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Sudbury doc defies Health Canada order to stop performing stem cell treatment

Dr. Scott Barr has been offering the treatment to ease inflammation for more than two years
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Dr. Scott Barr. Supplied)

A Sudbury plastic surgeon is calling on representatives of Health Canada and the College of Physicians and Surgeons of Ontario to visit his clinic to see first-hand how he uses stem cells to treat patients for a variety of medical ailments.

For two and a half years, Dr. Scott Barr’s Ontario Stem Cell Treatment Centre has been offering the treatment to ease inflammation that causes pain in hips, knees and backs, and to treat lung, heart and other disorders.

Barr visited a clinic in Los Angeles some years ago for stem cell treatment to ease chronic back pain from 15 years of playing varsity football. It eased his suffering where pharmaceutical and other treatment modalities could not, and he set out to offer it to patients in Sudbury. He also operates Barr Plastic Surgery, where he performs esthetic procedures, which are the bulk of his practice.

Last week, Health Canada ordered three dozen clinics like Barr’s in Canada to stop offering stem-cell and platelet-rich plasma injections to patients. 

Health Canada argued that removing stem cells from patients and then transplanting them back to them was modifying the cells and says doctors like Barr are essentially manufacturing a drug. 

Barr dismisses that theory and is continuing to offer stem cell treatments, defying the order from Health Canada.

He said this week that he has reached out to Health Canada and the college that regulates doctors and surgeons in Ontario and invited them to come to his clinic and watch him perform stem cell procedures. So far, neither the federal department nor the college has responded to his requests.

Barr participated in a teleconference with the CPSO last week to “make sure that everyone understands what we’re doing and make sure that there’s no misunderstanding. I think that’s the biggest problem right now ... (it’s) just a misunderstanding.”

CPSO spokesman Shae Greenfield said the college cannot comment on individual cases. 

In a statement, CPSO general counsel Carolyn Silver said the college is continuing to work with Health Canada, which is responsible for approving treatments like the ones Barr is offering. The college’s role is to ensure physicians are meeting the standard of practice of the profession.

“Should the College receive information that a physician is not complying with a specific direction from Health Canada, we would need to consider what steps to take to ensure that the public is not being put at risk,” said Silver in the statement. 

Barr said while he was contacted by Health Canada and told to stop offering the treatments, he was earlier advised by the college to use his clinical discretion about whether to offer stem cell treatments.

He believes one other clinic in Canada, the Vancouver Stem Cell Treatment Centre, is also continuing to perform the procedure. Barr’s clinic does about 150 stem cell treatments a year, a tiny portion of the “thousands and thousands” of mostly esthetic procedures he performs at Barr Plastic Surgery.

The pain of arthritic conditions is the main reason patients contact his stem cell centre, he said.

As people age, their bodies take “a significant pounding,” particularly if they have been involved in sports and been very active. It is believed that stem cell treatments can ease the pain and especially the inflammation these patients suffer, and improve their quality of life.

Only 16 per cent of the people who consult with the Sudbury centre are approved for stem cell procedures. The treatments are not covered by the Ontario Health Insurance Plan. Patients are typically treated by intravenous transfer and injections of stem cells into affected areas. The cost of stem cell treatment for both knees is about $6,500.

Barr explains that when stem cells are injected in knees, they first “settle down” the normal inflammatory response of the body. That can be proven.

The other mechanism that is “thought and again not proven, but thought” is that stem cells possess the ability to turn into other cell types such as cartilage cells or lung, heart and liver cells. It is thought that the body may have a mechanism to facilitate that process once stem cells are reintroduced to tissue.

“So we’re not saying that they make cartilage” but some speculation and research indicates they may. In research laboratories, stem cells are placed into other mediums to “modify themselves” and become like other cells, said Barr. His clinic is not doing that kind of procedure and that may be a misunderstanding on Health Canada’s part. “They may feel that we’re modifying the cells but we’re not.”

Health Canada is telling Barr and others that they are manufacturing a drug and that they are not allowed to modify cells.

“My response is, ‘we’re not modifying them at all and we’re not manufacturing a drug.’ We’re basically taking cells from a human being and putting them back into a human being.” 

