Webinar: Regenerative Medicine & Chronic Pain

Teaching Your Body to Heal Itself

Employers estimate that 36% of their overall benefit plan costs are attributable to chronic conditions. The real number is likely much higher. Regenerative medicine helps alleviate chronic pain to reduce the reliance on pain medications. Learn how stem cell therapy can teach your body to heal itself in this webinar featuring Dr. Riam Shammaa, MD.

Dr. Shammaa specializes in regenerative and translational medicine and conducted the first successful spinal disc repair using stem cells in Canada. He also pioneered non-surgical knee repairs for avascular necrosis using stem cell transplants.

Webinar transcript:

Kim Wolf:Welcome everybody.


We will bestarting our Regenerative Medicine and Chronic Pain: Teaching Your Body to Healitself Webinar. I welcome all of you in joining us today. Thank you very much.We saw a lot of activity about this event over social media. I'm really gladthat you've been able to join us.


My name is KimWolf and I will be moderating this webinar today and I'd like to welcome Dr. RiamShammaa who is with us. He's gonna tell you a little bit about his background, aswe move forward. Just to tell you a little bit about myself and why I am here.My background is consumer goods and food. I have had some senior leadershiproles in some big and small companies.


I think that thistopic is extremely relevant to us. We're gonna talk today about how science is tacklingthe issue of chronic pain proactively. We hear about a lot of those things insocial media and on the news, we're gonna talk about that directly today. Also,about early intervention and how that can proactively manage corporate costsand the impact that it can have to your business, and then also how earlyintervention can raise the quality of our lives.


On to the nextslide, when I was first asked to moderate this event, my first thought was Idon't have a background in medicine and I thought I'm not really sure if I'mthe best person to moderate this but I started looking into it. I saw thedoctor's presentation and I thought, "Oh my gosh! this is so relevant to whatI do," as I said, my background's in consumer goods and foodmanufacturing. I've also worked in engineering for a number of years and hadsome senior leadership roles with companies.


I really dobelieve that what we're going to talk about today can have a direct impact toour businesses and why it's so relevant. I just put a couple of points togetherhere for us to kick off our webinar today. Being able to keep employees atwork, we know that most people do better when they're not sick. When they areat work and not at home for long periods of time. I'm keeping our productivityand our efficiency results high when you've got the employees who have theexperience and the training in your facilities and in your companies. That is,when you're going to be able to achieve your company goals the best, reducingabsenteeism, of course and having to find replacements.


We all know thatcan be a very difficult cycle to break and to get out of. But again, whenyou've got your own employees there who are doing their jobs, we are going tobe at our at our very best. Increasing employee engagement and motivation, we doknow that when people are hurting, when they're depressed because they don'tfeel well, when they're not healthy, it certainly has a direct impact toemployee engagement and their motivation at work and that can saturate across awork environment very quickly, driving employee accountability and inclusion inthe company's success.


When we're askingmore of our employees and all of us are. I don't care what business sector thatyou're in right now, we're all asking our employees to step up and and be apart of driving our company's results and ultimately success. When people are hurting,when their mind is elsewhere or even if they have a loved one at home who maybe in chronic pain and that's where their thought process is, they're notreally focused on work and so they're not going to be able to give a hundredpercent at work.


Of course,keeping that medical insurance costs low, that's so important. Early intervention,I'm a big believer personally on proactive medicine and early intervention. Andthis certainly, what we're gonna talk about today, falls into that category aswell and then driving safety results. If you have people who their mind iselsewhere or physically they're not able to do their job that can have animpact with resulting in an accident.


We certainlydon't wanna have that happen and we know the WSIB impacts as well, the impactto your workforce. I really am very excited about this webinar today. You'regoing to hear some really exciting information about some alternatives and that'swhat we as employers can do, is educate ourselves about the alternatives thatare out there, so that we can best support our employees. With that, I willturn it over to Dr. Riam Shammaa. His webcam is not working today. He's havingsome technical issues but you do see a picture of him in the presentation whichwe will be recording and we will make sure that you get a copy of that afterwe're finished today. So with that doctor, I'll pass it over to you.


