Author: The New Economy

Plastic surgery is on the rise, and the latest trend is high-definition lipo-sculpture: sculpting the perfect, muscular, athletic form into human bodies. Dr Alfredo Hoyos, leading Colombian plastic surgeon, explains the process.

The New Economy: Thinking of getting some sun in South America? How about a little nip and tuck while you’re there? Well, plastic surgery is of course on the rise around the world, and many are flocking to Colombia for their procedures. Here to tell us more is Dr Alfredo Hoyos.

Now, you specialise in high-definition lipo-sculpture; what does that involve?

Dr Alfredo Hoyos: Actually, that is my invention. It is what we call an advanced type of liposuction, and it involves two things. One is a technology, called VASER, which is literally something that can make you have a more defined job. And the other one is a technique, which is the one that I created. It involves having differential liposuction, which means that we have to do superficial and deep liposuction in order to get a more athletic appearance in the patients.

The New Economy: So how are you able to achieve high definition as you’ve just described, in someone who wants to have a six-pack?

Dr Alfredo Hoyos: Well, that’s a very interesting question, because there are people who are considered very good patients for doing liposuction. This liposuction is different, because it can be done in people who are not very perfect candidates.

So for instance, a person who is very athletic, but doesn’t have the six-pack, can now have the six-pack through this. And the person who is very slim, we can actually achieve a more athletic result as well.

And of course, in people who have a few kilos extra, we can take some out and we can do a little bit of finishing.

The New Economy: So, there’s obviously limits to how much success a patient can achieve?

Dr Alfredo Hoyos: Yes, of course. The idea is that we can do this in regular, normal patients. The idea is, not extremely overweight, not extremely obese patients, and not in patients who have… massive weight-loss patients, for instance. The ideal is to have very healthy patients.

The New Economy: So what then happens to a patient who puts on weight after the surgery?

Dr Alfredo Hoyos: Well, that’s very interesting. Because if you have athletic job, the idea is that people tend to conserve it over time. Usually, when you see the six-pack, and you are actually very fit: you go to the gym, you start a new trend of life. The thing is, this is what we call a dynamic surgery. It’s not like a nose job, where you preserve the shape over the years.

This is dynamic, in the sense that, if you eat… you’re going to lose the results if you don’t eat properly. You lose them over time.

The New Economy: Well I have to assume that many men are having this surgery; they’re the ones that, you know, like the six-pack on their abs. What else are men getting done?

Dr Alfredo Hoyos: We have an increasing perception of beauty and preservation in men as well. You know, it’s something that we didn’t have before. So, men actually want to get more healthy, and look younger, as well. So they want to have the six-pack, for instance. Usually, what we see over 40s or 50s, they try to have a bleph[aroplasty] done: you know, take out the extra skin on the eyelids; usually nose jobs. These are the most common surgeries that we do in men.

The New Economy: With respect to women, of course, breast implants seem to be all the rage, but PIP implants really come under fire recently – scrutiny being that, you know, these French-made implants were in some cases rupturing. When a woman is deciding whether she should have this surgery, what should she be keeping in mind when she’s shopping for the right surgeon?

Dr Alfredo Hoyos: There are two things that you have to have in mind. First, to have a board-certified surgeon. You know? We have to have very good training, and we have to keep updated in the field. So usually, board certified surgeons know what is best for you.

The second part is specifically about implants. And the main thing that we have to have in mind is that they are certified as well. That’s usually having an FDA approved, and CE approved – it helps us have a little more relief in that sense.

The New Economy: Dermal fillers now are kind of the wild, wild west of the cosmetic world – it’s so enticing, the idea of just being able to snap your fingers and reverse time. But there are some complications of course – can you tell me, how can someone decide what is the best type of filler to use, if they want to achieve the results and still be safe?

Dr Alfredo Hoyos: When you put a filler that is permanent, you can also have permanent complications. So usually what I recommend is to have temporary fillers. Something that is resoluble. And specifically hyaluronic acid – that is the one that we promote more, because it has very proven safety, it’s effective, and over time just goes away usually in a period of a year. Or nowadays almost two years.

But the main thing is that the patient can choose what he or she can have done later. If you say, ‘Oh, my cheeks were too high last time! Let’s put a little bit less in next time.’ So, it has these two advantages: that if you have a temporary complication, it’s gone in some period of time; and you can actually, over time, choose the best way and the best places to do it.

The New Economy: Now Colombia of course is one of the most popular countries to travel to for surgery. But if someone is trying to decide, don’t you think they should rather go with a local expert, versus someone who is overseas?

Dr Alfredo Hoyos: Usually the experts are not just in one place. So, usually if you want to find an expert in the face, you’ll go wherever you have to go to have the surgery with this specific person.

In the sense of Colombia, we have one of the safest and more advanced fields in plastic surgery in the world. We have the expertise as well. And the government itself is promoting to have medical tourism. So we’re building new hospitals, new clinics; everything has to be board-certified.

So I think the government backup is quite important for us as well.

