Author: OneMedPlace Team
Intellicell BioSciences (OTC: SVFC) has pioneered a unique method of acquiring stromal vascular fraction cells derived from the blood vessels in the adult adipose tissue. The company’s proprietary protocol can separate adult autologous VFC cells from the adipose tissue without the use of enzymes. Because Intellicell does not use endotoxins and enzymes, the company believes the process meets the manipulation requirements of the FDA.
As such, the autologous VFC cells are available for use by physicians and laboratory and treat patients today.
Intellicell has demonstrated the process is faster (about 30 minutes vs. 2 hours), less expensive, and more efficient than protocols using endotoxins and enzymes.
VFC cells include autologous pluripotent adult stem cells, endothelial cells, progenitor cells, fibroblast cells, red blood cells, and white blood cells, a diverse cell population believed to be synergistic and able to communicate with other cells in their local environment. IntelliCell Biosciences has developed its own patent pending protocol to separate adult autologous vascular cells from adipose tissue without the use of enzymes. IntelliCell will also be seeking to develop technology licensing agreements with technology developers, universities, and international business entities.
Intellicell is now exploring clinical studies in autologous cellular treatments for osteoarthritis, periodontal (gingival gum regeneration), aesthetics (wrinkle market), sports medicine injuries, and multiple sclerosis.
Speaking with OneMedRadio earlier in October, Intellicell CEO Dr. Steven Victor outlines the company’s clinical success in these areas, in which the company’s SVC cells have had significant success. Dr. Victor also discusses the company’s unique process and the promise of autologous SVC cell therapies.
Listen to the OneMedRadio, and view the transcript below.
Matthew Margolis: Greetings from OneMedRadio, I’m Matt Margolis. Today, I’m with Dr. Steven Victor, Chairman and CEO of Intellicell BioSciences, a New York City-based regenerative medicine company developing a medical process resulting in the acquisition of stromal vascular fraction cells. These cells are known to contain significant numbers of various cell types and the company is exploring applications in osteoarthritis and sports medicine injuries as well as aesthetics and periodontal. Intellicell trades under the symbol S-V-F-C on the OTC market. Thank you for joining us, Dr. Victor.
Steven Victor: It’s a pleasure to be here, Matt.
MM: So let’s start with these cells and Intellicell’s proprietary technology. What exactly are stromal vascular fraction cells?
SV: Okay. So in the world, there’s about 120 companies who take adipose tissue commonly known as fat and use an enzyme to process the fat to remove what we call the stromal vascular fraction cells that actually sit in the blood vessels in the fat. As a matter of fact, if you look at the body, every single blood vessel in the body have stromal vascular fraction cells and these are the cells that the body releases when you injure yourself to repair your cells.
Intellicell BioSciences, what we did we found a way of removing these cells by a mechanical means called ultrasonic cavitation so we don’t have to use any enzymes and that’s a really important point especially in the FDA in the United States because in the FDA, if you use an enzyme, they consider that maximal manipulation because the enzymes can produce things like endotoxins. But just using high frequency sounds waves, there’s no endotoxins. It’s a mechanical way of removing the stromal vascular fraction from the blood vessels so we meet the minimal manipulation requirements of the FDA, which puts us into the 1271.1 or 361, which makes us exempt so we can actually treat patients today.
MM: Let’s take a step back and talk about the company profile. You know, what is Intellicell BioSciences at the employee level?
SV: So Intellicell BioSciences has what’s called the CGTP FDA approved lab, what we call SOP, standard operating procedures, and we have a quality assurance director, we have lab technicians. So if you came into the flagship office on Park Avenue, you see a very sophisticated, well run laboratory with all the standard flow cytometry, isolation hood, everything is done under a very sterile environment. Because remember these cells are taken out of the fat of a person, they’re given back to another person, the same person for treatment so it’s very important to really run the lab in a very high quality CGTP environment with SOPs for sterility and trackability.
Then we have a director of research because right now under the FDA, we’re doing it as minimal manipulation autologous and homologous so we don’t make any clinical claims. So Intellicell manufactures the stromal vascular cells, return the cells to the physician, and then it’s the physician’s choice with consultation with the patient of how they’re going to be treated. So what our director of clinical research is doing, he’s organized several clinical studies, one for osteoarthritis of the knees, one for gum recession would be so far we’ve grown back in the mouse so you won’t need any more surgery, and we’re looking at the aesthetic market or the wrinkle market. So he’s in the process through IRB, IND, FDA trials of organizing these studies and right now, we’re just waiting for the final IRB approvals to begin these trials. So in the near future, we’ll be able to actually make clinical claims for our cellular population instead of just being homologous.
MM: So for the applications that you’re exploring, why are these areas of unmet medical need?
SV: Well if you look at osteoarthritis of the knee, which is the first one we’re looking at, it’s really an unmet clinical need. There is no really good treatment. If you look at steroids, they temporarily make you feel better but at the same time, they’re actually dissolving the bone. So right now in the world of osteoarthritis of the knee, there’s no really great therapeutic modality from exercise to surgery or even medications. We have found with the stromal vascular fraction, we’ve been able to grow back cartilage, we’ve been able to grow back meniscus tissue, we’ve been able to reduce the inflammation to tremendous differences. We use what we call the WOMAC schedule, which is a way of measuring pain and mobility and we’ve seen about an 85% to 95% improvement in these patients that can last up to two or three years. We’ve also grown back cartilage in knees that were bone on bone on MRI. This is one area where there’s a tremendous need for better therapy and we really believe that the stromal vascular fraction is a way of doing it.