Dr. Shammaa: Thank you Kim, thank you for the nicepresentation. Hi everyone, so my name is Dr. Riam Shammaa, I'm going to talk toyou today about the future of chronic pain and medicine and the potential ofcell therapy in tackling this huge problem in our society. With that, I justwanted to give you a quick background about myself on previous lecture at theUniversity of Toronto. My expertise are in "Cell Therapy andBiologics".


We do a lot oftranslational research and driving a lot of those Biologics to the clinic. Also,the founder of CCRT, the Canadian Center for Regenerative Therapy and onecommercial involvement is I'm the founder and the CEO of IntelliStemTechnologies. It's however, Biotech company with breakthrough technologies forcell therapy in catastrophic diseases, so cancers and infectious diseases suchas malaria, it's not related to our presentation today. And this drives me tomy disclaimer that I have no financial bias or commercial benefit from thispresentation. All what you see today, is driven by data and science that wepublished from papers in our work in the last 10 years. With that, I'll juststart talking about Osteoarthritis and Pain Medicine and the majority of theproblems that we face are back pain or what we call - degenerative discdiseases and osteoarthritis, one of the two most common problems in the world.The economic burden of Osteoarthritis is roughly 80 billion dollars annually.Now, the problem catapulted to the front with the improvement of quality oflife with many advances in medicine except in this field. Unfortunately,surgical interventions still are what we call the gold standard and unfortunatelythey are very limited in their capacity to control pain or improve quality oflife in that matter.


Unfortunately,they come at a last resort where we either replace a joint or do a fusion onthe spine and those are drastic surgeries with very limited success andoutcomes. Now, the Hillstone Therapeutic, it's a Canadian initiative that westarted in collaborations with top universities and the government in the lastfew years. The idea is to introduce a Cell Therapy to the field so we candisrupt Pain Medicine and introduce alternatives that are viable in improvingpatients life, driving down costs and and improving clinical outcomes.


Now, just to giveyou an idea about how big the problem that we face in the world. Usually, 15percent of the world is diagnosed with Osteoarthritis. The burden ofOsteoarthritis goes beyond the suffering of the patient. It goes from theirdisability, a lack of capacity of mobility, being bedridden, and this leads tosubstantial problems. They start with decreasing the quality of life of thepatients, their inability to actually perform and that leads obviously to declinein their function, severe pain and even mental health issues. On the other sideof the equation, the economic burden is massive not only because of the loss offunction of those people in the society but also the burden that leads totaking care of them as well in the field.


Now, one of thethings that we see in the field is one not only the cost that we see annually onthe system but also the disability cost by employer that reaches astronomicalnumbers. 9.1 billion dollars annually, because of that, and what we see, whichis one of the saddest stats we find in the field, is that a patient that is away of work on disability for a year, has 80 percent chance of never gettingback to work. And this leads to a huge financial burden on the system and webasically say, we lost economically and socially that patient to disability. Now,I just want to give you a quick snippet about the unfortunate journey that apatient lives through with Osteoarthritis or severe back pain. I know a lot ofyou probably are gonna relate to a certain degree. Usually, if we were in alive presentation,


I asked people toraise their hand - if they never had ever back pain in a short period of timeeven in their life and it just allow us to see how relevant the problem is inour society. Now, the journey starts with the diagnosis of Osteoarthritis whichusually leads to what we call the "pill solution". A lot of patientsare used to antibiotics and the concept that a pill will solve the problem. Youstart with having some anti-inflammatories and Tylenols trying to solve it. Butwithin a couple of years we know that, they stopped working and patients slowlywith time, start finding themselves on opioids or steroid injections or otheralternatives such as Hyaluronic Acid, but the journey does not have anysolution. It just keeps escalating from there, whether falling into the trap ofhigh doses of opioid and building tolerance all the way to eventually resortingto a knee surgery. In fact, when we use a knee as an osteoarthritis solution,we see that many of the patients even continue to have or suffer from painafter having the surgery. Now, the financial burden not only on the system buton the society in general as you saw is around 80 billion dollars. But the costof the surgery alone is about 40 thousand dollars and that's after a 10-yearjourney of severe pain in back pain. Even the problem is more accentuated bythe lack of solution that you can't even replace a joint.


