CHICAGO, Ill. (Ivanhoe Newswire) -- No matter what your age, when cartilage begins to wear out around our knees or becomes damaged, it can limit our movement and cause serious pain. Now, a new technique using stem cells from donor umbilical cords, typically discarded after birth, could help young patients rebuild cartilage and reduce pain.
Chasing after his son Jimmy hasn’t been easy for Jim Hackett.
“I figured two years down the road, I want to be able to run around with him and play ball with him, but at the rate I was going, that wasn’t going to happen,” Jim Hackett told Ivanhoe.
Years working as a police officer have taken a toll on his knees.
“It just gets to the point where your knee just says enough and you end up with cartilage problems,” Jim said.
Dr. Brian Cole is using stem cells to repair Jim’s cartilage.
“Several small holes are made into the bone to make it bleed intentionally and in that blood are our own body’s stem cells that lay down fibrocartilage or scar cartilage,” Brian Cole, MD, MBA Professor, Department of Orthopedics, Section Head, Rush Cartilage Restoration Center, told Ivanhoe.
Then stem cells from umbilical cord blood are combined with hyaluronic acid, a building block of cartilage.
“The hope is through acting as a regulator, in that area, they can actually improve the healing response,” Dr. Cole said.
Jim is back on his feet.
“My knees are great. I’m able to kneel now and before, prior to surgery, I wasn’t able to do that,” Jim explained.
The therapy’s been approved in South Korea and preliminary results here are promising. The best patients for the procedure are under the age of 45 with small localized areas of cartilage damage. It’s not meant for older patients with arthritis or in place of a knee replacement.
Brian Cole, MD, Professor, Department of Orthopedic Surgery, Rush University Medical Center, Section Head Rush Cartilage Restoration Center, Team Physician for the Chicago Bulls, Co-Team Physician for the Chicago White Sox, talks about healing knee pain with stem cells.
We are talking about this new trial CARTISTEM. Can you tell us a little bit about it, how it has been approved, in other countries and is just now making its way here?
Dr. Cole: So, CARTISTEM is a technology that has been investigated in Korea. It’s a biotechnology company that has been in existence for a number of years utilizing donor stem cells, in this case, placental cord blood. So they’re adult donor stem cells captured from placental cord blood that are combined with hyaluronic acid which is a building block of cartilage and utilized as an adjunct to an existing technique called microfracture. The technique and the technology is not approved here yet in the United States, but rather it’s going through the rigors of the regulatory process within the United States to obtain approval.
How does it work then in tandem with microfracture surgery?
Dr. Cole: So, microfracture is an accepted technique utilized to treat localized cartilage defects that otherwise would not heal by themselves. This technology is not for arthritis, but for small spots of cartilage loss typically in relatively young patients where only one small surface is involved, yet is causing pain and impairment. Microfracture is a technique where the defect is cleaned off arthroscopically through the camera. Several small holes are made into the bone to make it bleed intentionally and in that blood are our own body’s stem cells that lay down fibrocartilage or scar cartilage. This technique with CARTISTEM is an adjunct to microfracture. It is designed to hopefully make the maturation process more successful and improve the outcomes of microfracture which can be challenging in certain patient populations. So the technique is to do a relatively standard microfracture, but add on top of it a paced or emulation of the hyaluronic acid which is sort of a lubricant cartilage building block that has added to it donor stem cells to improve upon the healing process after microfracture.
And that is something that is used in a lot of baby products too, and for skin rejuvenation, and that type of thing?
Dr. Cole: Yeah, so hyaluronic acid itself is used as we know in beauty products and so forth. Stem cells are obviously very new and it is important to understand the way these cells work. It is not likely that they themselves will become the final product or the final tissue, but rather they work to modulate the environment to provide a source of growth factors to induce more stem cells to come into the area. They are very potent immune modulators. They reduce the immune response, the inflammatory response and the hope is through acting as a regulator in that area, they can actually improve the healing response when it is combined with the hyaluronic acid.
So they are not necessarily regenerating the cartilage?
Dr. Cole: Yeah, I think people have to understand there is always this vision that stem cells offer this magical ability to regenerate new tissue once its broken or defective, but in actuality at least in this application, the cells themselves are really important mediators, they sort of help organize the environment to create a more hospitable, predictable healing response that otherwise wouldn’t occur if they were absent.
So what is the recovery time like versus your typical surgery?
Dr. Cole: The recovery time with CARTISTEM is somewhat similar to microfracture; in other words typically patients are placed on crutches for 4 to 6 weeks, often do not have to use a brace. They are encouraged to use range of motion or even a machine that helps to move their knee and then the time course in terms of how long it takes to feel better can be 4, 6, 8, 12 months. There is a gradual progression of improvement that can actually continue for upwards of 12 months.
Do we have any, um stats though that would show with the CARTISTEM the healing was able to be better than microfracture?