In the world of periodontistry, if you’ve ever had a gum recession, in order to fix that, they’d take flap on the roof of the mouth, they have to then graft it into the gums, which is extremely painful. It has 75% take rate and you don’t get total regrowth of the gums. We’ve done so far 10 patients with the periodontist where he’s injected these cells directly into the gums with no other surgery and he’s been able to grow back 99% of the gums in the mouth. So this is a new way of doing this, which will basically prevent surgery, the healing is easy, healing is fast and you have a much better gum regeneration. In addition, he’s able to grow bone in the jaw so people who have, you know, loose teeth or things like that will be able to inject these cells and basically grow new bones so that people won’t lose teeth.
In the aesthetic world, it’s the wrinkle world. It’s basically a way of doing your wrinkles not only to generate the wrinkles but just give you younger skin. So we’re pretty excited about these three fields that we’re focusing on. We believe that the osteoarthritis world is probably over $10B market, the periodontal world is $6B, and then the aesthetic world is probably about a billion plus.
MM: And so what does your clinical progress look like in these applications?
SV: Well understanding what’s interesting what we had to do because we actually manufacture stromal vascular fraction and give them to physician so these indications have all been treated by physicians with high degree of success. So in osteoarthritis of the knee, there’s been over 75 patients treated with clinical improvement up to 85% to 95% on the WOMAC scale. We’ve grown back cartilage on MRIs and in the periodontal world, we’ve grown back gums in ten patients, we’ve grown back bone in the joint in two patients. In the wrinkle world, we’ve treated over a hundred patients for wrinkles with success.
So what’s interesting about what we’re doing because we get to return the cells to physicians under homologous minimal manipulations, they’re actually using cells on patients. But you know the in pharmaceutical world, a lot of the studies that are done, they look good in a small population. Then the medication goes into the bigger population, double blinded and when you open the final envelope at the end of the day after hundreds of millions of dollars and years of studies, you find that the medication doesn’t work.
In our case, we actually are able to use these cells in the clinical arena by physicians so we actually know that we’re going to get a positive outcome even before we start our clinical studies for indications. So these clinical studies will be double blind. They’ll be under IRB, IND with the FDA so we can’t make clinical claims but we know at the end of the study we’re going to get a positive result, which is so different than the world of drugs and pharmaceuticals.
MM: Let’s shift gears a little bit, let’s talk about your IP position. So do you view it as advantageous and favorable?
SV: Well we were the first company to show that you can take a mechanical way in this case ultrasonic cavitation. Other people have tried to do this and ultrasonic cavitation is normally used to lyse cells or blow up cells. We’re able to figure out five parameters if you follow exactly the recipe or the protocol instead of blowing up the cells, you actually keep the cells viable. We’ve shown this in tissue culture. We’ve marked the cells with CD anti-markers, we have this population of cells and all the mesenchymal stems cells that are identical to anybody processing these cells with enzymes.
However, because we don’t use enzymes, which are very expensive, our procedure is much less expensive. It’s actually ten times less expensive. It’s faster, it only takes 30 minutes versus two hours and we’re able to produce more cells from less fat than the enzymes. Most importantly, as I said earlier, because we don’t have any endotoxins or enzymes involved, we’re not adding anything, we’re just using a mechanical way of separating the cells, we believe that we’re under minimal manipulation with the FDA. So we make more cells, we make them faster, we make them cheaper, and we make them better than the enzyme world.
MM: So let’s talk about your most recent news. On October 4th, the company announced that it had been granted a research tissue banking license by the New York State Department of Health. Why is this significant?
SV: Well what we’ve discovered which we filed a patent for also, right now as we talked about whether the enzyme world or our ultrasonic cavitation where, we’re manufacturing stromal vascular fraction from adipose tissue from living patients or living people. We discovered that we could take cadaveric or nonliving tissue or organ donors, we can take their fat. We can use our technology and our protocol on that fat and we can actually produce stromal vascular fraction cell in the same quantity, the same quality as in living tissue. So we’ve done this in multiple times, we’ve now tested it and with the license, we’ll be able to actually manufacture these cells from nonliving cells and we’ll be able to sell them to researchers around the world. So we can really now see a big advance in the world of stromal vascular fraction because prior to this it was very difficult for researchers to obtain adipose tissue or fat from the liposuction doctors believe it or not. So we think there’s going to be a big skyrocket in research and in advancements and discoveries in the world of stromal vascular fraction for treating all kinds of clinical indications.
MM: And what can we expect from Intellicell BioSciences in the next few months and what business development milestones are you seeking?
SV: Well basically, we’re open. We’re in the process of finishing our ambulatory surgery center, which we open in about 30 days to 60 days. We believe that it will do from 10 to 12 million dollars a year with about 25% to the bottom line. The reason we’re running this business model because the FDA wants us to run the CGPT lab. They want us to basically be able to monitor the clinical experience of the patients. They want us to monitor the market into physicians. By owning the ambulatory surgery centers, we basically meet all the needs of the FDA to regulate these cells. Once we open our facility in New York on Park Avenue, we have plans for acquisitions of other ambulatory surgery centers in the country where we can then put our cellular tissue processing labs and turn that ASC into a cellular center for treatments of again we’re going to focus on the sports world, the osteoarthritis world, the periodontal world, and the aesthetic world. So it’s a way of expanding our model that we can easily expand our model throughout the country.
MM: That was a company snapshot with Dr. Steven Victor of Intellicell BioSciences, a New York City-based regenerative medicine company developing a unique process to acquire stromal vascular fraction cells. Intellicell trades under the S-V-F-C on the OTC market. With OneMedRadio, this is Matt Margolis signing off.