So the onlyalternative left is joint view as spinal fusion which doesn't yield a highsuccess rate. The average success rate is about 40 percent in spinal fusionsand the problem we see is not that the success rate is only 40 percent but becausewhen it doesn't work, there is actually a high failure rate where patients feelworse. It's not like, if they don't feel bad, it's just they haven't lostanything. This increases the traumatic problem that the patients face over thelong period of time.


To give you anidea about Cell Therapy and where we find potential solution, just a quickbackground about Stem Cell. They were actually discovered in Canada in 1964 butnot until Friedenstein was able to identify them and describe them with theircapacity to form colonies. Now, it went through history, all the way fromidentifying certain types of stem cells like MSC's or HSE's hematopoietic stemcells, all the way until Yamanaka won his Nobel prize on stem cells in 2012.However, one of the most important moments in history and I highlighted thathere, is the work of Hernigou, who transplanted the first Stem Cell Therapy ina patient with a sickle cell anemia. That patient had a necrosis and hesuccessfully was able to regenerate the joint and kind of usher the new era ofclinical applications of Cell Therapy.


Now, the problemwe see just like in any promising field is what we call the "Gartner HypeCycle". You have something very promising and great potential, you see alot of fake lanes, a lot of you can call snake oil sellers. There's a lot oflack of evidence in many of the claims that happened in the field and that wasunfortunate. But I'm the kind of person who actually sees the positive side ofthe equation or the full size, full part of the glass, if you will. By knowingthat, all those kinds of hypes are going to fizzle eventually and what's goingto stay is just the real potential of Cell Therapy in the field . In fact,indeed in the last few years, we have seen the FDA cracking down on all thosefake claims and all people that are claiming that the "M" word inmedicine which is a Miracle because there is no such thing obviously. We haveseen this now, not only from the regulatory bodies but as well as the educated patientsare able to understand that, if it's too good to be true, it is indeed too goodto be true.


With that, whatwe're gonna be talking today is what we refer to as evidence-based peer-review science,so all the science and the research I'm showing you today have been publishedby peer-reviewed journals. It's available on the NIH website, it'speer-reviewed and there was no financial interest in the publications of thosepapers. You gonna see and they're available to the public. You can access any ofthose papers that I have here or we presented or we're gonna be presentinghere. Now, I'm not gonna dive into the science of stem cells. I know it's notthe scope of this but just to give you an idea of when we look at stem cells,what we're looking at when we treat the patients. What we try first to confirmthat what we're harvesting is the actual stem cells and we see that those peaksand you see that in the colors, for example, the red how it differentiates fromthe gray.


After that, we'reable to confirm that those cells differentiate. They do create cartilage in thelab, they do create adipose and bone. We're also able to confirm their capacitysuch as an anti-inflammatory IDO activity. Their flow cytometry, were able tosecrete the right cytokines, they're able to proliferate properly. This give usa very good understanding of what we call the quality attributes of the cells.This is something the regulators also love to see, which means you're definingvery well what you are treating your patient with. In case you have any sideeffects or problems, then you're able to identify how to react.


Now, thehypothesis, we started with seven years ago for this project was, "Are weable to change the course of Osteoarthritis from the journey that you saw inthe past using Cell Therapy towards either prevent a totally joint replacementor at least delay it by five years?". Obviously, the ramifications of sucha therapy was hoping to have multiple positive aspects, be able to get rid ofthe surgery, decrease the pain, improve the quality of the life of patients. Onthe tissue side, we were hoping to regenerate the tissue itself, be able toheal those injuries, reduce the cost of the system and prevent or even delaysurgery which was an acceptable outcome for us. Now, what was interesting inthis field and it's actually unique to the osteoarthritis field is, this is oneof the few fields that the cost of Cell Therapy, which is usually veryexpensive is less than the gold standard. The cost of treatment on the systemusing Cell Therapy is actually less expensive than the surgeries.


From asocio-economical perspective, it made sense for us to do those studies. Withthat, I'm going to start with the first study that we did. We looked here at acomparison with one of the standards which was an injection in the knee versususing stem cells in the knee as well. Obviously, we have done many otherjoints, Hip is one of the second ones but when we collect data it actuallytakes us a long time. It takes us more than five years to show a data of oneyear just because of complexity of a quality assurance, data adherence,follow-up of patients of a study.