If anyone were to be held responsible for manufacturing the cells, “Health Canada would have to give the patient a fine because we haven’t done anything,” he said.

The first stem cell transfer was done in 1956 to treat cancer, but it’s a very different process than Barr is using at his centre and he is not trying to equate his treatments with those for cancer.

Barr said Health Canada is upset with clinics such as his for manufacturing a drug, but plastic surgeons have been transferring fat cells for decades. Fat cells are rich with stem cells so they have been getting transplanted with fat for years.

If “there was a problem transferring a stem cell, we would have known about it by now,” he said.

Critics argue the use of stem cells is unproven and unsafe.

“I would say they may not be proven enough, but there’s many, many cases where there’s significant benefits from stem cells.”

About 80 per cent of the two or three patients Barr treats a week with stem cells show some improvement. “If you get a significant improvement for a significant period of time, most patients would consider that a success.” 

He cautions that for people in the end-stage arthritic stages, you’re “not going to give them a youthful joint again.”

Barr agrees more research needs to be done on the use of stem cells in procedures such as the ones he offers. And he tells patients up front they don’t work for everyone.

He has had patients who have had significant improvements even in neurologic conditions after receiving three treatments. Physicians are often skeptical of these results, said Barr, attributing improvements to other factors.

“Some physicians won’t even keep their eyes open to consider that there might be some powers within these stem cells that we don’t fully understand,” he said.

Barr sees the use of stem cell transfers as a patients’ rights issue, arguing they should be free to choose treatments that may help them as stem cell treatment did for him. 

The only requirement after the treatment he received was for him to “lay low” for four hours. Within four weeks, his back pain was gone. Should it return, he would not hesitate to have stem cell treatment again.

Barr said he doesn’t want people to have an unnecessary surgical procedure and waste their money, and he wants them to understand the risks and limitations of such treatments.

He admits he tells patients he is biased in favour of the treatment because it was so successful for him.

The Sudbury surgeon only began speaking publicly about the stem cell procedures he offers after a national newspaper published an article about his plan to defy Health Canada’s instructions to stop offering them.

“We just want people to be well-informed,” he said.

Stem cell treatments don’t work for many conditions, although in countries other than Canada they are marketed as a cure-all. Barr thinks that may be why there is so much scrutiny and criticism of the treatments at home.

“This is being offered because we feel it’s a required service,” said Barr. Still, if he can’t come to an agreement with Health Canada and the College of Physicians and Surgeons of Ontario to continue offering the treatment, he may have to stop.

That would be unfortunate for patients, he said.

As he waits for replies from Health Canada and the CPSO, Barr will continue performing stem cell treatments and speaking out to clear his name. If people say he is “crazy” and the treatments he is providing are “wrong,” that is good “because it will force you to make a really informed decision.”

Barr has provided more information on his views of the procedure in a written statement. You can read that below:

Stem cells are not a drug

Health Canada has arbitrarily decided that the separation of adult mesenchymal stem cells from a patient’s own tissue is tantamount to “manufacturing” a drug, despite the fact that the stem cells are not altered or modified in any way. Only the patient “manufactures” their own cells. We are simply harvesting, washing and concentrating the cells, then placing them back into the patient to do the work that they are meant to do.

Stem cells can be obtained from different sources.  

Stem cells can be obtained from another human. These are referred to as alloplastic stem cells. A common source is fetal cord blood. We do not offer any treatments using this type of stem cell.  

Stem cells obtained from the patient are referred to as autologous stem cells.  There are two sources of autologous stem cell: bone marrow derived stem cell and stromal vascular fraction (SVF) derived stem cells obtained from the most superficial layer of adipose tissue (also referred to as fat).

The procedure to obtain bone marrow derived stem cells is uncomfortable.  The stem cell counts are in the range of 500,000 per cc. The availability of these bone marrow derived stem cells drops after the age of 55 years in all patients.  

In contrast, SVF derived stem cells are more abundant and the procedure is painless. The stem cell counts are in the range of 30 million to 99 million stem cells per cc. Unlike bone marrow derived stem cell, the counts in SVF derived stem cells do not decrease in older patients.  We have treated patients in their 80s with counts in the range of 66 million stem cells per cc.  

