safety cabinet. All transportation between the OT and the laboratory is performed in sterile bags that are clearly labeled with the patient’s identification.





Experience with thousands of patients in America means that all patients who express an interest in a Regenexx stem cell procedure can be given an indication of the likelihood of success on a rating of good through fair to poor. My own experience means that patients who demonstrate certain characteristics such as loss of joint ROM or significant osteophytic disease on x-ray or MRI are advised they are not suitable candidates for the procedure. Having specialist training in Sports and Exercise Medicine I am able to give all patients a range of treatment options if they are not yet or no longer candidates for a stem cell procedure.

Understanding who will and who will not benefit from the treatment helps keep the public health risk of performing an ineffective treatment to a minimum.

Jo, C.H. et al.

Stem Cells. 2014 May; 32(5): 1254-66 Consideration of Discussion Paper on the Regulation of Autologous Stem Cell Therapies Secondly, there are risks to the community if treatments provided lead to an increased risk in the community of further disease.

Stem cell therapy only requires a day stay in hospital. This reduces the patient’s exposure to hospital-acquired pathogens. It also frees up beds that might have been occupied by patients having major procedures such as knee replacements.

The regenerative nature of the treatment compared to arthroscopic chondroplasty or meniscectomy means that there is less likelihood the patient will be readmitted for further surgery in the near future.

Thirdly there are the health risks from associated disease states, or co-morbidities.

Being sedentary, or un-fit, is a major contributor to death of Americans today4.

Severe degenerative joint disease is often associated with an increasingly sedentary lifestyle and hence the development or worsening of cardiovascular disease, hypertension, and type II diabetes. Keeping people on a public hospital waiting list until a hospital can accommodate the theatre time and bed space for major surgery puts the patient at risk of worsening of these co-morbidities.

Costs Lastly, much has been made of the “high cost” of these procedures. This is a classic case of detractors seizing on a snippet of information to malign something with which they do not agree.

Although patients are quoted about $9000 for a stem cell procedure this quote includes the total cost of the procedure, the hospital stay, the anaesthetist’s fees, and aftercare.

The private hospital where I work charges $1400 for the use of the operating theatre (and $700 for the day stay bed) for the bone marrow draw. This is rated as a “band 4” procedure. Patients are charged less if they have an arthroscopy. This seems odd considering a bone marrow draw only requires a trocar, some heparin, and some 30cc syringes. An arthroscopy can require trays of sterilized equipment, cameras and TV screens, and irrigation fluids. It also generates liters of contaminated waste.

The surgeons in my area routinely charge $2000 for the arthroscopy and $400 for the assistant (even though basic arthroscopies do not attract a rebate for assistants).

This fee is to cover their time and expertise in the OT. They are not required to fund and maintain their own laboratory. Any tissue sampling, handling, or processing is done by a pathology company for a further fee. Anaesthetic fees are comparable for both procedures.

Regenexx procedures are probably more labor intensive than many other stem cell providers. Apart from guided injections to the affected joint both pre and post treatment to maximize the therapeutic effect of the stem cells, in the operating theatre the stem cells are always injected as close to the affected area of the joint as Conference presentation by Dr K Kahn, editor BMJ, at ACSP National conference Feb 2015 Consideration of Discussion Paper on the Regulation of Autologous Stem Cell Therapies possible using ultrasound or image intensifier guidance. When image intensifier is used this generates further costs.

There are further costs associated with licensing (which maintains a high standard of patient safety and treatment homogeneity), and the provision of pharmaceuticals from compounding pharmacies.

After everything is taken into account there is little difference between the doctor’s fees for a stem cell procedure and an arthroscopy.

The total direct cost of a knee replacement in the PUBLIC system is $20,0005 and rising. It is higher in the private system. The indirect costs of osteoarthritis to the community equate to 150% of the direct costs 6.

Executive summary The use of stem cells to treat the pain associated with joint injuries is both safe and efficacious. Even in low doses the stem cells perform an immunomodulatory activity that reduces the pain and ongoing chemical destructive changes that lead to progression of degenerative disease. Effectively this improves patient comfort, and usually functional ability, and stops the progression of the disease for at least three, and probably five years (based on Regenexx registry data).

The safety of cultured stem cells has been demonstrated many times in both clinical trials and large registries when used to treat musculoskeletal problems. Even when used to treat malignancies in irradiated and immune compromised individuals’ bone marrow injections into hundreds of thousands of patients have not resulted in a significant number of serious side effects.

Recommendations

The use of bone marrow derived stem cells to treat musculoskeletal conditions fills a small niche. People recommending these procedures should understand what other treatment options are available. As this is an evolving field of medicine, although it is relatively safe, it is important that practitioners understand the importance of reporting any adverse event properly. A central registry for reporting these events is an excellent idea. Enshrining it in legislation runs the risk of doctors who make an error in their paperwork being classed as criminals.

I believe the administration of bone marrow derived stem cells should be restricted to medical practitioners with specific training in the nature and extent of joint diseases and who are used to recording and reporting the findings. It would be my recommendation that there is no need to further regulate the use of stem cell treatments for musculoskeletal procedures, but the practitioners performing the procedures to treat such conditions should have a specialist qualification in Orthopaedics, Rheumatology, or Sports and Exercise Medicine or equivalent further http://www.health.nsw.gov.au/Hospitals/Going_To_hospital/Pages/Cost-of-Care.aspx http://www.deloitteaccesseconomics.com.au/uploads/File/Painful%20Realities%20The%20economic%20impact%20of%20arthritis%20in%20Australia%20in%202007.pdf Consideration of Discussion Paper on the Regulation of Autologous Stem Cell Therapies

training or experience

The greatest risks associated with the use of non-expanded stem cells come from tissue handling. Regenexx has a full suite of standard operating procedures that agree with the TGA’s code of GMP. To further regulate all stem cells as if they were a single product would be do nothing to improve on this standard and would overly complicate applications for safe and proven uses of stem cells as they become more widely available.

Consideration of Discussion Paper on the Regulation of Autologous Stem Cell Therapies Answers to Discussion Questions What are the public health risks of ‘autologous stem cells’ in your view?

There are no public health risks of autologous, bone marrow derived stem cells.

Bone Marrow transplants have been used since the late 1960’s. The American Cancer Society wrote in 2013 in a document entitled Stem Cell Transplant (Peripheral Blood, Bone Marrow, and Cord Blood Transplants) That in relation to infusion of stem cells “Infusion side effects are rare and usually mild. The preserving agent used when freezing the cells (called dimethylsulfoxide or DMSO) causes many of the side effects. … “Patients who have transplants from cells that were not frozen do not have this problem because the cells are not mixed with the preserving agent.

“Other short-term or immediate side effects of the stem cell infusion might

include:

Fever or chills Shortness of breath Hives Tightness in the chest Low blood pressure Coughing Chest pain Less urine output Feeling weak “Again, side effects are rare and usually mild. If they do happen, they are treated as needed. The stem cell infusion must always be completed.” It should be noted that these infusions are given intravenously and despite the “hundreds of thousands of people treated” none of the side effects listed in section 2 of the discussion paper appear in the American Cancer Society paper.



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