We found thatwith patients that we were able to treat their knees over one year, we wereable to reduce the pain by 60 percent. What that translated to in terms of thequality of life was 90 percent improvement of function. Those patients thatwere suffering from decreased mobility and capacity and ability to go to workfound themselves in a much better position, to find themselves able to not onlywalk but as well go back to work and have their life back and have substantialreduction in the suffering of their pains.


Now, one of thebiggest papers, it was actually the first in the world and was the study thatwe did on the spine. We took stem cells from the patients, we were able toinject them into the discs of the patients, we repaired their discs using thestem cells from the patient themselves. Now, this is a breakthrough study, neverdone in the past. What we found was a consistency in the success that we found interms of pain reduction. Indeed, we were able to reduce the pain over a year by60 percent again. What's interesting, is we always use it one year as a metric.However, we do have the two year and the three years usually come up infollow-up studies after we're able to show the data. You're going to seeprobably a patient after I have a case report which we followed the patient upto five years and indeed it showed that sustained improvement of quality oflife.


What thistranslates to meaning, when we treat a patient using cell therapy, we're tryingto fix the problem in a sense, I know it's a strong word to say because we dounderstand the complexity of the human disease and that's why when a lot of mypatients feel very good after a year and they're they have their life backtoday they tell me, "Are we gonna get bad again? ". And the shortanswer is "Yes". I use the analogy of cars quite often, but if youfix your tire this doesn't preclude it from being damaged again and doesn'tpreclude it from having a damaged tire somewhere else. The same thing here,when we fix a joint or a piece of cartilage, then with aging and mobility andactivity, that doesn't prevent from having other injuries.


But what we seeis, patients who are able through rehab and sustained activity to maintain agood healthy quality of life are able to sustain the relief that they get andthe regeneration over a long period of time. And that in fact, we were able tosee in those studies, not only we saw that improvement and function ofpatients, in this case, with the spine, we saw 60 percent improvement.


But when welooked at the MRI imaging, after a year it did show that we were able toregenerate 90 percent of the discs. The discs that were degenerated able toincrease their height, we widened the spinal canal, we saw that sustained evennow, we can say, on the unpublished data up to two years. In fact,pathophysiologically just makes sense the moment that, after three months thatthe disk has been repaired, it's not gonna go back after that, It just sustainsits integrity.


What's funny, wealways tell our patients is that figuratively speaking you are going to gainthree millimeters in height, that may help in your narrative, if that'ssomething that you would like to tell people. It's always interesting to mebecause I wear two hats, I wear a physician hat and a scientist hat, and it's avery unique and privileged position because while I deal a lot with data, weare able to also see the lives of patients change. And probably today, you wereseeing just graphs showing people what is a 60 percent or 90 percentimprovement in quality of life but it doesn't translate to you to patients thatwe see day to day. This is one of the papers we published, it was a big paperthat was two years ago, it was about one of the patients that had a substantialimprovement.


This lady was an18 year old that had an advanced necrosis, arthritic necrosis in her joints. Itwas a lupus patient that ended up on high doses of steroids because of theproblem. When she walked in my office five years ago, in fact, she was in awheelchair completely lost her capacity to walk. There was a complete loss offunction, she couldn't go to work anymore, she couldn't go to school, shecouldn't even walk around.


In fact, thatpaper when we published, and I'll show you after the treatment when we followedup on her. She had substantial improvement but the reviewers of the paperrequested that they see the patient because there wasn't the concept, a pictureis stronger than a thousand words and also seeing is believing. We have thepatient consent to show you the data, this will give you an idea about thedrastic change of patients quality of life after the therapy, that issuccessful. When we say 60 or 70 percent improvement, while it sounds like acool number for us, it's really a life of a patient that we were able to gainback.


You see thepatient when she came to see us before the therapy. You can see complete lossof weight wearing capacity in the right knee and you can see that how there iswhat we call a "valgus" of the left knee. You can see how the knee isactually deformed. It's always humbling to work with younger patients becausethey are very resilient. They actually was one of the most difficult procedureswe have done because we're trying to salvage what even surgeons couldn't do.She was sent to us from a surgical team hoping that we can do anything to atleast buy her some time. Surgery is not an option for such a young patient becauseof the revisions means by the age 30 they're going to be again in a wheelchair.


