May 2017

Dr. Duncan Stewart: "Be wary of any stem cell therapy that is fee-based and has not been validated through a complete clinical trial process."

More doctors treating aching joints with stem cells, even though treatment is costly, unproven and relief is only temporary

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It’s expensive, only temporary and lacks gold-standard proof that it actually works, but stem cell therapy for bad knees, hips and shoulders is taking hold in Canada.…

It’s expensive, only temporary and lacks gold-standard proof that it actually works, but stem cell therapy for bad knees, hips and shoulders is taking hold in Canada.

“The future is obviously injections of biologics,” says Dr. Tim Dwyer, an orthopedic surgeon at Women’s College Hospital in Toronto who has treated 20 patients’ faulty joints with stem cell injections at his private clinic. “One day we will look back and think joint replacement was a fabulous solution 30 years ago that now is quite a barbaric approach.”

We have written about these autologous (using a patient’s own stem cells) transplants in this space before. The first type, bone marrow aspirate concentrate (BMAC) therapy, involves extracting stem cells from a patient’s pelvis and spinning them in a centrifuge before re-injecting the refined cells in the damaged joint. The second type, formally known as stromal vascular fractioning, involves removing adipose (fat) cells via liposuction, running them through a centrifuge to collect the stem cells and re-injecting them in the patient’s ailing joint. Both are usually done on a same-day outpatient basis.

Neither treatment has been proven effective in large scale, randomized controlled clinical trials in which one group of patients gets the treatment and another gets a placebo — with neither group (nor the researchers conducting the trial, for that matter)  knowing who got what until the data is collected and analyzed.

“That is correct, not at this stage,” says Dr. Dwyer. “We’re basing (the use of the treatment) on cohort studies looking at BMAC in the knee especially.”

Dr. Jas Chahal, a colleague of Dr. Dwyer’s at Women’s College Hospital, believes there is “good basic science,” to support the use of stem cell treatments for knees, hips and joints afflicted by osteoarthritis or damaged by injury. “BMAC has various factors in it that probably help inflammation and pain control. There is emerging clinical evidence in the form of case studies, groups of 10 or 20, who have had it and after 12-month follow-up had good results.”

However, Dr. Duncan Stewart, the President and Scientific Director of the Ontario Institute for Regenerative Medicine, says patients “should be extremely wary of any stem cell therapy that is fee-based and has not been validated through a complete clinical trial process.

“Clinical trials exist to establish not just whether a treatment will work, but to ensure it is safe for the patient,” says Dr. Stewart, CEO of the Ottawa Hospital Research Institute and a leading authority on stem cells who has led or collaborated on more investigator-initiated cell therapy trials than anyone else in Ontario. “There are many promising stem cell therapies out there that are currently in clinical trials, but not all will approved for clinical use – and the only way we can know for sure is by collecting the proper data through a clinical trial that has regulatory and ethical approvals.”

For Dr. Dwyer, who sees the BMAC treatment as more effective but will provide the adipose-derived stem cell treatment for patients for whom BMAC isn’t appropriate, stem cell injections offer an option where none existed before.

“For 10 years of my career I’ve had to say ‘You’re too young to have a knee replacement and a knee scope won’t make you better, so there’s nothing we can do.’ That’s not a fun conversation to have three or four times a day.”

He charges between $3,000 and $3,500 per injection, none of which is covered by the provincial health insurance plan or by private insurance.

Some researchers and clinicians have taken things a significant step further by taking the BMAC cells and, instead of just running them through a centrifuge, culturing them in a lab to vastly increase the number of stem cells they can re-inject into the patient at a later date. But these treatments are significantly more expensive. Dr. Chahal is part of a team conducting a clinical trial extracting the mesenchymal bone marrow stem cells from patients and doing this kind of ex-vivo expansion and then re-injecting them at concentrations of 1 million, 10 million and 50 million cells. Researchers are currently collecting the data.

Of the 20 patients Dr. Dwyer has treated with the same-day therapy, “a couple” saw no improvement in their conditions. Most report feeling better. “Just yesterday I saw three people — two shoulders and a knee — and they were actually ecstatic. Now that’s just a cohort. But it certainly helped those people and they’re at the six-month mark.”

He points out that joint replacements are also not a sure thing.

“It’s not guaranteed that a knee replacement will help. Some 20% of people still have pain afterwards. And there’s always the chance that you get an infection, which can be a disaster. A lot of people, including myself, think that joint replacement is a last resort. So, obviously, having an injection that might take the pain away for a year is a very attractive option.”