During a stem cell treatment at the OSCTC, a small amount of local anaesthetic is placed into the skin. Through a 4 mm opening, more dilute local anaesthetic is placed immediately below the skin in the extremely superficial fat layer. This layer is rich in stem cells.

They are referred to as SVF (stromal vascular fraction) stem cells. Only 54 cc is harvested. They are concentrated and incubated for a short period of time.  

Following this they are washed multiple times to ensure that we have only concentrated pure stem cells. These stem cells are placed in a cell counter to determine total stem cell counts and viability. Depending upon the condition that is being treated, stem cells are returned to the patients using treatment protocols that optimize the potential impact of the stem cells for that patient.  

For many decades, surgery has involved the separation or dissection of cells, and the method and degree to which that could be done has been dependent on available technology.  

Ten years ago, it was unorthodox and frowned upon to provide lipo-transfer (fat grafting) to breasts. Fat grafting moves fat from one area of the body to another. It is now considered the gold standard of care and a surgeon is thought to NOT be providing standard of care if he/she does not offer this procedure.  

In fact, fat grafting has been performed for over 30 years. It has been shown that the fluid collected from lipoaspirate during a liposuction procedure prior to fat grafting is loaded with mesenchymal stem cells. 

This means that surgeons have been removing and injecting patients’ fat and free-floating stem cells for over 30 years. If there were risks from injecting your own fat and stem cells after separation, we would know about them by now.  

While it is obvious to anyone that critically assesses our stem cell process, that we are not “manufacturing a drug,” in the event that Health Canada insists that we are, we are exempt by their own position statement because our surgical procedure and protocols utilize lymphohemopoietic cells and do not modify them in any way.  
  
If a patient’s own stem cells can’t be considered a “drug”, isn’t their reparative power at least “equal” to a drug? 

No. There is no drug or surgery that can actually HEAL a patient. Only cells can actually finish the healing process - without a functional immune system, no drug or surgery can result in a healthy or recovered patient. Since only a patient’s cells can heal, they are not equivalent to drugs - they are superior. That does not make them equal and should not mean they can be owned or controlled by anyone other than the patient.  

Health Canada has confounded our personal cells with drugs by suggesting that, because stem cells can cure, treat, diagnose or mitigate a condition or disease, they can be labeled drugs for regulatory control.

Surgery is also performed to accomplish these goals, but no one would label surgery a drug. It is ironic that, because stem cells are capable of these amazing feats, physicians are being banned from providing these treatments. Indeed, a physician’s goal every day is to do just that – diagnose, treat, mitigate or cure a condition or disease.  

By confounding cells with drugs, Health Canada is suggesting that your cells must be evaluated and produced just like any mass produced pharmaceutical.  This is non-scientific, arbitrary and detrimental to patients.

Our clinic

I have had a very busy private surgery practice for the last 24 years prior to offering stem cell treatments. We offer them in our clinic solely because a stem cell treatment I received in California, using the same system and protocols I now offer to patients, freed me from debilitating back and leg pain and significantly improved my quality of life.

For the five years leading up to my stem cell treatment, I tried all conventional medications, physiotherapy, inversion tables, and non-narcotic analgesics, yet experienced little to no relief.  

Unless you live with chronic pain or disability, you cannot truly appreciate the devastating impact these conditions can have on your personal and professional life.

After experiencing the dramatic improvement in my symptoms within four weeks of my stem cell treatment, we became committed to being part of the regenerative medicine revolution and to bringing these treatments to patients in Ontario.

We joined the Cell Surgical Network (CSN) and became one of hundreds of affiliates from all over the world and all areas of medicine who also wish to further the research and progress of regenerative medicine using stem cells.   

Prior to investing in the equipment, training and staff involved in offering these treatments, we did seek the guidance and approval of both the College of Physicians and Surgeons of Ontario, and Health Canada.  We did receive both verbal and written guidance from both organizations.  

Who can benefit from stem cell treatments?

Since we started providing stem cell treatments 2.5 years ago we have had many hundreds of patients contact our clinic to discuss stem cell treatments for themselves or their loved ones.  While there are conditions that may respond very favourably to stem cell treatments, there are some diseases and medical conditions that evidence has shown cannot be improved or changed by stem cell treatments.   