That's why no onewanted to operate on the patient. What you're going to see now is six monthsafter the treatment and that's the moment the patient walked into the clinic. Thatminute still, that still gives me goosebumps. Everyone in the in the clinic wasin tears that day. You can see the full corrections of the knees and it's sucha happy story for the patient and for all of us with the success of thetherapy. She went back to school, decided to continue her education and sheeven picked up Zumba and continued her life. And that just gives you a quickidea about the huge impact that we see with even a small percentages ofimprovement of quality of life of the patients. That would let us to continuecollecting old data and see the impact that we do in the field that really hadno other alternatives.


The beauty whenwe work in research and especially in case series studies, is that we collectso much data and honestly it's data beyond our capacity to analyze. I'm notgonna like bombard you with all the data that we see but we get not onlymedical data, we get scientific, we get demographic and socio-economical data onthe patients. We do have that luxury that we follow up with them over longperiod of time so the average follow-up period of a patient is about two years.We have patients up to seven years right now from the day we did the first procedure.Some of the lessons that we learned, that have impact on improving quality of lifeand improving the outcome of Cell Therapy is, the earlier the patient theycome, the better they get. Younger patients respond at more than 200 percentbetter than older patients.


Many patientshave that aspect of being tough or many patients are not aware of the challengesand the potentials. We saw that if they were younger, they were respondingsubstantially better. One of the other lessons we saw, is the earlier theproblem though, the better we were able to solve it. You can see that we wereable to increase the success with younger patients more than again 200 percent.So usually I tell people: "The earlier they come with the problem, theearlier the problem has been identified". And the earlier the stage of theproblem substantially, that the outcome is going to differ. It's going to givea substantial increase in the quality of life and even return to a fullactivity without pain compared to patients who are in their 70's where theyexhausted everything else, where the joints cannot be salvaged at this stage.There is only so much we can regenerate with stem cells when there is not muchany ways to work with. Some of the other interesting data that we saw forexample, some of them we use a lot in research and allowed us to identifybetter self qualities, what's differences between males to females. We noticed,for example, that females respond better than males and we do know why, I'mjust not going to take you into the physiology and the anatomy of Cell Therapyand the different type of stem cells and inflammatory cytokines. But it wasjust an interesting observation.


One of the otherobservation we saw is, the stop of opioids. Many patients were on opioids on theirown and they independently without  ustelling them, they stopped opioid. In fact, post procedure, we do provideopioids because after that the procedure is painful and we notice that 80percent of patients stop opioid on their own. This kind of speak to thenarrative that indeed, the opioid crisis was not people were trying to overdoseor seek addiction using opioids, it was a problem that was kind of catapultedto the front with the lack of other solutions. The ease of prescriptions thatmany people found themselves taking medication that they may never wanted totake from day one and the moment they had an opportunity to stop, indeed, theystopped the opioids independently.


One of the otherthings that we found, which was very interesting and we can say is a verypleasant surprise that 80 percent of patients return to work after one year ofdisability. Obviously, many of the patients that we treated were recruited inthis study, we usually require that they tried at least more than six monthsother alternatives before they qualify. This means, we end up with patientswho've been on disability for more than a year and unlike the standard averagewhich is 20 percent of patients only return to work. Here, we see that 80percent of patients voluntarily return to work after the therapy. Again, speaksto the human will and how people are actually looking forward to go back towork, if we're able to help them solve their problem and improve their qualityof life.


Two of the softeconomical data that we harvested from this was, when we do our criteria for selection,we have a grant for 100 patients only, meaning - anything out of that we're notable to cover with the study. What we saw that, many patients who did not endup in the grant, opted to be in this study and go through the treatment justbecause of what they're going through independently. We noticed that of those77 percent did not have coverage. Speaking to the problem that we see in thecommunity, in terms of coverage and plans for patients. We also saw that 80percent of the patients who did not qualify, it was not a medical issue forthem, it was a financial burden. Obviously, cell therapies are new so they endup on the upper echelon of the costs. They're not as expensive as a spinalfusion but still financial burden is substantial and while we know that in thefuture the cost drops just like anything in terms of technology, with time.