The New Economy: Do you think that South America’s ever going to shake that reputation that it is somehow a cheaper alternative to seeking out surgery in the western world?

Dr Alfredo Hoyos: I think it’s a slow process. Because you have alternatives that, because of the economy, are actually cheaper than in first world countries. But I think slowly what we are seeing is that the patients are not coming because of having cheap surgery, but actually they are seeking the best surgeon to do the job.

People are becoming aware that when you do a surgery, sometimes it’s something that you have to choose carefully and rightfully, in order to get the best result.

The New Economy: Dr Hoyos, really that was such a fascinating conversation. Thank you so much.

Dr Alfredo Hoyos: Thank you very much for the invitation.

Dr David J Mazzo from Caladrius Biosciences introduces CLBS20, which has recently moved into its phase three trial – named the Intus trial. He explains how the drug works, discusses the stage two findings, and outlines his hopes for FDA approval in 2018.

The New Economy: Being diagnosed with cancer was once likened to receiving a death sentence. But great scientific innovations have helped patients in the fight against the disease. Here to put a spotlight on just one cancer immunotherapy that is in a phase three clinic trial stage: Dr David J Mazzo of Caladrius Biosciences.

First, can you tell me about your therapy that’s under development: what is it called, and how does it work?

David J Mazzo: Our therapy is actually called CLBS20, formerly known as NBS20. It is a therapy that is derived from the isolation of the cancer inducing cells that one finds in a melanoma tumour: those cells that are self-proliferating, and actually cause the metastases that ultimately result in in death when someone has late stage melanoma.

We teach that patient’s immune system, using their dendritic cells, to specifically target and attack those cells. The idea is to prevent the distant metastases and to prolong life.

The New Economy: Now, who is this treatment really targeted for? I mean, how is it different from other melanoma therapies, both on the marketplace and in development right now?

David J Mazzo: Well, the treatment is currently being studied in patients with late-stage melanoma – those that have what’s known as recurrent stage three or metastatic stage four melanoma. These are the people who are in the end stages of the disease, and have had an opportunity to try many other therapies, often without much success.

The other therapies that exist really fall into two general categories. There are those that are chemotherapeutic, and then there are those that are immunotherapeutic. And the chemotherapeutic agents are, if you will, selective poisons that try to kill cancer cells without doing much harm to the cells adjacent to the cancer – often without great success.

And then, the other immunotherapies that are in development are really looking at trying to unleash a latent immune response in a patient that is a naturally occurring response. And many patients don’t have that, so those types of immunotherapies – checkpoint inhibitors would be one example – have a limited success thus far in prolonging life.

Ours, because it focuses principally on the cancer inducing cells, looking to prevent the distant metastases, has shown in phase two a great potential to prolong life.

The New Economy: I see. Now tell me: what did the phase two data then show you?

David J Mazzo: Well, the phase two data actually was really compelling, from really a multitude of perspectives. In the first study that was done, which was just a single arm uncontrolled study, we demonstrated over the course of a five year follow-up a true, 50 percent survival rate in patients with the late stage melanoma.

That is somewhere between three and five times greater than the expected survival rate at five years for patients undergoing standard of care at the time of the study.

We then followed that study with a controlled, randomised study, where the control group was actually just our isolated and immobilised cancer-inducing cells, without the dendritic cell component. And of course the therapy was as described previously.

And in that study we demonstrated a 72 percent two year survival rate, versus 31 percent for the control group against the backdrop of approximately 25 percent anticipated survival rate for people receiving standard of care at the time.

So clearly a very statistically significant improvement in the reduction of mortality, and also great consistency of results from study to study.

The New Economy: So can you tell me now about a grant from the California institute for Regenerative Medicine that you received for this trial?

David J Mazzo: The achievement of a grant from them not only represents additional financial support – which is always helpful when conducting a large clinical trial – but also represents an endorsement of the potential that is viewed from this particular therapy in this particular medical indication.

The New Economy: Okay. So what are the details, doctor, of the phase three trial; and when do you hope for the treatment to reach the marketplace?

David J Mazzo: Well, our phase three trial, which has been named the Intus trial, is a trial that we hope will be confirmatory in comparison to the two phase two trials.

It is studying patients from the same patient population, using the same therapy, with the same dosing regimen and the same overall survival endpoint.

It’s enrolling 250 patients; it has actually been screening patients since earlier this calendar year. We’ve already randomised our first patient, and the goal is to have all patients enrolled within a 24 month period, and to be at the point of analysis of the first interim analysis after 99 events, sometime in the second half of 2017.

The anticipation is that we’ll be able to demonstrate a statistically significant improvement in the reduction of mortality at that time – and then the earliest possible biologic licence application will be filed in early 2018. With the fast-track designation that this programme has received from the FDA, we expect the earliest approval could come late in 2018.

The New Economy: Okay, very interesting. Dr Mazzo, thank you so much for joining me today.

David J Mazzo: I appreciate the interest in our company. Thank you very much.