We’ve all heard about embryonic stem cells (ESC’s). They have been in the news and the focus of controversy for a decade. We’ve seen far less media coverage of adult stem cells. Adult stem cells (ASC’s) are found in everyone’s body and they are capable of repairing a host of tissues. In fact, the research on adult cell lines has surpassed embryonic. Above is the result of a search I did yesterday in the National Library of Medicine, looking at all embryonic stem cell published papers vs. the total on all adult stem cell lines. As you can see, for every one ESC paper, there were at least two ASC papers. In addition, the research on ASC’s is vastly more mature, focusing on animal models of tissue healing, dosing, early human cases, medication interaction with cells, possible complications, etc… The ESC research is more test tube and review articles on what might be possible someday. Looking in specific categories, I found the following:
· Cartilage Repair: 230 articles on embryonic vs. 1,113 for just one adult stem cell line (mesenchymal stem cells)
· Myocardial Infarction: 186 for embryonic stem cells vs. 341 for adult mesenchymal stem cells, 69 for endothelial progenitor cells
· Wound Healing: 114 for embryonic stem cells vs. 330 for adult mesenchymal stem cells, 565 for adult epithelial stem cells
For a more detailed analysis, take a look at the American Stem Cell Therapy Assocition (ASCTA) white paper on adult stem cells vs. embronic stem cell research. Summary? Adult stem cell research is much farther ahead. In addition, as I have posted on before, if the cells are autologous (from the same patient), they also have a much lower risk profile. While one day embryonic cells may rule the day, for now, adult stem cells are beating the pants off ESC’s in practical research.
Great local news story this morning on one of our patients. While we have treated many ankle problems including ligament tears and loss of cartilage, Hal was undeniably the worst. He had a surgeon attempt a triple arthrodesis (fusing all three main ankle joints) and one of those screws inadvertently blocked an artery that was necessary to keep portions of his talus bone alive. The bone died and then collapsed. When we first saw him 1-2 years later, the x-ray of his ankle looked like someone had taken a bunch of screws from the hardware store and thrown it at the screen. We told Hal that he was a poor candidate for our procedure using his own stem cells, but he felt so burnt by traditional orthopedic surgery that he had to give it a whirl. To our surprise, Hal went from not being able to walk 100 yards to being able to play 18 holes of golf and exercise on a treadmill.
This also brings up a news story from last week, where British scientists have experience treating 1500 horse tendon tears with mesenchymal stem cells and now plan to begin treating humans as well. This is similar to the experience of vetinarians here at the CSU Orthopedic Research Center. The moral of the story? Ankle patients need to stay away from hardware stores.
This patient was treated with the Regenexx-C (cultured stem cell injections). In addition, not every patient we treat with severe ankle arthritis can expect to see the same results as Hal.
We are at a cross roads in cellular medicine. Adult stem cells have become very mature in their animal models of treating a wide variety of diseases including orthopedic, cardiovascular, internal organ disease (such as diabetes), etc… This morning’s news of the patient’s own adult stem cells treating heart attack in a dose dependant fashion is not surprising. This story of adult stem cells helping with heart repair illustrates this fork in the road well. Here a big pharma style company is trying to commercialize the patient’s own stem cells through an FDA approval process. However, these are simple selected CD34+ cells, so this could also be readily done in a physician run stem cell lab. The difference? Cost for one. Tens of millions of dollars will be spent going through this drug process to ultimately manufacture these cells to have a “product shelf life”. That last part doesn’t make sense, since they are the patient’s own stem cells. Are the patient’s own adult stem cells a drug? The FDA has asserted they are, but there are many physicians who would disagree. These physicians are creating stem cell lab guidelines to allow safe medical practice through the American Stem Cell Therapy Asasociation. A recent press release codfies their position as being opposed to the FDA. Patients are also now getting together to oppose this FDA position.
Last summer we got a letter from the FDA stating that they felt that our Regenexx medical procedure was actually the manufacturing of a new drug. This letter made no sense, as what we’re doing is practicing medicine. We kindly wrote back stating our position and then we didn’t hear back for more than half a year. Recently, the FDA has again asserted that they believe we are manufacturing a drug. They haven’t given any credible rationale for why they believe this, as what we’re doing with adult stem cells is no different than the average fertility clinic that grows embryos in culture for re-implantation. The fertility clinic is not regulated as a drug manufacture facility. The fertility specialists fought that fight and won.
ASCTA is a physician organization that was formed in opposition to the FDA’s position that adult stem cells are drugs. This group heralds a much bigger movement than what we’re doing here with the Regenexx-C procedure. We’ve found literally an outcry by patients with chronic diseases that the FDA would stand in their way of getting safe stem cell work performed by their doctors. We agree that there are hundreds of likely unsafe stem cell outfits around the globe injecting God knows what into whoever has the will to pay. All the more reason for an organization to step to the forefront to establish physician run guidelines for safe lab practices and clinical oversight.
The pre-clinical research on adult stem cells is much stronger than embryonic stem cells. The research community would agree that your own adult stem cells are likely the least risky of the lot (between embryonic, cord blood, or someone else’s adult stem cells). When I’ve posed the question to numerous doctors and experts in the field, are your own stem cells drugs? They look at me like I’m crazy, and often reply, “Of course my stem cells aren’t drugs!”. Why would the FDA take the position that your cells are drugs? Like anything, there’s more to the story. The best business model for stem cells is someone else’s cells (adult or embryonic) in a vial. These can be manufactured like drugs, crazy things can be done to them like inserting genes to improve their patent-ability, and then sold wholesale into the drug distribution pipeline.
The ASCTA physician group will be getting out it’s lab practices guidelines meant to hold new adult stem cell practices to the highest standards to protect patients. Our goal is clear and it’s a fight worth fighting…Safe Stem Cells Now!
This blog post refers to the Regenexx-C procedure.