At this point, itwas a challenge for many patients and to be able to afford such therapies. Sojust a take-home message of the studies that we've done, again the earlier wetreat, the better the outcome. We see a positive outcome always for me thatpatient independently were able to stop the opioid eighty percent, returned towork after one year of disability. The challenge that we saw - economically isthat, eighty one percent of the good candidate couldn't afford it and of thoseas well they did not have even any benefit to cover for the therapy.


Now, just tosummarize this, Osteoarthritis and Degenerative disc disease are one of the biggestdisability reasons in the world in the last decade and their economical burdengoes beyond the financial aspects to disability, decreased quality of life, mentalsuffering and pain. I always like to finish on a positive note saying that, peoplewho lived for years with osteoarthritis or severe back pain no longer need tosuffer or see the grim ending but there is in fact light at the end of thetunnel. And luckily, the studies have shown that indeed Cell Therapy offers astrong potential to be able to improve the quality of life of those patients,give them restore function, regenerate the tissue and decrease their pain andgive them a happy life. And with that, I'll thank you for allowing me topresent to you today. I'll happily take questions from everyone.


Kim Wolf: Thank you somuch Dr. Shamma. It was very interesting!. I could listen about that and Ilearned something every single time that I hear you talk about it. We do have acouple questions that have come through. " What is kind of the take ofinsurance companies, are they supporting this type of treatment or whatresponse have you gotten from insurance companies?".


Dr. Shammaa: We noticed that, the only insurancecompanies that paid for it was because the patient had a health expense. Thosepatients who had health expense had that luxury to actually spend that money onwhatever they wanted. I mean, it's no secret that when you have specificbenefits, patients actually rush to finish the benefit even though beyond theyneeded. So, that's the most take-home message that I got from our patients thatwas even logical to them, they said - they have health benefits, they had theluxury to use the money to any medical procedure that they saw fit for them.Beyond that, most insurance companies, they usually, I'm not an actuary or aninsurance expert. They look at a sheet of paper and if that procedure is notincluded there, it's not covered for them.



Kim Wolf: Okay, fairenough. Can you talk a little bit about the journey of a person, of anemployee? How would they first know that they may be a candidate and what doesthe journey look like for them, first thinking about getting the treatment, allthe way through to maybe receiving that? What does that look like?.


Dr. Shammaa: Yeah, I will use an example of let's say a patient- late 30's like let's say, 36 years old patient started having symptoms. Thefirst key is to be able to identify the symptoms early. So, having thesymptoms, being able to diagnose those symptoms of pain, being able to diagnosethe arthritis and the need, and the earlier the better.


Your pain doesn'thave to be 10 out of 10 to seek help, two three out of ten over two. If you'rethe toughest person, two months is beyond long enough. The moment we identifythis, the next step would be to be referred to the center. What we usually do,we follow specific selection criteria that goes beyond cell therapy. In ourcenter, we don't only do cell therapy - we treat humans, we treat patientsbeyond this. This is only part of the studies that we do. Meaning, if you cometo see me and let's say after two months you have been diagnosed with arthritisor severe or disc disease. What we would do is we would refer you tophysiotherapy. We would work to be able to correct anything that caused thatproblem and once that has been improved, then we look at the other criteria ofthe therapy. What has been tried there? What are you looking forward? Andpatient expectations are a serious thing, we take in medicine. The way we treatfor example, a weakened warrior is different from the way we treat someone whojust wants to guard in once every six months. For us, the highest rate ofsuccess we see with motivation of patients. If the patient is looking indeed toprevent surgery. Believe it or not, many people, they don't care.


Like I hadpatients who say, "I don't care. Just put me to sleep and fix it".Obviously, that's sub-optimal for a physician to hear that but we do hear a lotof people saying. You see that less and less. Thankfully, with people beingmore educated now about their health and that our role is to empower them andnot to fix a quote-unquote problem. Medicine is more complicated than that. Sowith that, once we look at the patient's quality of life and motivation toimprove. We made sure that through conservative therapies, we're able to fixwhat can be fixed with that disease, then we look at fixing the problem. Sothen we book them for the procedure. What I didn't show here, but it was in someof the data.