Pain relief, if achieved, likely will be only temporary, says Dr. Dwyer. “We’re looking at a year,” says Dr. Dwyer. “For some people it will be more, for some it will be less. It will be something that you will need to have repeated. But if you ignore the financial cost of it, which is a significant factor obviously, and just look at whether you would like to have an injection once a year and not have a knee or a hip replacement, the answer is easy.”

BMAC and adipose stem cell treatments for arthritic and damaged joints have been around for about a decade and are widely available across the United States, with many Canadians travelling there to undergo them, sometimes paying exorbitant fees.

Here at the Canadian Stem Cell Foundation, we get more patient enquiries and blog comments about stem cell treatments for failing joints — be it from either osteoarthritis or injury or overuse — than any other single condition. People are both intrigued and suspicious and are looking for guidance.

What is Health Canada’s position on the use of bone marrow aspirate concentrate injections/transplants to treat knees and hips?

The Office of Policy and International Collaboration at Health Canada’s  Biologics and Genetic Therapies Directorate  responded by email to say that “in some cases, autologous cell therapy products that are processed for a particular patient by a regulated health professional pursuant to the scope of their practice may not require federal pre-market regulatory authorization under the Food and Drug Regulations. They added that, based on the information we provided, “we do not have enough information to make a determination regarding the regulatory pathway that would apply to BMAC.”

Prof. Leigh Turner, a Canadian who is an Associate Professor at the University of Minnesota’s Centre for Bioethics, has followed the proliferation of clinics offering BMAC and adipose treatments in the United States. He says it’s “premature” for Canadian orthopedic surgeons and other physicians to charge for “so-called stem cell treatments” administered to patients with joint problems.

“Safety and efficacy of such interventions still needs to be evaluated in carefully designed and properly conducted randomized controlled trials,” says Prof. Turner. “Such studies will have to address whether stem cells obtained from BMAC, adipose tissue, or other sources are optimal when treating patients with osteoarthritis. Carefully designed clinical trials should also provide meaningful information about dosing strategies, optimal mode of administering cells, and the frequency with which injections will need to be provided.” And all that, says Prof. Turner, is conditional on stem cell interventions beating placebo during the randomized controlled trial process.

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Sep 2016

Dr. Shane Shapiro

Jury still out on BMAC treatment for knees

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Back in February, we  reported on how thousands of people are visiting hundreds of clinics in American cities and some Canadian centres to  get an expensive, unproven, same-day stem cell treatment to ease pain and restore flexibility in their arthritic or banged-up knees.…

Back in February, we  reported on how thousands of people are visiting hundreds of clinics in American cities and some Canadian centres to  get an expensive, unproven, same-day stem cell treatment to ease pain and restore flexibility in their arthritic or banged-up knees.

The BMAC (bone marrow aspirate concentrate) procedure involves extracting mesenchymal stem cells from a patient’s pelvis, spinning them in a centrifuge and then re-injecting them into the damaged knees. The treatment can cost anywhere from $2,000 to $10,000 per injection, even though there are no published reports from high-level clinical trials to indicate it works.

We are, however, getting  closer to knowing the truth.

Dr. Shane Shapiro, an orthopedic surgeon at the Mayo Center for Regenerative Medicine in Jacksonville, Florida, has published the results of a 25-person clinical trial in which patients with osteoarthritis received  an injection of stem cells in one knee and a saline solution placebo in the other — unaware of which was which.

The results are less than conclusive. As reported in the American Journal of Sports Medicine:

“Study patients experienced a similar relief of pain in both BMAC- and saline-treated arthritic knees. Further study is required to determine the mechanisms of action, duration of efficacy, optimal frequency of treatments, and regenerative potential.”

According to Dr. Shapiro, this leads to two possible interpretations. One is that the BMAC procedure was no better than placebo (because both knees got equally better). The second is that stem cells have a systemic effect (which some animal and human studies suggest) and can go to where needed — so that stem cells injected into the left knee could also make the right knee feel better.

Dr. Shapiro stresses that his study doesn’t prove the latter.  It’s still just  a theory.

Clearly, what’s needed is a double-blind, randomized controlled clinical trial in which each participant is assigned to receive either the BMAC treatment or a placebo by chance with neither the patient nor the doctor knowing who gets which so that the results can be objectively compared. Until then, we won’t know whether the BMAC procedure actually relieves pain and repair knees.

It should also be noted that the Mayo clinic used the most promising stem cells for their injections. Instead of just drawing and concentrating bone marrow and then reinjecting it into the patient,  Dr. Shapiro’s team tracked the number of stem cells and tested their viability before injecting them into a patient’s knees. A patiently likely would not get that level of quality assurance from a busy clinic trying to treat as many patients as quickly as possible.

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