Dr. Cole: There is some initial data that has been obtained from a clinical setting in Korea comparing about 100 patients who have either been randomized to microfracture as traditionally described which is what we commonly do as a first line treatment for relatively small defects compared to microfracture with CARTISTEM. And, the results in the clinical scores as well as MRI imaging were superior in that group that had CARTISTEM. So, the results right now are very encouraging that will do at least as well as we do with microfracture and hopefully much better. The challenge with microfracture is that there is a certain percentage of people that don’t get better at all after the operation and then there is another percentage that after it’s done, actually deteriorate between 2 and 4 years out. So our hope is that we can improve the response rate of those who otherwise may not respond and also improve the longevity of the outcome.
So, the CARTISTEM you think might be that catalyst to help other people respond?
Dr. Cole: Yeah, so our belief based upon the basic science is that we will hopefully increase the number of responders or the number of people who otherwise wouldn’t respond to traditional microfracture and improve the duration of the response over time.
Is there a particular percentage of patients that don’t respond, that you know of?
Dr. Cole: Well, there is a percentage of patients with microfracture that don’t response, that don’t get a positive outcome. As far as with CARTISTEM, it’s too soon to say.
Is it a small percentage of people that don’t respond?
Dr. Cole: I would say that with microfracture, a couple of things happen. We tend to treat the best defects. In other words we try to eliminate patients who are not likely to respond: so please keep in mind and this is very important, this is not for arthritis. This is not an alternative to knee replacement. These are typically very young patients who don’t have arthritis on both sides of an opposing surface, but rather just a local spot of cartilage loss. Very different entity than the traditional patient who has been told they needed knee replacements, so we have to be very clear who this population is. Now, these defects in general are relatively rare. The larger they are, the less responsive they are to microfracture. So, our current literature and the literature that we have from our institution at Rush indicates that patients up to about 4 to 5 square centimeters when that is the only problem tend to have a pretty predictable response with marrow stimulation. But if we look at all comers who undergo marrow stimulation or microfracture the response rate may only be 60 to 75%.
So, what would be just a typical reason why someone may have damaged their knee then, what population?
Dr. Cole: Yeah, the most common patient that we are speaking about here is someone who has either had a traumatic injury that has led to some type of cartilage injury or cartilage loss or even more common is someone who has localized cartilage loss that is just through wear and tear and local degeneration and it can actually happen in any age group. We see it in all ages, all comers. In other words over time, cartilage in certain parts of the knee and other joints, we treat children with cartilage problems very similarly, can have localized area of wear that can breakdown and its’ something beyond our control, and it is not necessarily tied into a specific injury.
What is the story about age range usually, the younger population?
Dr. Cole: The majority of these patients will be less than 40 and that is just because as patients are over 40, they have typically lived with their arthritic or localized spot of lost cartilage for enough time that they get progressive degeneration around the area to the point where even the opposing surface is involved. We will find patients under 50 between 40 and 50, but it is extremely rare. The vast majority will be 45 and younger.
Okay, what do you think that something like CARTISTEM means for the future of medicine?
Dr. Cole: I think as a model to enhance healing, it has a significant potential impact. It is not just to treat cartilage problems. There are other areas where we have a challenge in terms of harnessing our body’s ability to heal. For example when we repair rotator cuff, muscle tendon tears in the shoulder, we see re-tear rates that exceed 50% in some tendon tear patterns. If we have ways to stimulate the body’s predictability in terms of healing, donor stem cells may have a tremendous value for us in the future. The real challenge is that the regulatory environment is so difficult to get these new products to market and when we are trying to show differences to existing techniques; it becomes very difficult from a proof of concept point-of-view to actually show in a scientific fashion that it is effective and predictable.
So you said once the stems get approved that there is a chance that it could be used for larger issues with the knee, like what would be an example? What do you foresee happening?
Dr. Cole: The first phase of the trial is very small defects, but what would happen is that the application would be extended to larger defects to assess for response and that is part of the planned investigations; to start with small and then goes to slightly larger defects. If the proof of concept is there from a scientific perspective, then it would allow us to treat defects that we otherwise wouldn’t be able to treat effectively with a relatively simple technique like microfracture.
How far along is this study here?
Dr. Cole: Well, there is only 2 sites in the country, us and one of the Harvard hospitals that are enrolling patients, and we have enrolled 2 of the first 5. We are likely going to enroll up to 10 patients depending on the way the study unfolds, and again this is only the phase 1. There is going to be 3 phases, most likely the phase 3 will be a very large population of patients, you are talking about several hundred patients.
So, I mean, we are at the very beginning?
Dr. Cole: Yeah. This is still very early, yet exciting stuff.
How big of a breakthrough would you say this is?
Dr. Cole: I’d say this is an evolutionary breakthrough. I am not going to call it revolutionary, because I think we are still going to see challenges down the road. The problem with cartilage issues is that many times the treatments we render are not necessarily an off switch. In other words, it doesn’t shut it down and turn it off, but rather it creates an environment where they have significantly less pain, less swelling and thus more ability to function. It’s a really challenging issue and lots and lots of people suffer from these problems.
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