The earlier it ispatients ended up getting one dose of treatment versus the advanced cases patient,got three doses of treatment. An advanced arthritis at the end that is referredfrom surgeon we're trying to salvage anything versus a younger patient who iscoming just from an early diagnosis it requires us one treatment only. Andthen, for us honestly, it becomes much easier. Once that is being planned, weplan the treatment, the patient will get the therapy, we do the transplantation.There is a period of time where the patient is going to feel worse which isusually the first couple of weeks. It is a dose-dependent response, meaning -the more we fill that cartilage, the more we feel that disc, the better theresponse. This means that, the patients are going to feel more pressure andpain in the area as well. After the first couple of weeks, once they arebetter, we actually refer them to a post, a transplantation rehab to make surethat they don't acquire a new wrong mechanics in the body, to get an injury andwe continue to follow up with them just to see them every three months. Thatextends to years in our case but after the three to six months the patient isclear to go back to their full day-to-day activity. Usually, if they'reyounger, after six months, they're clear to go back to full activity like theywant to run, if they want to do any any sport they're welcome to do that aswell.


Kim Wolf: Great!. Asemployers, " What do you recommend that employers do to advocate for thistype of treatment for the people on their team?".


Dr. Shammaa: That's an excellent question. I have twopoints mainly: the first one is Health Awareness - let the patients know, lettheir employees know, the earlier we're able to identify problem, the better itis for them. Number two - is to be able to cover such therapies in the nearfuture. Because, it really was one of the biggest challenges we saw patients. Imean, we offer the grant but it's unfortunately always limited and it renewslike once every two years and it's very strict criteria. Obviously, manypatients fall beyond that grant and they have to cover from out of pocket andthat's really one of the biggest burden we saw the patients face.Unfortunately, millennials are, unlike baby boomers, they don't have the fundsto be able to spend for such diseases at this stage.


Kim Wolf: Okay. "Whatkind of response are you getting in Canada from the medical community, in thegovernment, Health Canada, what's their response to this point?"


Dr. Shammaa: They're actually very encouraging. I meanthere was, I want to say, scientifically, the community always leans towardsevidence and reviews and those papers. We always strive to improve thequalities of the publications with time. From Health Canada, in fact, when theycame I think few years ago, when that, I don't know if people were familiarlike three, four years ago, there were literally people selling quote-unquotevials of claimed stem cells to people almost on the street. And that was thebig process in the States and when that started leaking to Canada, then HealthCanada kind of had a very strong response and we actually encouraged that, whenthey started to tell people to be wary of all those false claims. In fact,we're working closely with them now on one of the biggest studies in the world,to be able to do an evidence-based phase three studies on cell therapies , tobe able to drive them to the market.


A lot of people don'tknow that while Health Canada is smaller and people are reluctant to file withthem because the Canadian market is small, Health Canada are in a sense likethe Japanese FDA, they actually have mechanics of applications that you won'tget with the FDA. So, two examples I'll give you quickly, something we callreal world trial, meaning you don't have to do the long arduous processes thatyou need to do that cost billions of dollars to have an approval. And somethingelse is called " conditional approvals" where if you sufficientlyshow safety and efficacy in it in a biologic, you're able to treat people andthen that conditional approval triggers if there's a serious event or sideeffects and then you take it from the market. In all, the response was veryencouraging because they do see that value and they also see that challengethat big pharma is not looking to spend billions of dollars in Canada to end upwith one percent of the market of the State. They're actually very encouragingfor us to continue with a bigger study.


Kim Wolf: If we are anemployer and we have several people on our team who may be suffering, "Whatmight we be able to do to get resources brought to our company on behalf of thoseemployees?".


Dr. Shammaa: To start somewhere that we can meet whichis, patients that have benefits let's say, or employees that have benefits.Having that first step and being engaged from the human resources aspect withthe consent of the patient in terms of the impact that they are having at anearly stage, will allow us to foresee the impact over the long period of time.If you see that the patient, after a few months are having those problems then,it will allow you to be able to foresee or even prevent successfully thatdisability because while we showed that 80 percent after a year are going toreturn to work, still you don't want to have that year of disability. That'snot only such a burden on the employer but also on the employee and it will besuch an adjustment period to even return to work after that. The moment thatthose benefits start moving in the direction that shows you the chronicity, Ithink that's when it would make sense to refer them to centers where you knowcell therapy such as like what is done in the studies we published, is able toalter at least the outcome of the suffering quite early.