With every patient, a thorough intake history is obtained and assessed.  For those whose medical situation is such that the likelihood of a stem cell treatment offering noticeable improvement is low, we do not offer stem cell treatments.  As you can imagine, for many patients, this can be devastating information. 

For those with conditions that may respond favourably to stem cell treatments, we send them the CSN statistics on historical response rates related specifically to their condition.  If the patient decides to proceed with a consultation, one is arranged.  The consultation is informative and honest.  The risks, benefits, limitations and stem cell procedure are discussed in great detail.  

At the completion of the consultation, the patient is asked to do more research, discuss the information that has been provided with their primary treating physicians, and seek additional information on their own.  If they decide to proceed with a stem cell treatment, they contact the office and it is arranged.  

As a result of this comprehensive process, our initial contact to actual treatment conversion rate is approximately 16%.  It is our opinion that only a well informed patient is able to decide if they want to use their own stem cells to treat their condition.  

Stem cells have an excellent safety record

Since starting stem cell treatments, we have not had any complications with our own patients.  

A safety paper of the CSN affiliates followed patients that underwent stem cell treatments for knee and hip arthritis from 2011 to 2016.  1686 treatments were performed and resulted in no significant adverse events or complications.  There were 2 cases of skin irritation at the donor site.  

Every patient that gets treated with stem cells at our clinic is advised that they are contributing to patient funded research should they decide to proceed with a stem cell treatment.  Each patient is contacted by the CSN at one week post treatment and every 3 months thereafter for 5 years to assess their response to their stem cell treatment.  It is this global accumulation of patient data from within the CSN that allows other patients to determine if the stem cell treatment they are seeking may be of potential benefit to them. 

In contrast, many “approved medications” and “approved devices” have serious “acceptable” health issues.  An example is the approved biologic agents.  These cause a significant lifetime increase in cancer and can leave patients with a suppressed immune system and increased susceptibility to infections.  

Real patients with real results

We have many patients who have experienced a significant improvement as a result of the stem cell treatments that they have received.  Like all treatments and surgeries that patients can receive, there are also some patients who have not experienced benefits.  

I personally have a complete resolution of my back pain as a result of one stem cell treatment.  

The vast majority of our patients who have undergone stem cell treatments for arthritic conditions (knees/hips/shoulders) have experienced a significant reduction in their pain and an improvement in their joint function as well as quality of life.  

Some of our COPD patients have enjoyed an improvement in their pulmonary function tests after stem cell treatments. We have patients with neurologic conditions and diffuse inflammatory conditions that have experienced significant improvement in their condition and a resolution of many of their symptoms.  

While critics of our stem cell treatments would refer to these as anecdotal stories, the overwhelming response of the majority of these patients, after they have exhausted all conventional treatments, suggests that stem cells are a viable option for many.   

Most knee and hip patients have exhausted all of the Health Canada approved medications, surgery, and physiotherapy options and are awaiting a total joint replacement.  

Eighty per cent of these patients experience some to significant improvement in symptoms after their treatments, which speaks volumes about the reparative power of a person’s own stem cells. If any “approved” medications and devices had this degree of success, many of these patients wouldn’t need to seek stem cell treatments.

In the future, I expect stem cell treatments will be first line treatment and physicians will be able to treat and possibly even cure patients before they get so far along their degenerative course.  We are doing these treatments because they work for many patients and it is a patient’s right to seek out medical treatments and decide for themselves if this is a treatment they want to pursue.  In my opinion, stem cell treatments will become one of the greatest advances in medicine in the next decade.

Big Pharma and Stem Cells

No one is saying stem cells do not work; in fact pharmaceutical companies are spending hundreds of millions of dollars to try to “create” stem cells and commercialize them.
 
If the pharmaceutical industry could find a way to own our personal cells and attach a DIN (Drug Identification Number) to them, they would have done it long ago. The reality is that every human’s cell is unique and owned by that person.  In general, the formulation of a specific drug is identical each and every time.  Stem cells are unique to each and every patient. This is yet another reason why stem cells are not a manufactured drug.  

Only the patient manufactures and owns the cells in their body, so the patient should have the right to decide what to do with them. No one else should have the right to deny them the use of their own property to alleviate pain or improve the quality of their life.  
 




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