Kim Wolf: Yeah, thosestatistics that you showed earlier were just amazing. I would think that companieswould be able to potentially justify that type of a benefit for employees whenyou look at what the the long-term costs could be for not providing analternative benefit for their team.


Dr. Shammaa: Yeah, absolutely! I mean, one of the interestingstories. A few years ago, Ontario government had an health innovation initiativeand we actually met with them. It was a very interesting learning experiencefor me because when we met them, first of all, I met the 13 accountants andactuaries. Zero physicians on the committee because as a government, saving istheir priority. All they cared about was, "Is the outcome better than theGold Standard surgery? Yes. Two, is the cost less? It was, Yes. "Themoment we had those two, they engaged in discussion. Ontario government, I wasimpressed, they were looking to cover those procedures and we went into a yearof discussions with them, providing them with data. But if you ever work withbureaucrats after a year, there was a change in the government and thatdepartment just vanished and it was under someone else. We were supposed tore-kick start that discussion with them again and that never happened.


Kim Wolf: Yeah, that's gotto be so discouraging. Is there a reason, " Why you think that the governmentmay not be stepping up to support these types of treatments moreactively?" Is it because they just don't have enough data or what do youthink the reason is for that?


Dr. Shammaa: Yeah, it's too tiered, I mean governmentsmove. Well, medicine moves very slowly compared to other sciences and then ontop of this, governments move even slower. With that in mind, to have thatchange seep through to the government is a very slow process. You have to gothrough the will of certain bureaucrats to push through initiatives. Beyondthat, you have to push through the government to actually approve specificfunding for big trials that they request. So for example, I'll give you theexample, that one of the issues we were discussing with the government at thetime was, they requested specific type of study data to show and that was fair.That specific type of study cost more than a hundred million dollar. Obviously,you don't have a big pharma again in Canada to come in and sponsor such a study.To show them what they want and they were not willing to shed the hundredmillion dollar from their own pocket at that point, this creates kind of thatschism. As small scientists, we can only do so much with the resources we have,to be able to convince them that this is the best way to move forward.


Kim Wolf: That being said- when you talk about, the fact that it is fairly new and that the government maynot be promoting it actively at this point, "How accessible is thetreatment for people?"


Dr. Shammaa: It's actually not bad in a sense, I have heardof the stories from my colleagues in the States that certain insurancecompanies do cover, the cell therapy, those procedures. In Canada, the onlyones that were able to get them covered were through their health expense. Interms of accessibility of the therapy itself, I mean, knees and hips are notthat difficult so you do have, I want to say, I can count probably thephysicians in Canada which is sad. But in the States, you have in every majorcity four or five very successful physicians who can easily do it. The spine isa unique one. We were first in the world who published the study. Today, I'mstill the first one in Canada to do those procedures. In the States, I am awareof two physicians, amazing physicians. One of them is in New York, he's inMount Sinai and the other one is in University of Texas. He conducts also theprocedure successfully. Those are the top guys as well that would be able to dothe spine successfully.


Kim Wolf: That being said,if we have people who are with us on the webinar today and it appears that wewe're getting a lot of questions about people in their personal situations. Ifthey're looking for access to you or to one of your colleagues, "Is therecapacity for that? And if so, what steps would they take?"


Dr. Shammaa: Yeah happily, I left my email on thepresentation, feel free to email me and then because it depends where you are.If I'm able to refer you to one of the colleagues in the States, who's able todo the procedure or here. If we can refer you to the center or if you're withinproximity then, we can get the managers to try to allocate someone, somewhereat least, that will be able to take care of the patient.


Kim Wolf: Okay, that'sgreat! I would assume , we'll have the recording and the presentation that willgo out to the people who joined us today. We can provide that contactinformation for them.


Dr. Shammaa: Of course.


Kim Wolf: Okay. We'veasked, we've had a lot of questions that have come through, and we've answeredthem. For those that we were not able to answer or that may be more specific totheir own personal situation, we will try to do a follow-up after the thewebinar today. I thank everyone for joining us and I certainly thank you Dr.Shammaa for sharing your experience and your expertise on something that Ithink is just continuing to evolve. I would expect that we'll hear more andmore about it over the next years.


Dr. Shammaa: Absolutely! Again,


thank you all forhaving me and thank you Kim for being a great moderator as well.


Kim Wolf: All right!Thanks everybody. Take care.